Relapsed/Refractory Multiple Myeloma
Conditions
Keywords
Multiple myeloma, Immunotherapy, iNKT cells
Brief summary
This is a Phase 1, open-label study to explore the safety, tolerability, and preliminary clinical activity of agenT-797, an unmodified, allogeneic iNKT cell therapy, in participants with relapsed or refractory multiple myeloma, as well as to define the recommended Phase 2 dose.
Interventions
DRUGagenT-797
agenT-797 is an off-the-shelf cell therapy consisting of ≥ 95% allogeneic human unmodified iNKT cells isolated from 1 healthy donor mononuclear cell apheresis unit and expanded ex vivo.
Sponsors
MiNK Therapeutics
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Relapsed/Refractory Multiple Myeloma 1. Confirmed diagnosis and evidence of progressive disease or clinical relapse as defined by International Myeloma Working Group criteria and following prior therapy for multiple myeloma (MM) 2. Relapsed or refractory MM requiring current treatment 3. Previously failed ≥ 3 prior regimens (after at least 2 cycles of medication per regimen) and included at least 1 immunomodulatory drug, 1 proteasome inhibitor, and an anti-CD38 antibody agent 4. Participants must have measurable disease as defined by at least 1 of the following: * Serum M-protein ≥ 0.5 grams/deciliter (dL) by serum protein electrophoresis or for immunoglobulin A (IgA) myeloma, by quantitative IgA; or * Urinary M-protein excretion at least 200 milligrams (mg)/24 hours; or * Serum free light chain whereby the involved light chain measures ≥ 10 mg/dL and with an abnormal ratio 2. Estimated life expectancy ≥ 3 months 3. No other medical, surgical, or psychiatric condition (including active substance abuse) that would interfere with compliance to the protocol, as determined by the principal investigator Key
Exclusion criteria
1. Concurrent invasive malignancy 2. Participants who had an allogeneic stem cell transplantation and are still on immunosuppressive medications or corticosteroids above physiological dose within 4 weeks before agenT-797 3. Prior radiotherapy within 2 weeks of start of study treatment 4. Prior systemic cytotoxic chemotherapy, biological therapy, or major surgery within 3 weeks prior to dose of study drug
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number Of Participants With Treatment-related Adverse Events | Baseline through Day 28 post cell infusion | This will be determined by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0. |
| Number Of Dose-limiting Toxicities | Baseline through Day 14 post cell infusion | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration Of Response (DOR) | End of study visit (up to 12 months) |
| Duration Of Clinical Benefit | End of study visit (up to 12 months) |
| Persistence Of agenT-797 In Peripheral Blood | Baseline/Day 1 (pre-infusion, 5 minutes, 0.25, 0,5, 1, 2, and 4 hours post cell infusion), Days 2, 3, 5, 8, 15, 22, and 29, Weeks 6, 8, and 12, and Months 6, 9, and 12 |
| Measurement Of Serum Alloantibodies To Major Histocompatibility Complex Class I And II | Baseline/Day 1 (pre-infusion), Day 22, Week 6, and end of study visit (up to 12 months) |
| Time To Response (TTR) | End of study visit (up to 12 months) |
| Overall Response Rate (ORR) | End of study visit (up to 12 months) |
Countries
United States
Outcome results
None listed