NCT07221032

FT836 CAR T-cell Therapy in Combination With Daratumumab in Patients With Relapsed and/or Refractory Multiple Myeloma

Phase I Study of FT836 CAR T-cell Therapy in Combination With Daratumumab in Patients With Relapsed and/or Refractory Multiple Myeloma

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I, interventional, single-arm, open-label, dose-finding treatment study designed to evaluate the safety and preliminary efficacy of FT836 in combination with daratumumab in adult patients with relapsed and/or refractory myeloma who have failed prior therapies.

Conditions

• Relapse Multiple Myeloma
• Refractory Multiple Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	FT836 CAR T cells (1 x 10^8 cells per dose)	FT836 CAR T cells will be administered by IV injection.
BIOLOGICAL	FT836 CAR T cells (3 x 108 cells per dose)	FT836 CAR T cells will be administered by IV injection.
BIOLOGICAL	FT836 CAR T cells (up to 9 x 108 cells per dose)	FT836 CAR T cells will be administered by IV injection.
DRUG	Daratumumab 16 mg/kg	Daratumumab will be administered intravenously.

Timeline

• Start date: 2026-07-01
• Primary completion: 2028-03-01
• Completion: 2030-03-01
• First posted: 2025-10-27
• Last updated: 2026-04-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study