NCT05032820

Upfront Chimeric Antigen Receptor T-Cell to Upgrade Response in Multiple Myeloma

Phase II Multicenter Trial of Anti-BCMA CAR T-Cell Therapy for MM Patients With Sub-Optimal Response After Auto HCT and Maintenance Len. BMTCTN1902

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed as a Phase II, multicenter, single arm trial to assess anti-B Cell Maturation Antigen (BCMA) chimeric antigen receptor (CAR) T-cells (bb2121) to improve post autologous hematopoietic cell transplant (HCT) responses among patients with multiple myeloma (MM).

Detailed description

After meeting the eligibility criteria and enrolling on the trial, patients will undergo leukapheresis for collection of autologous lymphocytes, which will be sent to BMS/Celgene manufacturing facilities. Once cells have been manufactured, patients will then proceed to lymphodepleting chemotherapy with cyclophosphamide 300mg/m\^2 and fludarabine 30mg/m\^2 for 3 consecutive days followed by the infusion of BCMA CAR T-cells at a target dose of 450 x10\^6 cells. Maintenance lenalidomide, starting at 5mg a day for 21 days of a 28-day cycle will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the patient reaches 12 months post CAR T-cell infusion and continue free of progression

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Lenalidomide	Maintenance lenalidomide, starting at 5 mg a day for 21 days of a 28-day cycle, will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the participant reaches 12 months post CAR T-cell infusion and continues free of progression
BIOLOGICAL	bb2121	Participants receive infusion of BCMA CAR T-cells at a target dose of 450 x 10\^6 cells.
DRUG	Cyclophosphamide	300 mg/m\^2/day for 3 consecutive days prior to the CAR T infusion
DRUG	Fludarabine	30 mg/m\^2/day or 3 consecutive days prior to the CAR T infusion
PROCEDURE	leukapheresis	Placement of central line catheter and leukapheresis

Timeline

• Start date: 2022-01-05
• Primary completion: 2024-08-22
• Completion: 2025-02-20
• First posted: 2021-09-02
• Last updated: 2026-03-05
• Results posted: 2026-01-12

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated drug study