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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 (May 2026). This Phase 1 trial studies MT-601 for non-hodgkin lymphoma, adult.

Phase 1RecruitingMarker Therapeutics, Inc.NCT05798897Data as of May 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

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

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 →

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