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OncoMatch/Clinical Trials/NCT05798897

Safety and Preliminary Efficacy of MT-601 in Patients With Relapsed/Refractory Lymphoma

Is NCT05798897 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies MT-601 for non-hodgkin lymphoma, adult.

Phase 1RecruitingMarker Therapeutics, Inc.NCT05798897Data as of Jun 2026

Treatment: MT-601This study is a Phase 1 multicenter study with a Dose Escalation and Dose Expansion evaluating safety and efficacy of MT-601 administration to patients with Relapsed or Refractory Lymphoma. The starting dose administered is 200 x 10\^6 cells (flat dosing).

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Extracted eligibility criteria

Treatments studied

Other

MT-601

Cancer type

Hodgkin Lymphoma

Non-Hodgkin Lymphoma

Performance status

KARNOFSKY/ECOG 0–1

Karnofsky score of ≥70 or performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale

Demographics

Ages ≤ 100

Prior therapy

Min 2 prior lines

Cannot have received: allogeneic hematopoietic cell transplant

Receipt of allogeneic hematopoietic cell transplant (HCT) within 12 months; on immunosuppression or with evidence of donor/mixed chimera

Cannot have received: autologous hematopoietic cell transplant

Receipt of autologous HCT within 3 months

Cannot have received: CD19-directed CAR T cell therapy

Treatment with CD19-directed CAR T cell therapy within 3 months

Cannot have received: bispecific antibody

Treatment with bispecific antibody within 1 month

Cannot have received: antibody-drug conjugate

Treatment with antibody drug conjugates (ADC's) or PD-1/PD-L1 within 21 days

Cannot have received: anti-PD-1 therapy

Treatment with antibody drug conjugates (ADC's) or PD-1/PD-L1 within 21 days

Cannot have received: anti-PD-L1 therapy

Treatment with antibody drug conjugates (ADC's) or PD-1/PD-L1 within 21 days

Cannot have received: monoclonal antibodies impacting T cell function

Treatment with monoclonal antibodies impacting T cell function within 14 days

Cannot have received: systemic immunosuppression (systemic corticosteroids)

Exception: unless ≤5 mg/day oral prednisone or steroid equivalent

Treatment with systemic immunosuppression including systemic corticosteroids (unless ≤5 mg/day oral prednisone or steroid equivalent) within 14 days

Cannot have received: chemotherapy

Treatment with chemotherapy within 7 days

Cannot have received: live, attenuated vaccine

Treatment with a live, attenuated vaccine within 4 weeks

Cannot have received: antibody-drug conjugate

Treatment with antibody drug conjugates (ADC's) or PD-1/PD-L1 within 21 days

Cannot have received: anti-PD-1 therapy

Treatment with antibody drug conjugates (ADC's) or PD-1/PD-L1 within 21 days

Cannot have received: anti-PD-L1 therapy

Treatment with antibody drug conjugates (ADC's) or PD-1/PD-L1 within 21 days

Cannot have received: chemotherapy

Treatment with chemotherapy or biologics/monoclonal antibodies within 14 days

Cannot have received: biologics/monoclonal antibodies

Treatment with chemotherapy or biologics/monoclonal antibodies within 14 days

Cannot have received: radiation therapy

Treatment with radiation therapy within 7 days

Cannot have received: tyrosine kinase inhibitor

Treatment with a tyrosine kinase inhibitor (TKI) within 7 days or 5 half-lives (whichever is longer) before conditioning regimen

Cannot have received: hematopoietic growth factors

Hematopoietic growth factors <2 days

Cannot have received: experimental CAR T cell product

Exception: unless approved by Medical Monitor

Treatment with experimental CAR T cell product unless approved by Medical Monitor

Cannot have received: other cancer therapy including investigational agents

Treatment with other cancer therapy including investigational agents that do not fit in the above categories within 14 days

Cannot have received: major surgery

Major surgery within 14 days

Lab requirements

Blood counts

Hemoglobin ≥ 7.0 g/dL (can be transfused), ALC ≥ 300/μL (prior to apheresis only), ANC ≥ 750/μL and platelet count ≥ 50,000/μL (prior to the conditioning regimen only)

Kidney function

Serum creatinine ≤ 1.5X ULN or measured or calculated creatinine clearance ≥ 50 mL/min (prior to the conditioning regimen)

Liver function

Bilirubin ≤ 1.5X ULN (exception of bilirubin elevation due to Gilbert's syndrome 3X); AST and ALT ≤ 3X ULN

Cardiac function

left ventricular ejection fraction ≥ 45% (prior to the leukapheresis)

Adequate blood, liver, renal and cardiac function: Hemoglobin ≥ 7.0 g/dL (can be transfused), ALC ≥ 300/μL (prior to apheresis only), ANC ≥ 750/μL and platelet count ≥ 50,000/μL (prior to the conditioning regimen only); Bilirubin ≤ 1.5X ULN (exception of bilirubin elevation due to Gilbert's syndrome 3X); AST and ALT ≤ 3X ULN; Serum creatinine ≤ 1.5X ULN or measured or calculated creatinine clearance ≥ 50 mL/min (prior to the conditioning regimen); left ventricular ejection fraction ≥ 45% (prior to the leukapheresis)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • City of Hope · Duarte, California
  • University of Colorado · Aurora, Colorado
  • Colorado Blood Cancer Institute (Sarah Cannon) · Denver, Colorado
  • University of Kansas Medical Center · Kansas City, Kansas
  • Cornell · New York, New York

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT05798897 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior allogeneic hematopoietic cell transplant, autologous hematopoietic cell transplant, CD19-directed CAR T cell therapy disqualifies patients from enrollment.

Is there an age limit?

Yes. Patients must be 100 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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