Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Allogeneic iNKT Cells | Experimental | 3+3 Dose escalation of agenT-797 will be administered by intravenous infusion every 2 weeks (each cycle is 14 days [2 weeks]). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| agenT-797 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number Of Participants With Treatment-related Adverse Events | This will be determined by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0. | Baseline through Day 28 post cell infusion |
| Number Of Dose-limiting Toxicities | Baseline through Day 14 post cell infusion |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Overall Response Rate (ORR) | End of study visit (up to 12 months) |
Not provided
Key Inclusion Criteria:
Relapsed/Refractory Multiple Myeloma
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)
Relapsed or refractory MM requiring current treatment
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
Participants must have measurable disease as defined by at least 1 of the following:
Estimated life expectancy ≥ 3 months
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | MiNK Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Norton Cancer Institute - St. Matthews - Medical Oncology/Hematology Candida | Louisville | Kentucky | 40207 | United States | ||
Not provided
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Duration Of Response (DOR) | End of study visit (up to 12 months) |
| Duration Of Clinical Benefit | End of study visit (up to 12 months) |
| Time To Response (TTR) | End of study visit (up to 12 months) |
| 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) |
| Dana-Farber Cancer Institute |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| University of Cincinnati Cancer Center | Cincinnati | Ohio | 45267 | United States |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |