Cullinan Therapeutics Highlights Fourth Quarter 2026 Milestones Across Immunology and Oncology T Cell Engager Portfolio

The planned data updates span autoimmune diseases and relapsed or refractory acute myeloid leukemia.

Rhea-AI Summary

Cullinan Therapeutics (CGEM) outlined fourth-quarter 2026 data updates for three investigational T cell engager programs on September 24, 2026.

In December, Cullinan plans to report multi-dose and single target dose regimen data for CLN-978 in systemic lupus erythematosus, rheumatoid arthritis and Sjögren’s disease. Multi-dose regimen data for velinotamig in lupus, from an ongoing Genrix Bio Phase 1 dose escalation study, are scheduled for a November 8 poster session at ACR Convergence 2026. Updated data from the dose escalation portion of the Phase 1 CLN-049 study in relapsed or refractory acute myeloid leukemia are planned for December. Cullinan also plans to initiate a potentially registrational Phase 2 study of CLN-049 following a recent FDA meeting.

Key Figures

Velinotamig data presentation: November 8, 2026 CLN-978 data update: December 2026 CLN-049 data update: December 2026

Velinotamig data presentation

November 8, 2026

Multi-dose regimen data in SLE scheduled for an ACR Convergence poster session

CLN-978 data update

December 2026

Multi-dose and single target dose regimen data in SLE, RA and Sjögren’s disease

CLN-049 data update

December 2026

Updated data from the Phase 1 dose escalation study

Key Terms

t cell engager, sle, aml, dose escalation

4 terms

t cell engager technical

"We look forward to providing several updates across our T cell engager programs"

A T cell engager is an engineered protein drug that physically links a patient’s T cell — the immune system’s attack cell — to a diseased cell so the T cell will recognize and kill it. For investors it matters because clinical trial results, manufacturing success and safety profiles determine whether the therapy becomes a widely adopted, high-value treatment or a costly failure; think of it like a matchmaker that must reliably bring soldiers to the right target without triggering friendly fire.

sle medical

"treatment-refractory moderate to severe systemic lupus erythematosus (SLE)"

Systemic lupus erythematosus is a chronic autoimmune disease in which the body's defense system mistakenly attacks healthy tissues, causing inflammation in the skin, joints, kidneys, blood and other organs — like a home alarm that repeatedly sounds for harmless activity. For investors, SLE matters because it defines a sizable, often under-served medical market; clinical trial results, regulatory approvals, and new therapies can drive significant revenue shifts and alter the valuations of companies developing treatments.

aml medical

"relapsed/refractory AML patients"

AML stands for anti-money laundering — the laws, rules and internal checks that banks and businesses use to spot and stop illicit cash flows, such as proceeds from crime or funding of illegal activities. Think of it as a security checkpoint for money: investors care because poor AML controls can lead to heavy fines, frozen assets and reputational harm that hurt profits and share value, while strong controls reduce legal and operational risk.

dose escalation medical

"longer follow up from the dose escalation portion of our ongoing Phase 1 study"

Dose escalation is the process of gradually increasing the amount of a treatment or substance over time. In finance, it can refer to slowly raising investments or commitments to manage risk and assess performance. For investors, understanding dose escalation helps gauge how companies or strategies adjust their approaches, which can impact future growth or stability.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Velinotamig (BCMA TCE) multi-dose regimen data in SLE at ACR Convergence 2026 in November 

CLN-978 (CD19 TCE) multi-dose regimen data in SLE, RA and Sjögren’s disease in December

CLN-049 (FLT3 TCE) updated data from the Phase 1 dose escalation study in December

CAMBRIDGE, Mass., Sept. 24, 2026 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM; “Cullinan”), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, disease-modifying T cell engagers in autoimmune diseases and cancer, today outlined fourth quarter 2026 milestones across its immunology and oncology pipeline.

