Autolus Therapeutics Presents Updated Clinical Data from the CARLYSLE Trial in Patients with Severe Refractory Systemic Lupus Erythematosus at the American Society of Hematology (ASH) Annual Meeting 2025

Rhea-AI Summary

Autolus (NASDAQ: AUTL) presented updated Phase 1 CARLYSLE data for obe-cel in severe refractory systemic lupus erythematosus (srSLE) at ASH on Dec 8, 2025.

Nine adults were infused (six at 50×10^6 cells, three at 100×10^6). At 50M, CRR 50% (3/6) and DORIS 83% (5/6) were reported with median DORIS onset 5.1 months and median follow-up 12 months. All patients showed deep B-cell depletion; median CAR T-cell persistence was 3.0 months and peak expansion at a median of 10 days. Safety: no DLTs at 50M, no ICANS, Grade 1 CRS in three patients at 50M and three at 100M; one transient Grade 3 liver toxicity in 100M cohort; hypertension observed in five patients at 50M.

50M chosen as recommended Phase 2 dose; LUMINA Phase 2 in lupus nephritis with registrational intent is now enrolling and aligned with FDA.

Positive

• Nine patients dosed in Phase 1 safety/efficacy readout
• 50M cohort: CRR 50% (3/6)
• 50M cohort: DORIS 83% (5/6) with median onset 5.1 months
• All patients showed deep B-cell depletion consistent with immune reset
• Median CAR T-cell persistence 3.0 months; peak expansion median 10 days
• 50M selected as recommended Phase 2 dose; LUMINA Phase 2 enrolling

Negative

• Only nine patients reported; 100M cohort limited to 3 patients
• Median CAR T-cell persistence of 3.0 months may limit long-term persistence
• Hypertension in 5 patients at 50M (three had prior history)
• One transient Grade 3 liver toxicity observed in 100M cohort

Key Figures

Patients infused 9 patients Phase 1 CARLYSLE srSLE trial; obe-cel infusions

Dose cohorts 6 at 50×10^6; 3 at 100×10^6 CAR T-cells Phase 1 CARLYSLE dose levels

DORIS remission rate 5/6 patients (83%) 50M dose; median onset 5.1 months

Complete renal response 3 patients (50%) 50M dose cohort in srSLE

Median onset of DORIS 5.1 months (range 4.9–8.9) 50M dose; CARLYSLE trial

Median follow-up 12 months (range 8.5–16.3) 50M dose; disease activity monitoring

Peak expansion timing 10 days median (range 9–13) CAR T-cell expansion after obe-cel infusion

CAR T persistence loss 3.0 months median Kaplan-Meier analysis of CAR T-cell persistence

Market Reality Check

$1.59 Last Close

Volume Volume 1,574,459 is below the 20-day average of 3,904,485 (relative volume 0.4). low

Technical Price 1.55 is trading below the 200-day MA of 1.73 and 51.26% below the 52-week high.

Peers on Argus 1 Down

AUTL was down 1.27% pre-news with below-average volume while close peers showed mixed moves (e.g., ADCT -6.53%, BNTC +2.41%). Momentum scanner only flagged FULC -6.70%, indicating stock-specific rather than broad sector momentum.

Common Catalyst Select biotech peers, such as CGEM, also reported ASH 2025 clinical trial data, highlighting a conference-driven news cluster rather than a unified price trend.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 01	Board appointment	Positive	-2.1%	Experienced former BioNTech executive added to support commercialization.
Nov 25	Regulatory decision	Positive	+12.1%	NICE draft guidance recommending AUCATZYL for adult r/r B-ALL.
Nov 13	Conference participation	Neutral	-5.9%	Jefferies healthcare conference fireside chat and webcast availability.
Nov 12	Earnings update	Neutral	-9.3%	Q3 2025 results with product revenue and cash position disclosure.
Nov 03	ASH data preview	Positive	+0.7%	Announcement of ASH abstracts with obe-cel updates in multiple settings.

Pattern Detected

Recent news often drew muted or negative price reactions, even on positive operational or clinical updates, with only select regulatory wins showing clear positive alignment.

