Marker Therapeutics Provides Update on Phase 1 APOLLO Study Highlighting Encouraging Overall Response Rates in Relapsed Lymphoma
Marker Therapeutics (NASDAQ:MRKR) has reported encouraging results from its Phase 1 APOLLO study investigating MT-601, a Multi-Antigen Recognizing T cell product, for treating relapsed lymphoma. The study demonstrated a 66% objective response rate in Non-Hodgkin Lymphoma (NHL) patients, with 50% achieving complete response.
The trial included 24 B-cell lymphoma patients across 7 U.S. clinical sites, with doses ranging from 100x106–400x106 cells. Notable outcomes include 78% objective response rate in Hodgkin Lymphoma patients and durable responses lasting 3-24 months. The treatment showed a favorable safety profile with no dose-limiting toxicities or serious adverse events.
The company is advancing to the dose expansion phase, investigating MT-601 at the maximum dose of 400x106 cells in DLBCL patients who have relapsed after or are ineligible for CAR-T therapy.
Marker Therapeutics (NASDAQ:MRKR) ha reso noti risultati promettenti dallo studio di Fase 1 APOLLO su MT-601, un trattamento con cellule T in grado di riconoscere più antigeni, per linfomi recidivati. Lo studio ha mostrato un 66% di tasso di risposta obiettiva nei pazienti con linfoma non-Hodgkin (NHL), di cui il 50% con risposta completa.
Il trial ha arruolato 24 pazienti con linfoma B in 7 centri clinici negli USA, con dosi comprese tra 100x10^6 e 400x10^6 cellule. Risultati degni di nota includono un 78% di tasso di risposta obiettiva nei pazienti con linfoma di Hodgkin e risposte durature da 3 a 24 mesi. Il profilo di sicurezza è risultato favorevole, senza tossicità dose-limitante né eventi avversi gravi.
L'azienda sta ora passando alla fase di espansione della dose, valutando MT-601 alla dose massima di 400x10^6 cellule nei pazienti con DLBCL recidivato dopo, o non eleggibile per, la terapia CAR-T.
Marker Therapeutics (NASDAQ:MRKR) ha comunicado resultados alentadores del estudio de Fase 1 APOLLO con MT-601, un producto de células T que reconoce múltiples antígenos, para el tratamiento de linfomas recidivantes. El estudio mostró una tasa de respuesta objetiva del 66% en pacientes con linfoma no Hodgkin (NHL), con un 50% logrando respuesta completa.
El ensayo incluyó a 24 pacientes con linfoma B en 7 centros clínicos de EE. UU., con dosis entre 100x10^6 y 400x10^6 células. Resultados destacados incluyen una tasa de respuesta objetiva del 78% en pacientes con linfoma de Hodgkin y respuestas duraderas de 3 a 24 meses. El tratamiento mostró un perfil de seguridad favorable sin toxicidades limitantes de dosis ni eventos adversos graves.
La compañía avanza a la fase de expansión de dosis, investigando MT-601 en la dosis máxima de 400x10^6 células en pacientes con DLBCL que han recaído después de, o no son elegibles para, la terapia CAR-T.
Marker Therapeutics (NASDAQ:MRKR)는 재발성 림프종 치료를 위한 다중 항원 인식 T세포 제제 MT-601을 평가한 1상 APOLLO 연구에서 고무적인 결과를 발표했습니다. 연구에서 비호지킨 림프종(NHL) 환자들의 객관적 반응률이 66%, 그중 50%가 완전 관해를 보였습니다.
시험에는 미국 내 7개 임상기관에서 24명의 B세포 림프종 환자가 참여했으며, 투여 용량은 100x10^6–400x10^6 세포였습니다. 주목할 점으로는 호지킨 림프종 환자의 객관적 반응률이 78%였고, 반응은 3~24개월 동안 지속되었습니다. 용량 제한 독성이나 중대한 이상반응 없이 안전성 프로필도 양호했습니다.
회사는 용량 확장 단계로 진입하여, CAR-T 치료 후 재발했거나 CAR-T 적응증이 아닌 DLBCL 환자들을 대상으로 최대 용량인 400x10^6 세포의 MT-601을 조사할 예정입니다.