“We look forward to providing several updates across our T cell engager programs in the fourth quarter of 2026. Starting with autoimmune diseases, for CLN-978 we look forward to sharing the most comprehensive clinical data set to date for a CD19 T cell engager across all indications, with multi-dose regimen data reported concurrently for SLE, RA, and now Sjögren’s disease also. For velinotamig, we will provide multi-dose regimen data from the ongoing Phase 1 dose escalation study as we advance the program in plasma cell driven diseases. Together, our CD19- and BCMA-targeted programs reflect a differentiated approach to treating autoimmune diseases, aiming to address distinct disease drivers across a broad range of conditions. For CLN-049, we plan to provide an update with longer follow up from the dose escalation portion of our ongoing Phase 1 study in a broad, all-comer population of relapsed/refractory AML patients. We look forward to rapidly progressing this program and initiating our potentially registrational Phase 2 study, following our recent successful meeting with the FDA,” said Nadim Ahmed, President and CEO of Cullinan Therapeutics.

The Company plans to share the following immunology and oncology pipeline updates in Q4 2026:

• CLN-978 (CD19xCD3 T cell engager): treatment-refractory moderate to severe systemic lupus erythematosus (SLE), difficult-to-treat rheumatoid arthritis (RA), and treatment-refractory moderate to severe Sjögren’s disease (SjD)
  • Multi-dose and single target dose regimen data in SLE, RA, and SjD in December

• Velinotamig (BCMAxCD3 T cell engager): treatment-refractory autoimmune diseases driven by long-lived plasma cells
  • Multi-dose regimen data from the ongoing Genrix Bio Phase 1 dose escalation study in SLE to be shared in poster session at ACR Convergence 2026 on November 8, 2026, 10:30 a.m. to 12:30 p.m. ET

• CLN-049 (FLT3xCD3 T cell engager): relapsed/refractory acute myeloid leukemia (AML)
  • Updated data from the dose escalation portion of the Phase 1 study in December
    
    

About Cullinan Therapeutics

Cullinan Therapeutics, Inc. (Nasdaq: CGEM) is a biopharmaceutical company developing potential first- or best-in-class, disease-modifying T cell engagers for autoimmune diseases and cancer. Cullinan pursues promising therapeutic targets while leveraging core expertise in T cell engagers, which are established in oncology and are now advancing into autoimmune diseases. With a clinical-stage pipeline built on a rigorous scientific approach and purposeful innovation, Cullinan is advancing its mission to deliver new standards of care for patients. Learn more about Cullinan at https://cullinantherapeutics.com/, and follow Cullinan on LinkedIn and X.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements regarding the company’s beliefs and expectations regarding: our clinical development plans and anticipated timelines for our product candidates, the clinical and therapeutic potential of our product candidates, our plans regarding future data presentations and other statements that are not historical facts. The words “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “plan,” “potential,” “project,” “pursue,” “will,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

Any forward-looking statements in this press release are based on management's current expectations and beliefs of future events and are subject to known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks include, but are not limited to, the following: uncertainty regarding the timing and results of clinical trial data and regulatory submissions; the risk that any NDAs, INDs, or other global regulatory submissions we may file with the United States Food and Drug Administration or other global regulatory agencies are not accepted or cleared on our expected timelines, or at all; the success of our clinical trials and preclinical studies; the risks related to our ability to protect and maintain our intellectual property position; the risks related to manufacturing, supply, and distribution of our product candidates; the risk that any one or more of our product candidates, including those that are co-developed, will not be successfully developed and commercialized; the risk that the results of preclinical studies or clinical trials will not be predictive of future results in connection with future studies or clinical trials; the effect of changes in global economic conditions, including uncertainties related to international trade policies, tariffs and supply chain dynamics on our business and operations; and the success of any collaboration, partnership, license or similar agreements. These and other important risks and uncertainties discussed in our filings with the Securities and Exchange Commission, including under the caption “Risk Factors” in our most recent Annual Report on Form 10-K and subsequent filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change, except to the extent required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Moreover, except as required by law, neither the company nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statement included in this press release speaks only as of the date on which it was made.

Contacts:

Investors
Nick Smith
+1 401.241.3516
nsmith@cullinantx.com

Media 
Rose Weldon
+1 215.801.7644
rweldon@cullinantx.com

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What CLN-978 data does Cullinan Therapeutics plan to report in December 2026?

Cullinan plans to report multi-dose and single target dose regimen data for CLN-978 in systemic lupus erythematosus, rheumatoid arthritis and Sjögren’s disease.