agenT-797 in Participants With Relapsed/Refractory Multiple Myeloma

NCT ID: NCT04754100

Last Updated: 2023-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-29
• Study Completion Date: 2023-05-31

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.

Conditions

Relapsed/Refractory Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Allogeneic iNKT Cells

3+3 Dose escalation of agenT-797 will be administered by intravenous infusion every 2 weeks (each cycle is 14 days \[2 weeks\]).

Group Type: EXPERIMENTAL

agenT-797

Intervention Type: 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.

Interventions

agenT-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.

Intervention Type: DRUG

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MiNK Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

MiNK Therapeutics

Locations

Norton Cancer Institute - St. Matthews - Medical Oncology/Hematology Candida

Louisville, Kentucky, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

University of Cincinnati Cancer Center

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

2019-1305

Identifier Type: -

Identifier Source: org_study_id