MM CAR-T to Upgrade Response BMTCTN1902

Status Active, not recruiting

Clinical Trial 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).

Clinical Trial 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/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 ;

Study Design

Related Conditions & MeSH terms

Multiple Myeloma

Clinical Trial Details

NCT number	NCT05032820
Study type	Interventional
Source	Medical College of Wisconsin
Contact
Status	Active, not recruiting
Phase	Phase 2
Start date	January 5, 2022
Completion date	April 2025

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05027594` - Ph I Study in Adult Patients With Relapsed or Refractory Multiple Myeloma	Phase 1
Completed	`NCT02412878` - Once-weekly Versus Twice-weekly Carfilzomib in Combination With Dexamethasone in Adults With Relapsed and Refractory Multiple Myeloma	Phase 3
Completed	`NCT01947140` - Pralatrexate + Romidepsin in Relapsed/Refractory Lymphoid Malignancies	Phase 1/Phase 2
Recruiting	`NCT05971056` - Providing Cancer Care Closer to Home for Patients With Multiple Myeloma	N/A
Recruiting	`NCT05243797` - Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation	Phase 3
Active, not recruiting	`NCT04555551` - MCARH109 Chimeric Antigen Receptor (CAR) Modified T Cells for the Treatment of Multiple Myeloma	Phase 1
Recruiting	`NCT05618041` - The Safety and Efficay Investigation of CAR-T Cell Therapy for Patients With Hematological Malignancies	N/A
Active, not recruiting	`NCT03844048` - An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial	Phase 3
Recruiting	`NCT03412877` - Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer	Phase 2
Completed	`NCT02916979` - Myeloid-Derived Suppressor Cells and Checkpoint Immune Regulators' Expression in Allogeneic SCT Using FluBuATG	Phase 1
Recruiting	`NCT03570983` - A Trial Comparing Single Agent Melphalan to Carmustine, Etoposide, Cytarabine, and Melphalan (BEAM) as a Preparative Regimen for Patients With Multiple Myeloma Undergoing High Dose Therapy Followed by Autologous Stem Cell Reinfusion	Phase 2
Terminated	`NCT03399448` - NY-ESO-1-redirected CRISPR (TCRendo and PD1) Edited T Cells (NYCE T Cells)	Phase 1
Completed	`NCT03665155` - First-in- Human Imaging of Multiple Myeloma Using 89Zr-DFO-daratumumab, a CD38-targeting Monoclonal Antibody	Phase 1/Phase 2
Completed	`NCT02812706` - Isatuximab Single Agent Study in Japanese Relapsed AND Refractory Multiple Myeloma Patients	Phase 1/Phase 2
Active, not recruiting	`NCT05024045` - Study of Oral LOXO-338 in Patients With Advanced Blood Cancers	Phase 1
Active, not recruiting	`NCT03989414` - A Study to Determine the Recommended Dose and Regimen and to Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM)	Phase 1/Phase 2
Active, not recruiting	`NCT03792763` - Denosumab for High Risk SMM and SLiM CRAB Positive, Early Myeloma Patients	Phase 2
Withdrawn	`NCT03608501` - A Study of Ixazomib, Thalidomide and Dexamethasone in Newly Diagnosed and Treatment-naive Multiple Myeloma (MM) Participants Non-eligible for Autologous Stem-cell Transplantation	Phase 2
Recruiting	`NCT04537442` - Clinical Study to Evaluate the Safety and Efficacy of IM21 CAR-T Cells in the Treatment of Elderly Patients With Relapsed or Refractory Multiple Myeloma	Phase 1
Completed	`NCT02546167` - CART-BCMA Cells for Multiple Myeloma	Phase 1