Clinical Trial 20484

Cancer Type: Malignant Hematology
Study Type: Treatment
NCT#: NCT04511130

Phase: Phase II
Principal Investigator: Bejanyan, Nelli

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Overview

Study Title

A Phase 2 Study of Donor-Derived Multi-Tumor-Associated Antigen Specific T Cells (MT-401) Administered to Patients with Acute Myeloid Leukemia (AML) following Hematopoietic Stem Cell Transplantation

Summary

This study is a Phase 2 multicenter study with a Safety Lead-in evaluating safety and efficacy of MT-401 administration to patients with AML, who have received their first allogeneic HSCT. The dose administered is 50 x 10^6 cells (flat dosing).

Objective

Primary: Safety Lead-in: To assess safety and tolerability of MT-401 Phase 2: Adjuvant (Group 1): To compare relapse-free survival (RFS) for MT-401 (Arm A) vs standard of care (SOC; Arm B) Active Disease (Group 2): To estimate complete remission (CR) and duration of CR (DOCR) Secondary (Efficacy): Safety Lead in: To assess efficacy of MT-401 Phase 2 (Adjuvant Group 1): >To analyze overall survival (OS) for MT-401 (Arm A) and SOC (Arm B); >To compare graft-versus-host disease RFS (GRFS) for MT-401 (Arm A) vs SOC (Arm B). Phase 1 (Active Disease Group 2): >To evaluate overall response rate (ORR), duration of complete remission (DOR), progression-free survival (PFS) and OS for MT 401 alone; > To evaluate RFS, OS, and GRFS for patients who achieve CR following bridging therapy. Secondary (Safety): Phase 2 (Groups 1 and 2): >To evaluate the safety and tolerability of administering donor-derived MT 401 to patients with AML post-HSCT

Treatments

Therapies

Therapy (NOS)

Medications

MT-401 ()

Inclusion Criteria

1. First allogeneic HSCT, in > Adjuvant therapy for AML (Group 1) at 90 days (±10 days) post-HSCT defined as patients with CRMRD by central testing; and are MRD negative pre-transplant by local or central testing ; or Treatment for relapsed AML (first relapse post-HSCT) when disease occurs after transplant (Group 2) defined as:

First relapse (MRD+ or frank relapse) post-HSCT

Patients in Group 1 who are randomized to Arm 1B (SOC) and experience first relapse (MRD+ or frank relapse) post-HSCT or experience relapse prior to randomization.

Patients with frank relapse will enter into Subgroup C while patients with MRD+ disease will enter into Subgroup D

Safety Lead-in (Cohorts I and II) and Cohorts III-V defined as patients whose prior treatment course does not meet precise eligibility criteria but may still be approved upon review by the Sponsor as described for Group 2 only

2. Are >18 years of age

3. Karnofsky/Lansky score of >60

4. Life expectancy >12 weeks

5. Adequate blood, liver, and renal function as defined by protocol

6. Patients are allowed to be on experimental conditioning regimens prior to transplant if no planned maintenance therapy post-transplant.

7. In Group 2, patients may receive bridging therapy at the investigators' discretion in situations where MT-401 is not ready for administration or the treating physician believes the patient would benefit

Exclusion Criteria

1. Clinically significant or severely symptomatic intercurrent infection

2. Pregnant or lactating

3. For Group 1, anti-neoplastic therapy after HSCT and prior to or during dosing of MT-401

4. For Group 2, concomitant anti-neoplastic therapy during or after dosing of MT-401

5. Evidence of acute or chronic GVHD ≥Grade 2 (exception: acute or chronic Grade 2 GVHD of skin allowed if stable) within one week prior to receiving MT-401

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