NCT05801939

Cevostamab Following CAR T Cell Therapy for RRMM

Phase 2 Study of Cevostamab Consolidation Following BCMA CAR T Cell Therapy for Relapsed/Refractory Multiple Myeloma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2, open-label, single-arm, single stage, single-institution study, with an initial safety run-in period. Potential participants with relapsed/refractory myeloma who are undergoing standard of care, commercially-available BCMA-directed CAR T cell therapy may be identified pre-CAR T cell infusion but are not consented and enrolled until at least 4-6 weeks after CAR T cell infusion, once recovered from acute toxicities. Note: the lymphodepleting chemotherapy and CAR T cell therapy is being administered as part of standard clinical practice and is not considered part of this protocol. Alternative lymphodepleting regimens other than fludarabine and cyclophosphamide (eg in the setting of fludarabine shortages) are acceptable. Cevostamab will be given as an IV infusion once every 3 weeks, starting roughly 10 weeks (day 70 +/- 4 days) post-CAR T cell infusion, with subjects planned to receive 8 cycles initially. Aiming to assess the impact of cevostamab consolidation post-BCMA CAR T cell therapy on rate of MRD-negative complete remission (CR) at 12 months.

Conditions

• Relapsed/Refractory Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Cevostamab	Cevostamab will be given as an IV infusion once every 3 weeks, starting roughly 10 weeks (day 70 +/- 4 days) post-CAR T cell infusion, with subjects planned to receive 8 cycles initially. Subjects receive a single step-up dose of 3.6 mg of cevostamab on cycle 1, day 1 (C1D1), followed by the recommended target dose (160 mg, 132mg, or 90 mg based on results of safety run-in data and safety review) on C1D8. Myeloma responses are assessed every cycle, and a repeat bone marrow aspirate and biopsy (BMbx) is performed at the start of cycle 8. If participants are not in an MRD-negative CR at this timepoint (or if the BM bx is inevaluable/indeterminate for CR or MRD testing), they continue with another 8 cycles (C9-16) of cevostamab. If they are in MRD-negative CR at start of C8, they stop therapy after receiving this cycle and are observed.

Timeline

• Start date: 2023-07-11
• Primary completion: 2027-05-01
• Completion: 2028-05-01
• First posted: 2023-04-06
• Last updated: 2025-12-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study