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

• Status: Recruiting
• Trial end date: 2028-02-28
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Marker Therapeutics, Inc.

Criteria

Inclusion Criteria:

• All applicable inclusion and exclusion criteria must be met at Screening and at Baseline (re-assessment of eligibility within 14 days prior to group assignment).

Patients are eligible to be included in the study only if all of the following criteria apply and the patient, in the judgement of the Investigator, is an appropriate candidate for experimental therapy:

1. Cytologically or histologically confirmed diagnosis of Non-Hodgkin Lymphoma (in any subtype where CD19+ T cell therapy is approved, e.g., DLBCL, MCL, FL)

2. Relapsed or refractory to CD19+ CAR T cell therapy or ineligible for CD19+ CAR T cell therapy (includes patients whose BOR of SD following CD19+ CAR T cell therapy).

3. Patients who have had only BOR of PR to CD19+ CAR T cell therapy may also enroll

4. Are ≥18 years of age prior to administration of MT-601

5. Patients must have patient-derived cells available to make MT-601

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

7. Life expectancy ≥12 weeks

8. Adequate blood, liver, and renal function

1. Blood: Hemoglobin ≥7.0 g/dL (can be transfused)

2. Liver: Bilirubin ≤1.5X upper limit of normal (ULN) (exception of bilirubin elevation due to Gilbert's syndrome); aspartate aminotransferase ≤3X ULN

3. Renal: Serum creatinine ≤2X ULN or measured or calculated creatinine clearance ≥30mL/min

9. Sexually active patients must be willing to utilize one of the highly effective birth control methods or practice complete abstinence starting from Screening for T cell infusion until 6 months after the last T cell infusion. Male patients who are sexually active must agree to use a condom during this period

10. At least 4 half-lives or 1 week has passed after administration of prior therapy or bridging therapy

11. Dose escalation defined as patients whose prior treatment course does not meet precise eligibility criteria but may still be approved upon review by the Sponsor

Exclusion Criteria:

• Patients are excluded from the study if any of the following criteria apply:

1. Clinically significant or severely symptomatic intercurrent infection (e.g. patients with uncontrolled HIV infection or have active HBV/HCV infection)

2. Pregnant or lactating

3. Any other issue which, in the opinion of the treating physician, would make the patient ineligible for the study

4. Taking systemic corticosteroids (exception: physiological doses of steroids allowed)

5. Autologous or allogeneic HSCT within 1 month