agenT-797 in Participants With Relapsed/Refractory Multiple Myeloma

NCT04754100 | Completed Phase 1 FDA Drug

• 1 other identifier: 2019-1305
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 3

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

Keywords

Multiple myeloma; Immunotherapy; iNKT cells

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (6)

• 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)

• 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)

Study Arms (1)

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 \[2 weeks\]).

Drug: agenT-797

Interventions

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.

Allogeneic iNKT Cells

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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
• 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

You may not qualify if:

• Concurrent invasive malignancy
• 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
• Prior radiotherapy within 2 weeks of start of study treatment
• Prior systemic cytotoxic chemotherapy, biological therapy, or major surgery within 3 weeks prior to dose of study drug

Sponsors & Collaborators

• MiNK Therapeutics: lead

Study Sites (3)

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

Louisville, Kentucky, 40207, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

University of Cincinnati Cancer Center

Cincinnati, Ohio, 45267, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Medical Director

  MiNK Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: February 15, 2021
• Study Start: March 29, 2021
• Primary Completion: January 13, 2023
• Study Completion: May 31, 2023
• Last Updated: June 6, 2023

Record last verified: 2023-06

Locations

US (3)