Marker Therapeutics (NASDAQ:MRKR) a annoncé des résultats encourageants de l'étude de phase 1 APOLLO évaluant MT‑601, un produit de lymphocytes T reconnaissant plusieurs antigènes, pour le traitement des lymphomes en rechute. L'étude a montré un taux de réponse objective de 66% chez les patients atteints de lymphome non hodgkinien (LNH), dont 50% ont obtenu une réponse complète.
L'essai a inclus 24 patients atteints de lymphome B répartis dans 7 centres cliniques aux États‑Unis, avec des doses allant de 100x10^6 à 400x10^6 cellules. Parmi les résultats notables figurent un taux de réponse objective de 78% chez les patients atteints de lymphome de Hodgkin et des réponses durables de 3 à 24 mois. Le profil de sécurité était favorable, sans toxicités limitantes de dose ni événements indésirables graves.
La société passe maintenant à la phase d'expansion de dose, évaluant MT‑601 à la dose maximale de 400x10^6 cellules chez des patients atteints de DLBCL rechutés après une thérapie CAR‑T ou non éligibles à celle‑ci.
Marker Therapeutics (NASDAQ:MRKR) hat ermutigende Ergebnisse der Phase‑1‑Studie APOLLO zu MT‑601, einem multiantigen-erkennenden T‑Zellen‑Produkt, bei rezidiviertem Lymphom berichtet. Die Studie zeigte eine objektive Ansprechrate von 66% bei Patienten mit Non‑Hodgkin‑Lymphom (NHL), davon erreichten 50% ein komplettes Ansprechen.
Die Studie umfasste 24 B‑Zell‑Lymphom‑Patienten an 7 US‑Klinikstandorten mit Dosen von 100x10^6–400x10^6 Zellen. Bemerkenswerte Ergebnisse sind eine objektive Ansprechrate von 78% bei Hodgkin‑Lymphom‑Patienten und anhaltende Ansprechen von 3–24 Monaten. Das Sicherheitsprofil war günstig, ohne dosislimitierende Toxizitäten oder schwerwiegende Nebenwirkungen.
Das Unternehmen geht nun in die Dosis‑Erweiterungsphase und untersucht MT‑601 in der Höchstdosis von 400x10^6 Zellen bei DLBCL‑Patienten, die nach einer CAR‑T‑Therapie rückfällig geworden sind oder für diese nicht infrage kommen.
- 66% objective response rate in NHL patients with 50% complete response rate
- 78% objective response rate in Hodgkin Lymphoma patients
- Durable responses observed up to 24 months with 5 patients showing continued response ≥6 months
- Favorable safety profile with no dose-limiting toxicities or serious adverse events
- Successfully cleared maximum dose (400x106 cells) for dose expansion phase
- Only 1 complete response (11%) achieved in Hodgkin Lymphoma patients
- Two reported Grade 1 cytokine release syndrome events
Insights
Marker's MT-601 shows promising 66% response rate in heavily pre-treated lymphoma patients with excellent safety profile, addressing critical unmet need.
The Phase 1 APOLLO study results for Marker Therapeutics' Multi-Antigen Recognizing T cell therapy (MT-601) represent a potentially significant advancement in treating relapsed lymphoma patients. The 66% objective response rate with 50% complete responses in Non-Hodgkin Lymphoma (NHL) patients is particularly notable given these patients had received a median of 5 prior lines of therapy, including CAR-T cells and bispecific antibodies.
What makes these results clinically meaningful is the durability of responses - ranging from 3-24 months with 5 patients maintaining response beyond 6 months and 3 patients beyond 12 months. This suggests MT-601 may provide lasting benefit in a population with few remaining options. The efficacy extends beyond NHL, with 78% objective response rate in heavily pre-treated Hodgkin Lymphoma patients (median 8 prior therapies).
The safety profile is remarkably clean for a cell therapy. No dose-limiting toxicities were observed even at the highest dose level (400x106 cells). Most importantly, there were no cases of immune-effector cell associated neurotoxicity syndrome (ICANS) - a serious complication that affects approximately 20-30
The dose expansion phase investigating the maximum 400x106 cell dose in DLBCL patients could potentially improve upon these already encouraging results. This therapy addresses a critical unmet need for the 40-60
Ongoing Phase 1 APOLLO study investigating MT-601 in patients with relapsed B cell lymphoma showed
Favorable safety profile observed in study participants with no dose limiting toxicities (DLTs) or immune-effector cell associated neurotoxicity syndrome (ICANS) in the dose escalation cohort
Dose expansion phase of study will investigate MT-601 at pre-specified maximum dose in patients with Diffuse Large B Cell Lymphoma (DLBCL) who have relapsed after or are ineligible for chimeric antigen receptor (CAR)-T cell therapy
Live Webcast to be held today to discuss results at 8:30 a.m. ET
HOUSTON, Aug. 26, 2025 (GLOBE NEWSWIRE) -- Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company focusing on developing next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, today provided an update on the progress and clinical observations from the Phase 1 APOLLO study.
The Company’s Phase 1 APOLLO study (clinicaltrials.gov identifier: NCT05798897) is a multicenter, open-label clinical study investigating MT-601, a Multi-Antigen Recognizing (MAR)-T cell product, in patients with lymphoma who have relapsed after anti-CD19 CAR-T cell therapy or for whom anti-CD19 CAR-T cell therapy is not an option. Today, Marker is reporting an update on the safety and efficacy data from the dose escalation portion of the study showing a favorable safety profile across all evaluated doses (dose range 100x106–400x106 cells) and a
A total of 24 B-cell lymphoma patients have been treated with MT-601 across 7 U.S. clinical sites, including 15 patients with Non-Hodgkin Lymphoma (NHL) and 9 patients with Hodgkin Lymphoma (HL). At the time of the data cutoff (June 2025), 12 NHL and 9 HL patients have been assessed. Patients with NHL and HL received doses ranging from 100x106–400x106 cells and showed objective responses and a favorable safety profile.
“We are very excited and encouraged by the progress of the study,” said Juan Vera, M.D., President and CEO of Marker Therapeutics. “The safety and preliminary efficacy data from our Phase 1 APOLLO study underscore the potential of MT-601 in heavily pre-treated patients with lymphoma, who have relapsed after multiple lines of therapy, including CAR-T cells and bispecific antibodies. While CAR-T cells have gained acceptance in the treatment of lymphoma, with approximately 8,000 patients treated globally in 2024, 40
Efficacy and Duration of Response
The 12 NHL patients received doses ranging from 100x106–200x106 cells and had undergone multiple lines of therapy (median of 5 prior lines of therapy), including anti-CD19 CAR-T cells (n=9) and bispecific antibodies (n=4); dual exposed patients (n=4). 8 out of 12 NHL patients had objective responses (
HL patients received doses ranging from 200x106–400x106 cells and had undergone a median of 8 prior lines of therapy. Seven out of 9 HL patients had objective responses (
Safety Profile
The dose escalation portion of the study tested doses ranging from 100x106–400x106 cells in patients with B-cell lymphoma. To date, no DLTs have been reported at the highest dose (400x106 cells). Infusion of MT-601 was well tolerated in all study participants, with no observation of ICANS and two reported Grade 1 cytokine release syndrome (CRS) events (fever; no treatment was required). Patients were treated with or without lymphodepleting chemotherapy prior to receiving infusions of MT-601. No change in DLTs or ICANS was observed between patients treated with and without lymphodepletion. Data collected from the 24 patients treated demonstrated a robust safety profile with no reported serious adverse events reinforcing the benefit of MT-601.
Study Design and Dose Expansion
The Phase 1 APOLLO study is composed of a dose escalation phase, followed by a dose expansion phase. The dose escalation cohort evaluated the safety and optimum dose level of MT-601 with doses ranging from 100x106–400x106 cells. On June 17, the Safety Review Committee (SRC) cleared the pre-specified maximum dose (400x106 cells) for the dose expansion portion of the trial. The dose expansion will enroll patients with DLBCL who have relapsed after anti-CD19 CAR-T cells or who are ineligible for CAR-T therapy.
“The observed outcomes in NHL demonstrate that certain patients can achieve clinically meaningful responses with MT-601 even at lower doses of 100x106 or 200x106 cells,” commented Dr. Vera. “We look forward to advancing the study to the dose expansion phase, where we will investigate MT-601 at the maximum dose of 400x106 cells in patients with relapsed DLBCL to potentially build upon these promising results.”
