RECRUITING

CRISPR-Edited Allogeneic Anti-BCMA CAR-T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma

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Conditions

Relapsed/Refractory Multiple MyelomaCaMMouflageAllogeneicMultiple MyelomaRelapse Refractory Multiple MyelomaCAR-T CellsBCMACell TherapyCellular Immuno-therapyCB11ACB-011CB-011ACAR-TAnti BCMAALLO CAR T

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

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)

Quick Facts

Study Start:2023-02-06
Study Completion:2027-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05722418

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Documented diagnosis of relapsed/refractory multiple myeloma (MM) with measurable disease (according to IMWG diagnostic criteria.)
  2. 2. Received at least 3 prior MM treatment lines of therapy which must include a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody as part of a prior line of therapy, either in monotherapy or in combination.
  3. 3. Eastern Cooperative Oncology Group performance status grade of 0 or 1.
  4. 4. Adequate hematologic, renal, hepatic, pulmonary, and cardiac function.
  1. 1. Prior treatment with CAR-T cell therapy directed at any target.
  2. 2. Autologous stem cell transplant within the last 6 weeks before lymphodepletion.
  3. 3. Allogeneic stem cell transplant within 6 months before lymphodepletion.
  4. 4. Known active or prior history of CNS involvement.
  5. 5. Stroke or seizure within 6 months of signing ICF.
  6. 6. Seropositive for or history of human immunodeficiency virus.
  7. 7. Vaccinated with live, attenuated vaccine within 4 weeks prior to lymphodepletion.
  8. 8. Hepatitis B infection.
  9. 9. Hepatitis C infection.
  10. 10. Known life-threatening allergies, hypersensitivity, or intolerance to CB-011 or its excipients.

Contacts and Locations

Study Contact

Caribou Biosciences
CONTACT
510-982-6030
clinicaltrials@cariboubio.com

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
CU Anschutz Medical Campus, Anshutz Cancer Pavillion
Aurora, Colorado, 80045
United States
Sylvester Comprehensive Cancer Center, University of Miami Hospital and Clinics
Miami, Florida, 33136
United States
University of Kentucky/ Markey Cancer Center
Lexington, Kentucky, 40536
United States
Massachusetts General
Boston, Massachusetts, 220071
United States
John Theurer Cancer Center at Hackensack UMC
Hackensack, New Jersey, 07601
United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Levine Cancer Institute
Charlotte, North Carolina, 28204
United States
Duke University Health System (DUHS)
Durham, North Carolina, 27705
United States
Oncology Hematology Care, Inc
Cincinnati, Ohio, 45236
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, 84112
United States
Virginia Commonwealth University
Richmond, Virginia, 23235
United States
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Caribou Biosciences, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-06
Study Completion Date2027-02

Study Record Updates

Study Start Date2023-02-06
Study Completion Date2027-02

Terms related to this study

Keywords Provided by Researchers

  • CaMMouflage
  • Allogeneic
  • Multiple Myeloma
  • Relapse Refractory Multiple Myeloma
  • CAR-T Cells
  • BCMA
  • Cell Therapy
  • Cellular Immuno-therapy
  • CB11A
  • CB-011
  • CB-011A
  • CAR-T
  • Anti BCMA
  • ALLO CAR T

Additional Relevant MeSH Terms

  • Relapsed/Refractory Multiple Myeloma