NCT07093554

Cilta-Talq Fusion Study: A Phase 1b Study of Talquetamab Bridging Therapy Followed by Ciltacabtagene Autoleucel in Patients With Relapsed/Refractory Multiple Myeloma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (estimated)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, open-label, phase 1b study evaluating the safety and feasibility of using talquetamab as bridging therapy prior to cilta-cel in patients with relapsed and refractory multiple myeloma (RRMM).

Detailed description

This study will enroll patients with RRMM who have received at least one prior line of therapy and are eligible for both commercial talquetamab and cilta-cel. Patients will enroll prior to apheresis. Following apheresis, patients will receive one cycle of talquetamab therapy. An additional cycle of talquetamab will be allowed if manufacturing delays result in an expected lymphodepletion date \> 4 weeks from the last full dose of talquetamab in Cycle 1. Following successful manufacturing, patients will receive lymphodepleting chemotherapy and cilta-cel infusion.

Conditions

• Relapse Multiple Myeloma
• Refractory Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Talquetamab	Talquetamab will be administered subcutaneously.
DRUG	Ciltacabtagene Autoleucel	Ciltacabtagene Autoleucel will be administered intravenously.

Timeline

• Start date: 2025-12-02
• Primary completion: 2027-07-01
• Completion: 2028-01-01
• First posted: 2025-07-30
• Last updated: 2026-01-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study