Recent Company History

Over the last months, Autolus advanced from commercial launch execution to broader clinical and regulatory milestones. Positive NICE draft guidance for AUCATZYL on Nov 25, 2025 saw a 12.1% gain, while the Q3 results on Nov 12, 2025 with $21.1M net product revenue and $367.4M cash/marketable securities were followed by a -9.33% move. Prior ASH and conference data releases produced modest or negative reactions. Today’s CARLYSLE update extends this clinical narrative in autoimmune disease on top of oncology use.

Market Pulse Summary

This announcement highlights updated Phase 1 CARLYSLE data in severe refractory SLE, showing deep B-cell depletion, high DORIS remission rates at the 50M dose, and a generally manageable safety profile. It builds on prior autoimmune and oncology experience with obe-cel and confirms FDA alignment on a Phase 2 LUMINA trial in lupus nephritis. Investors may track enrollment progress, durability of responses beyond the current follow-up, and how these autoimmune efforts complement the existing commercial B-ALL franchise.

Key Terms

systemic lupus erythematosus medical

"obe-cel), a CD19-targeting ... in patients with severe, refractory systemic lupus erythematosus (SLE)"

Systemic lupus erythematosus is a chronic autoimmune disease in which the body's immune system mistakenly attacks healthy tissue, causing inflammation that can affect skin, joints, kidneys, heart, lungs and other organs. It matters to investors because disease severity, prevalence, and gaps in effective treatments drive demand for new drugs and diagnostics—think of it as a large, persistent market need where a successful therapy can change patient outcomes and create significant commercial value.

chimeric antigen receptor medical

"obe-cel), a CD19-targeting chimeric antigen receptor (CAR) T-cell therapy, in patients"

A chimeric antigen receptor is an engineered protein added to a patient’s immune cells that gives them a new, specific ability to recognize and attack cells carrying a particular marker (antigen) — like equipping police with a facial‑recognition app to find a suspect. For investors, CARs are the core technology behind targeted cell therapies: their clinical success, manufacturing complexity, safety profile, and regulatory approval determine treatment market potential, development costs, and company value.

car t-cell therapy medical

"a CD19-targeting chimeric antigen receptor (CAR) T-cell therapy, in patients with severe"

Car T-cell therapy is a medical treatment that uses a patient’s own immune cells, modified in a lab to better recognize and attack cancer cells. It is considered a breakthrough because it offers potentially long-lasting effects for certain types of cancer. For investors, its development and approval can signal advances in healthcare innovation and potential growth opportunities in the biotech sector.

cytokine release syndrome medical

"No dose limiting toxicities (DLTs) or cases of immune effector cell-associated neurotoxicity syndrome (ICANS) were observed at the 50M dose. Grade one cytokine release syndrome (CRS) was observed"

An intense immune overreaction in which the body's defense system releases a large surge of signaling proteins, causing fever, low blood pressure, breathing trouble or organ stress; imagine the immune system's alarm going into overdrive and flooding the body with emergency responders. Investors care because this side effect can slow or block regulatory approval, increase clinical trial costs and liabilities, limit how widely a therapy can be used, and therefore affect a drug's market value and sales potential.

immune effector cell-associated neurotoxicity syndrome medical

"No dose limiting toxicities (DLTs) or cases of immune effector cell-associated neurotoxicity syndrome (ICANS) were observed"

immune effector cell-associated neurotoxicity syndrome (ICANS) is a brain-related side effect that can occur after treatments that activate powerful immune cells, such as engineered cell therapies. It can cause confusion, speech problems, seizures or coma when the immune response unintentionally harms brain function; think of an overenthusiastic security system that starts damaging the house it’s protecting. Investors care because ICANS affects clinical trial results, regulatory approvals, product labeling, treatment adoption, monitoring costs and potential liability, all of which influence a therapy’s commercial value.

AI-generated analysis. Not financial advice.

• Data show deep, durable responses in the 50 million cell dose level cohort; initial data suggest substantial early improvement in three patients dosed with 100 million cells
• All patients show deep B-cell depletion after infusion, suggesting an immune reset
• Nine patients were evaluable for safety, no ICANS or high-grade CRS were observed
  

LONDON and GAITHERSBURG, Md., Dec. 08, 2025 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc (Nasdaq: AUTL), an early commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, announces presentation of preliminary data from the ongoing Phase 1 CARLYSLE trial in patients with severe refractory systemic lupus erythematosus (srSLE) in an oral presentation at the American Society of Hematology (ASH) Annual Meeting.

