NCT05020444

TriPRIL CAR T Cells in Multiple Myeloma

A Phase I Clinical Trial With TriPRIL CAR T Cells for the Treatment of Patients With Relapsed or Refractory Multiple Myeloma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Marcela V. Maus, M.D.,Ph.D. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study involves the study of TriPRIL CAR T Cells for treating people with relapsed or refractory multiple myeloma and to understand the side effects when treated with TriPRIL CAR T Cells. This research study involves the study drugs:. * TriPRIL CAR T Cells * Fludarabine and Cyclophosphamide: Standardly used chemotherapy drugs as part of lymphodepleting process

Detailed description

This is a two-part, non-randomized, open label, single-site Phase 1 study of TriPRIL CAR T Cells as a treatment for relapsed or refractory multiple myeloma. This study consists of 2 parts: * Part A (Dose Escalation) : The investigators are looking to find the highest dose of the study intervention that can be administered safely without severe or unmanageable side effects, not everyone who participates in this research study will receive the same dose of the study intervention. The dose given will depend on the number of participants who have been enrolled prior and how well the dose was tolerated Once determined, this highest dose will then be used in the dose expansion part of the study. * Part B (Expansion Cohort):Participants will be treated at the respective dose as determined during Part A (Dose Escalation). TriPRIL CAR T Cells is an investigational treatment that uses a person's own immune cells, called T cells, to try to kill their cancerous cells. T cells fight infections and can also kill cancer cells in some cases. The U.S. Food and Drug Administration (FDA) has not approved TriPRIL CAR T Cells as a treatment for any disease.This is the first time that TriPRIL CAR T Cells will be given to humans. The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. Participants will receive one infusion of the study treatment and will be followed for up to 2 years. It is expected that about 18 people will take part in this research study.

Conditions

• Multiple Myeloma
• Multiple Myeloma in Relapse
• Refractory Multiple Myeloma

Interventions

Type	Name	Description
DRUG	TriPRIL CAR T Cells	Intravenous infusion
DRUG	Cyclophosphamide	Intravenous infusion
DRUG	Fludarabine	Intravenous infusion

Timeline

• Start date: 2021-10-05
• Primary completion: 2026-03-31
• Completion: 2028-03-31
• First posted: 2021-08-25
• Last updated: 2026-02-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study