agenT-797 in Participants With Relapsed/Refractory Multiple Myeloma

Relapsed/Refractory Multiple Myeloma Clinical Trial

Official title:

A Phase 1, Open-Label Study of the Safety, Tolerability, and Preliminary Clinical Activity of Allogeneic Invariant Natural Killer T (iNKT) Cells (agenT-797) in Subjects With Relapsed/Refractory Multiple Myeloma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04754100
• Other study ID #: 2019-1305
• Status: Completed
• Phase: Phase 1
• Start date: March 29, 2021
• Est. completion date: May 31, 2023

Study information

• Verified date: June 2023
• Source: MiNK Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: May 31, 2023
• Est. primary completion date: January 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Relapsed/Refractory Multiple Myeloma

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	University of Cincinnati Cancer Center	Cincinnati	Ohio
United States	Norton Cancer Institute - St. Matthews - Medical Oncology/Hematology Candida	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
MiNK Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number Of Dose-limiting Toxicities		Baseline through Day 14 post cell infusion
Secondary	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
Secondary	Overall Response Rate (ORR)		End of study visit (up to 12 months)
Secondary	Duration Of Response (DOR)		End of study visit (up to 12 months)
Secondary	Duration Of Clinical Benefit		End of study visit (up to 12 months)
Secondary	Time To Response (TTR)		End of study visit (up to 12 months)
Secondary	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)