Dr. Matthias Will, Chief Development Officer of Autolus, said: “Patients with srSLE have limited remaining treatment options and represent a difficult to treat population with a critical unmet need. Data reported from the CARLYSLE trial show an encouraging high rate of DORIS responses and a deep reset in the B cell compartment induced by obe-cel, suggesting the possibility for an immune reset. Based on this positive initial experience with obe-cel in the CARLSYLE trial we have initiated the LUMINA trial, a Phase 2 trial in lupus nephritis with registrational intent.”

Abstract 302
Title: Obecabtagene autoleucel (obe-cel), a CD19-targeting chimeric antigen receptor (CAR) T-cell therapy, in patients with severe, refractory systemic lupus erythematosus (SLE) in the Phase I CARLYSLE study: initial safety, preliminary efficacy, pharmacokinetics, and biomarker results
Session Name: Cellular Immunotherapies: Early Phase Clinical Trials and Toxicities: Emerging CAR-T Cell Therapies for Acute Leukemias and Autoimmune Diseases
Session Date and Time: December 8, 2025; 11:30 – 11:45am ET
Session Room: Orange County Convention Center; Valencia Room W415D
Publication Number: 815
Presenting Author: Claire Roddie, MD, PhD, FRCPath, Associate Professor Haematology and Honorary Consultant Haematologist, Cancer Institute, University College London (UCL)

Summary: Updated Phase 1 data with longer follow-up, and data in patients who received both 50×10⁶ (50M) and 100×10⁶ (100M) CAR T-cells were presented. Nine adult patients were infused with obe-cel, including six at the 50M dose and three at the 100M dose.

Obe-cel was well tolerated in all patients. No dose limiting toxicities (DLTs) or cases of immune effector cell-associated neurotoxicity syndrome (ICANS) were observed at the 50M dose. Grade one cytokine release syndrome (CRS) was observed in three patients at the 50M dose and three patients at the 100M dose. Hypertension was observed in five patients at the 50M dose, with three of those patients having pre-existing history of hypertension. A case of transient Grade three liver toxicity was observed in one patient of the 100M cohort.

At the 50M dose, three patients (50%) achieved CRR and five patients (83%) achieved DORIS with a median onset of 5.1 months (range: 4.9–8.9), without evidence of new disease activity at a median of 12 months of follow up (range: 8.5–16.3). All non-renal manifestations of the disease resolved by month four. Urinary protein creatinine (UPC) ratio levels decreased over time, demonstrating significant decline or absence of disease activity. Data show high peak expansion and deep B cell aplasia consistent with known obe-cel characteristics in oncology indications. Peak expansion was reached at a median of 10 days (range: 9–13). The median time to loss of CAR T-cell persistence based on Kaplan-Meier analysis was 3.0 months. The B-cell reconstitution profiles suggest that obe-cel may induce a reset of pathologic autoimmunity.

Emerging data in the 100M cohort is consistent with the 50M adult cohort, and evaluation is ongoing.

Data support progressing obe-cel as a treatment for srSLE and 50M has been selected as the recommended Phase 2 dose. Autolus has aligned with U.S. Food and Drug Administration (FDA) on a Phase 2 trial design in LN and potential registrational path to approval. The LUMINA trial is now enrolling.

Dr. Christian Itin, Autolus Chief Executive Officer, said: “Obe-cel's safety profile is based on a robust database spanning several clinical trials in B-ALL and B-NHL indications. Data presented today now also show the ability to induce deep depletion of B-cell lineages in patients with srSLE. Obe-cel successfully underwent the regulatory approval process with the FDA, EMA and MHRA in adult r/r B-ALL and launched commercially in the US and UK in 2025. Building on this strong foundation of clinical data, and demonstrated commercial and manufacturing capabilities, we believe Autolus is well positioned for a successful and efficient path into the autoimmune setting.”

