NCT05431608

A Study of MCARH109 and MCARH125 in People With Multiple Myeloma

Phase I Trial of Concurrent Administration of GPRC5D-Targeted CAR T Cell MCARH109 and BCMA-Targeted CAR T Cell MCARH125 in Patients With Relapsed or Refractory Multiple Myeloma

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A sample of participants' T cells will be sent to a laboratory, where the cells will be made into the study therapy, MCARH109 and MCARH125. Participants will receive either MCARH125 alone or MCARH125 with MCARH109.

Conditions

• Multiple Myeloma
• Refractory Multiple Myeloma
• Relapse Multiple Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	MCARH125	MCARH109 and MCARH125 will be administered 2-7 days following the completion of conditioning chemotherapy. Each dose cohort will consist of 3-6 patients. MCARH109 and MCARH125 will be administered sequentially with 5-30 minutes between the two products.
BIOLOGICAL	MCARH109	MCARH109 and MCARH125 will be administered 2-7 days following the completion of conditioning chemotherapy. Each dose cohort will consist of 3-6 patients. MCARH109 and MCARH125 will be administered sequentially with 5-30 minutes between the two products.

Timeline

• Start date: 2022-06-20
• Primary completion: 2026-06-20
• Completion: 2026-06-20
• First posted: 2022-06-24
• Last updated: 2025-07-09

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study