Summary

Eligibility
for people ages 18-71 (full criteria)
Location
at UCSF
Dates
study started
study ends around

Description

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).

Official Title

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

Details

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/m2 and fludarabine 30mg/m2 for 3 consecutive days followed by the infusion of BCMA CAR T-cells at a target dose of 450 x106 cells. Maintenance lenalidomide, starting at 10mg 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

Keywords

Multiple Myeloma, CAR T-cells, Anti-Myeloma Agents, lenalidomide, Maintenance Therapy, Hematologic Disorders, Infusion, Lenalidomide and bb2121

Eligibility

Locations

  • University of California, San Francisco
    San Francisco California 94143 United States
  • City of Hope National Medical Center
    Duarte California 91010 United States
  • Stanford Hospital and Clinics
    Palo Alto California 94305 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Marcelo Pasquini, MD
Links
Blood and Marrow Transplant Clinical Trials Network Website
ID
NCT05032820
Phase
Phase 2 research study
Study Type
Interventional
Participants
About 40 people participating
Last Updated