About Autolus Therapeutics plc
Autolus Therapeutics plc (Nasdaq: AUTL) is an early commercial-stage biopharmaceutical company developing, manufacturing and delivering next-generation T cell therapies and candidates for the treatment of cancer and autoimmune disease. Using a broad suite of proprietary and modular T cell programming technologies, Autolus is engineering precisely targeted and controlled T cell therapies that are designed to better recognize target cells, break down their defense mechanisms and eliminate these cells. Autolus has a marketed therapy, AUCATZYL®, and a pipeline of product candidates in development for the treatment of hematological malignancies, solid tumors and autoimmune diseases. For more information, please visit www.autolus.com.

About AUCATZYL® (obecabtagene autoleucel, obe-cel)
AUCATZYL is a B-lymphocyte antigen CD19 (CD19) chimeric antigen receptor (CAR) T cell therapy designed to overcome the limitations in clinical activity and safety compared to current CD19 CAR T cell therapies. AUCATZYL is designed with a fast target binding off-rate to minimize excessive activation of the programmed T cells. AUCATZYL was approved by the FDA for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia in 2024, and was granted conditional marketing authorization by the MHRA in the UK and by the EMA in the EU in 2025.

INDICATION
AUCATZYL® is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

IMPORTANT SAFETY INFORMATION

WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, and SECONDARY HEMATOLOGICAL MALIGNANCIES Cytokine Release Syndrome (CRS) occurred in patients receiving AUCATZYL. Do not administer AUCATZYL to patients with active infection or inflammatory disorders. Prior to administering AUCATZYL, ensure that healthcare providers have immediate access to medications and resuscitative equipment to manage CRS. Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), including fatal and life-threatening reactions, occurred in patients receiving AUCATZYL, including concurrently with CRS or after CRS resolution. Monitor for neurologic signs and symptoms after treatment with AUCATZYL. Prior to administering AUCATZYL, ensure that healthcare providers have immediate access to medications and resuscitative equipment to manage neurologic toxicities. Provide supportive care and/or corticosteroids, as needed. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies.

WARNINGS AND PRECAUTIONS

Cytokine Release Syndrome (CRS)
Cytokine Release Syndrome (CRS) occurred following treatment with AUCATZYL. CRS was reported in 75% (75/100) of patients including Grade 3 CRS in 3% of patients. The median time to onset of CRS was 8 days (range: 1 to 23 days) with a median duration of 5 days (range: 1 to 21 days). Sixty-eight percent of patients (51/75) experienced CRS after the first infusion, but prior to the second infusion of AUCATZYL with a median time to onset of 6 days (range: 1 to 10 days). Among patients with CRS, the most common manifestations of CRS included fever (100%), hypotension (35%) and hypoxia (19%). The primary treatment for CRS was tocilizumab (73%; 55/75), with patients also receiving corticosteroids (21%; 16/75).

Prior to administering AUCATZYL, ensure that healthcare providers have immediate access to medications and resuscitative equipment to manage CRS. During and following treatment with AUCATZYL, closely monitor patients for signs and symptoms of CRS daily for at least 7 days following each infusion. Continue to monitor patients for CRS for at least 2 weeks following each infusion with AUCATZYL [see Dosage and Administration]. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time. At the first sign of CRS, immediately evaluate the patient for hospitalization and institute treatment with supportive care based on severity and consider further management per current practice guidelines.

Neurologic Toxicities
Neurologic toxicities including Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS), which were fatal or life-threatening, occurred following treatment with AUCATZYL. Neurologic toxicities were reported in 64% (64/100) of patients, including Grade ≥ 3 in 12% of patients. The median time to onset of neurologic toxicities was 10 days (range: 1 to 246 days) with a median duration of 13 days (range: 1 to 904 days). Among patients with neurologic toxicities, the most common symptoms (> 5%) included ICANS (38%), headache (34%), encephalopathy (33%), dizziness (22%), tremor (13%), anxiety (9%), insomnia (9%), and delirium (8%).

Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS)
ICANS events occurred in 24% (24/100) of patients, including Grade ≥ 3 in 7% (7/100) of patients. Of the 24 patients who experienced ICANS, 33% (8/24) experienced an onset after the first infusion, but prior to the second infusion of AUCATZYL. The median time to onset for ICANS events after the first infusion was 8 days (range: 1 to 10 days) and 6.5 days (range: 2 to 22 days) after the second infusion, with a median duration of 8.5 days (range: 1 to 53 days).