Dr. Vera continued, “The encouraging efficacy in patients with NHL was achieved at doses ranging from 100x106–200x106 cells. We believe that investigating MT-601 at the maximum dose of 400x106 cells in the dose expansion cohort could have the potential to further improve the clinical efficacy and durability we are currently observing in patients with NHL. It is particularly encouraging that even at the highest dose level no DLTs were reported in the dose escalation phase. We will continue to closely monitor the safety and efficacy of MT-601 in treated patients and anticipate to provide another data update in the first half of 2026.”
Webcast Details
Marker will host a live, online-only webcast today at 8:30 am E.D.T. to discuss the clinical results and provide a corporate update. To attend the live event, please use this link to register. During the event, attendees will have the opportunity to submit written questions via the webcast platform’s Q&A feature. After the event, a recording will be made available for replay on the Company’s IR website under Events & Presentations for approximately 30 days.
About MT-601
The Company’s lead product, MT-601, is a multi-antigen recognizing (MAR) T cell product that utilizes a non-genetically modified approach that specifically targets six different tumor antigens upregulated in lymphoma cells (Survivin, PRAME, WT-1, NY-ESO-1, SSX-2, MAGEA-4). Marker is currently investigating MT-601 in the Company-sponsored Phase 1 APOLLO trial (clinicaltrials.gov identifier: NCT05798897) for the treatment of patients with lymphoma who have relapsed after or are not candidates for anti-CD19 CAR-T cell therapies.
About APOLLO
The APOLLO trial (clinicaltrials.gov Identifier: NCT05798897) is a Phase 1, multicenter, open-label study designed to evaluate the safety and efficacy of MT-601 in participants with relapsed or refractory lymphoma who have either failed anti-CD19 chimeric antigen receptor (CAR) T cell therapy or are not candidates for anti-CD19 CAR-T cell therapy. The primary objective of this exploratory Phase 1 clinical trial is to evaluate the optimum dose, safety, and preliminary efficacy of MT-601 in participants with various lymphoma subtypes. The APOLLO study is supported by the National Cancer Institute of the National Institutes of Health under Award Number R44CA291521.
About MAR-T cells
The multi-antigen recognizing (MAR) T cell platform (formerly known as multiTAA-specific T cells) is a novel, non-genetically modified cell therapy approach that selectively expands tumor-specific T cells from a patient's/donor’s blood capable of recognizing a broad range of tumor antigens. Unlike other T cell therapies, MAR-T cells allow the recognition of hundreds of different epitopes within up to six tumor-specific antigens, thereby reducing the possibility of tumor escape. Since MAR-T cells are not genetically engineered, Marker believes that its product candidates will be easier and less expensive to manufacture, with an improved safety profile compared to current engineered T cell approaches and may provide patients with meaningful clinical benefits.
About Marker Therapeutics, Inc.
Marker Therapeutics, Inc. is a Houston, TX-based clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumors. The Company was founded at Baylor College of Medicine, and clinical trials that enrolled more than 200 patients across various hematological and solid tumor indications showed that the Company’s autologous and allogeneic MAR-T cell products were well tolerated and demonstrated durable clinical responses. Marker’s goal is to introduce novel T cell therapies to the market and improve patient outcomes. To achieve these objectives, the Company prioritizes the preservation of financial resources and focuses on operational excellence. Marker’s unique T cell platform is strengthened by non-dilutive funding from U.S. state and federal agencies supporting cancer research.
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Forward-Looking Statements
This release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements in this news release concerning the Company’s expectations, plans, business outlook or future performance, and any other statements concerning assumptions made or expectations as to any future events, conditions, performance or other matters, are “forward-looking statements.” Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: our research, development and regulatory activities and expectations relating to our non-engineered multi-tumor antigen specific T cell therapies; the effectiveness of these programs or the possible range of application and potential curative effects and safety in the treatment of diseases; and the timing, conduct, interim results announcements and outcomes of our clinical trials of our product candidates, including MT-601 for the treatment of patients with lymphoma. Forward-looking statements are by their nature subject to risks, uncertainties and other factors which could cause actual results to differ materially from those stated in such statements. Such risks, uncertainties and factors include, but are not limited to the risks set forth in the Company’s most recent Form 10-K, 10-Q and other SEC filings which are available through EDGAR at WWW.SEC.GOV. The Company assumes no obligation to update its forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release except as may be required by law.
Media and Investor Contact
Marker Therapeutics, Inc.
+1 (713) 400-6400
investor.relations@markertherapeutics.com
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