AGENT-797 in Patients With Relapsed/Refractory Multiple Myeloma

• Status: Recruiting
• Trial end date: 2023-04-15
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase I, open-label, dose-escalation, single arm study to explore the safety, tolerability, and preliminary clinical activity of agenT-797, an unmodified, allogeneic iNKT cell therapy, in subjects with relapsed/refractory MM, as well as define the RP2D.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AgenTus Therapeutics, Inc.

Criteria

Inclusion Criteria:

• Written informed consent obtained prior to any screening procedures and in accordance with federal, local, and institutional guidelines.

• Age ≥ 18 years.

• Confirmed diagnosis, and evidence of progressive disease or clinical relapse as defined by International Myeloma Working Group (IMWG) criteria and following prior therapy for MM:

1. Relapsed or refractory MM requiring current treatment.

2. Previously failed ≥ 3 prior regimens.

• Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1.

• Estimated life expectancy ≥ 4 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.

• Female subjects of childbearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at Screening, and male subjects must use an effective barrier method of contraception if sexually active with a female of childbearing potential.

• Subjects need a functioning, central venous access in place for the administration of agenT-797.

Exclusion Criteria:

• Pregnant or nursing women.

• Prior history of invasive malignancy.

• Subjects who had an allogeneic stem cell transplantation and are still on immunosuppressive medications or corticosteroids above physiological dose.

• New York Heart Association Class III or IV heart failure, unstable angina, or a history of recent myocardial infarction.

• Adverse events from prior anticancer therapy that have not resolved to NCI CTCAE Grade ≤ 1.

• Receiving any investigational products within 4 weeks or 5 half-lives of cell infusion.