Eighty-eight percent (21/24) of patients received treatment for ICANS. All treated patients received high-dose corticosteroids and 42% (10/24) of patients received anti-epileptics prophylactically. Prior to administering AUCATZYL, ensure that healthcare providers have immediate access to medications and resuscitative equipment to manage ICANS.

Counsel patients to seek medical attention should signs or symptoms of neurologic toxicity/ ICANS occur. At the first sign of Neurologic Toxicity /ICANS, immediately evaluate patients for hospitalization and institute treatment with supportive care based on severity and consider further management per current practice guidelines.

Prolonged Cytopenias
Patients may exhibit cytopenias including anemia, neutropenia, and thrombocytopenia for several weeks after treatment with lymphodepleting chemotherapy and AUCATZYL. In patients who were responders to AUCATZYL, Grade ≥ 3 cytopenias that persisted beyond Day 30 following AUCATZYL infusion were observed in 71% (29/41) of patients and included neutropenia (66%, 27/41) and thrombocytopenia (54%, 22/41). Grade 3 or higher cytopenias that persisted beyond Day 60 following AUCATZYL infusion was observed in 27% (11/41) of patients and included neutropenia (17%, 7/41) and thrombocytopenia (15%, 6/41). Monitor blood counts after AUCATZYL infusion.

Infections
Severe, including life-threatening and fatal infections occurred in patients after AUCATZYL infusion. Non-COVID-19 infections of all grades occurred in 67% (67/100) of patients. Grade 3 or higher non-COVID-19 infections occurred in 41% (41/100) of patients. AUCATZYL should not be administered to patients with clinically significant active systemic infections. Monitor patients for signs and symptoms of infection before and after AUCATZYL infusion and treat appropriately. Administer prophylactic antimicrobials according to local guidelines.

Grade 3 or higher febrile neutropenia was observed in 26% (26/100) of patients after AUCATZYL infusion and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care as medically indicated.

Viral reactivation, potentially severe or life-threatening, can occur in patients treated with drugs directed against B cells. There is no experience with manufacturing AUCATZYL for patients with a positive test for human immunodeficiency virus (HIV) or with active hepatitis B virus (HBV) or active hepatitis C virus (HCV). Perform screening for HBV, HCV and HIV in accordance with clinical guidelines before collection of cells for manufacturing.

Hypogammaglobulinemia
Hypogammaglobulinemia and B-cell aplasia can occur in patients after AUCATZYL infusion. Hypogammaglobulinemia was reported in 10% (10/100) of patients treated with AUCATZYL including Grade 3 events in 2 patients (2%).

Immunoglobulin levels should be monitored after treatment with AUCATZYL and managed per institutional guidelines including infection precautions, antibiotic or antiviral prophylaxis, and immunoglobulin replacement.

The safety of immunization with live viral vaccines during or following treatment with AUCATZYL has not been studied. Vaccination with live viral vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy treatment, during AUCATZYL treatment, and until immune recovery following treatment with AUCATZYL.

Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS)
HLH/MAS including fatal and life-threatening reactions occurred after treatment with AUCATZYL. HLH/MAS was reported in 2% (2/100) of patients and included Grade 3 and Grade 4 events with a time of onset at Day 22 and Day 41, respectively. One patient experienced a concurrent ICANS events after AUCATZYL infusion and died due to sepsis with ongoing HLH/MAS that had not resolved. Administer treatment for HLH/MAS according to institutional standards.

Hypersensitivity Reactions
Serious hypersensitivity reactions, including anaphylaxis, may occur due to dimethyl sulfoxide (DMSO), an excipient used in AUCATZYL. Observe patients for hypersensitivity reactions during and after AUCATZYL infusion.

Secondary Malignancies
Patients treated with AUCATZYL may develop secondary malignancies. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies. Mature T cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusion, and may include fatal outcomes. Monitor lifelong for secondary malignancies.

Adverse Reactions
The safety of AUCATZYL was evaluated in the FELIX study in which 100 patients with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL) received AUCATZYL at a median dose of 410 × 10⁶ CD19 CAR-positive viable T cells (range: 10 to 480 × 10⁶ CD19 CAR-positive viable T cells with 90% of patients receiving the recommended dose of 410 × 10⁶ +/- 25%).

