Phase 1b Study of Talquetamab Bridging Therapy Followed by Ciltacabtagene Autoleucel for Adults with Relapsed or Refractory Multiple Myeloma

What this Trial Is About

Researchers are evaluating the safety and feasibility of using talquetamab as a bridging therapy before administering ciltacabtagene autoleucel cilta-cel in patients with relapsed and refractory multiple myeloma RRMM. This phase 1b, single-arm, open-label study includes patients who have had at least one prior treatment and are eligible for both talquetamab and cilta-cel. The study aims to explore how well these therapies can be combined and managed in this patient population. Participants will first undergo a procedure called apheresis to collect cells. After this, they will receive one cycle of talquetamab given under the skin. If there are delays in manufacturing, an additional cycle of talquetamab may be provided. Once the cilta-cel product is ready, patients will receive lymphodepleting chemotherapy followed by an infusion of cilta-cel administered intravenously. The study treatment period includes these steps and is followed by monitoring. During the study, participants will be followed for up to six months after the cilta-cel infusion. Researchers will closely monitor for any serious side effects within 30 days after the cilta-cel treatment. Evaluations will include clinical assessments and laboratory tests to track safety and treatment effects. The total duration of participation depends on the treatment and follow-up schedule established by the study team.

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