Clinical Trial

Disease: Relapsed or Refractory Multiple Myeloma, MM, (NCT05722418)

Disease info:

Multiple myeloma is a cancer that develops in the bone marrow, the spongy tissue found in the centre of most bones. Multiple myeloma is characterised by abnormalities in plasma cells, a type of white blood cell. In myeloma, these abnormal cells multiply uncontrollably, increasing from about one percent of cells in the bone marrow to the majority of bone marrow cells. The abnormal cells form tumours within the bone, causing bone pain and an increased risk of fractures.

Relapsed myeloma refers to when a patient had active treatment that their disease responded to, went off treatment and then the disease came back. 

Refractory myeloma is a disease that is progressing despite active treatment.

 

Frequency:
Multiple myeloma occurs in approximately 4 per 100,000 people per year; there are currently about 100,000 affected individuals in the United States.
Official title:
A Phase 1, Multicenter, Open-Label Study of CB-011, a CRISPR-Edited Allogeneic Anti-BCMA CAR-T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma (CaMMouflage Trial)
Who:

Contact

Name: Kellie McWilliams, MS

Phone Number: 2155142728

Email: clinicaltrials@cariboubio.com

 

Sponsor:

Caribou Biosciences

Partners:
Locations:

United States, Alabama
University of Alabama at Birmingham, Birmingham, Alabama, United States, 35294

United States, Florida
Sylvester Comprehensive Cancer Center, University of Miami Hospital and Clinics, Miami, Florida, United States, 33136

United States, Massachusetts 
Massachusetts General, Boston, Massachusetts, United States, 220071

United States, New Jersey 
John Theurer Cancer Center at Hackensack UMC, Hackensack, New Jersey, United States, 07601

United States, New York 
Icahn School of Medicine at Mount Sinai, New York, New York, United States, 10029

Memorial Sloan Kettering Cancer Center, New York, New York, United States, 10065

United States, Ohio 
Oncology Hematology Care, Inc, Cincinnati, Ohio, United States, 45236

Cleveland Clinic, United States, Cleveland, Ohio, United States, 44195

United States, Tennessee
Sarah Cannon Research Institute, Nashville, Tennessee, United States, 37203

United States, Texas 
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States, 77030

United States, Virginia
Virginia Commonwealth University, Richmond, Virginia, United States, 23235

Study start:
Feb. 6, 2023
Enrollment:
50 participants
Gene editing method:
Cas12a chRDNA (CRISPR hybrid RNA-DNA)
Type of edit:
Gene knock-out, gene knock-in
Gene:
B-cell maturation antigen (BCMA) T Cell Receptor Alpha Constant (TRAC) beta-2 microglobulin (B2M)
Delivery method:
Adeno-associated virus (AAV)
Trial link:
https://www.clinicaltrials.gov/ct2/show/NCT05722418
Safety updates:

(05-04-2023) CRISPR Clinical Trial Updates From Caribou Biosciences

(04-04-2023) Caribou Biosciences Announces FDA Granted Fast Track Designation to CB-011, an Allogeneic CAR-T Cell Therapy for Relapsed or Refractory Multiple Myeloma

(29-03-2023) Caribou Biosciences Announces Dosing of First Patient in the CaMMouflage Phase 1 Trial of CB-011, an Allogeneic Anti-BCMA CAR-T Cell Therapy for the Treatment of Relapsed or Refractory Multiple Myeloma

(21-11-2022) Caribou Biosciences Announces FDA Clearance of IND Application for CB-011, an Allogeneic Anti-BCMA CAR-T Cell Therapy for the Treatment of Relapsed or Refractory Multiple Myeloma

Other links:

LinkCRISPR Clinical Trial Updates From Caribou Biosciences (April 2023)

Indicator
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Active recruiting

Description

This is a Phase 1 study to evaluate the safety of CB-011 (the study treatment), an allogeneic chimeric antigen receptor (CAR-T) cell therapy that targets the B cell maturation antigen (BCMA), to determine the best dose of CB-011, and to assess the effectiveness of CB-011 in treating multiple myeloma that has come back (relapsed) or that is no longer responding to other treatment (refractory).

Last updated: Jan. 6, 2024
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