The most common serious adverse reactions of any Grade (incidence ≥ 2%) included infections-pathogen unspecified, febrile neutropenia, ICANS, CRS, fever, bacterial infectious disorders, encephalopathy, fungal infections, hemorrhage, respiratory failure, hypotension, ascites, HLH/MAS, thrombosis and hypoxia. Nine patients (9%) experienced fatal adverse reactions which included infections (sepsis, pneumonia, peritonitis), ascites, pulmonary embolism, acute respiratory distress syndrome, HLH/MAS and ICANS. Of the 9 patients, five patients who died from infections had pre-existing and ongoing neutropenia prior to receiving bridging therapy, lymphodepletion chemotherapy treatment and/or AUCATZYL.

Please see full Prescribing Information, including BOXED WARNING and Medication Guide.

Forward-Looking Statements   
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, and in some cases can be identified by terms such as "may," "will," "could," "expects," "plans," "anticipates," and "believes." These statements include, but are not limited to, statements regarding the therapeutic potential and expected clinical benefits of obecabtagene autoleucel (obe-cel); the period during which the results of clinical studies or trials will become available; the timing or likelihood of regulatory filings and approvals for product candidates, along with regulatory developments in the US, EU, the UK and other foreign countries. Any forward-looking statements are based on management's current views and assumptions and involve risks and uncertainties that could cause actual results, performance, or events to differ materially from those expressed or implied in such statements. These risks and uncertainties include, but are not limited to, the risks that the impact of worsening macroeconomic conditions on Autolus’ business, financial position, strategy and anticipated milestones, including Autolus’ ability to conduct ongoing and planned clinical trials; Autolus’ ability to obtain a clinical supply of current or future product candidates; the delay of any current or planned clinical trials, whether due to patient enrollment delays or otherwise; Autolus’ ability to successfully demonstrate the safety and efficacy of its product candidates and gain approval of its product candidates on a timely basis, if at all; competition with respect to market opportunities; the risk that Autolus’ preclinical or clinical programs do not advance or result in approved products on a timely or cost effective basis or at all; the results of early clinical trials are not always being predictive of future results; the cost, timing and results of clinical trials; that many product candidates do not become approved drugs on a timely or cost effective basis or at all; and possible safety and efficacy concerns. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Autolus’ actual results to differ from those contained in the forward-looking statements, see the section titled "Risk Factors" in Autolus' Annual Report on Form 10-K filed with the Securities and Exchange Commission, or the SEC, on March 20, 2025 as well as discussions of potential risks, uncertainties, and other important factors in Autolus' subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Autolus undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required by law. You should, therefore, not rely on these forward-looking statements as representing Autolus’ views as of any date subsequent to the date of this press release. 

Contact:

Amanda Cray 
+1 617-967-0207 
a.cray@autolus.com 

FAQ

What were the CARLYSLE topline results for Autolus (AUTL) at ASH Dec 8, 2025?

Nine adults were infused; at 50M dose CRR 50% and DORIS 83% were reported with median DORIS onset 5.1 months and median follow-up 12 months.

What safety signals did Autolus report for obe-cel in the CARLYSLE trial (AUTL)?

No DLTs at 50M, no ICANS; Grade 1 CRS occurred in three patients at 50M and three at 100M; one transient Grade 3 liver toxicity in 100M cohort; hypertension noted in five 50M patients.

What dose will Autolus (AUTL) use in Phase 2 for lupus nephritis and is the trial enrolling?

The company selected the 50×10^6 cell dose as the recommended Phase 2 dose and the LUMINA Phase 2 trial is now enrolling.

How durable were responses and what is CAR T persistence in the CARLYSLE data for AUTL?

Median time to loss of CAR T-cell persistence was 3.0 months; DORIS responses had median onset of 5.1 months with no new disease activity at median 12 months follow-up in the 50M cohort.

How many patients received the 100×10^6 dose in CARLYSLE and are 100M results mature?

Three adults received the 100×10^6 dose and data are described as initial/emerging with ongoing evaluation.