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

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ClinicalTrials.gov Identifier: NCT05722418
Recruitment Status : Recruiting
First Posted : February 10, 2023
Last Update Posted : May 6, 2024
Sponsor:
Information provided by (Responsible Party):
Caribou Biosciences, Inc.

Tracking Information
First Submitted Date  ICMJE December 19, 2022
First Posted Date  ICMJE February 10, 2023
Last Update Posted Date May 6, 2024
Actual Study Start Date  ICMJE February 6, 2023
Estimated Primary Completion Date February 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 2, 2023)
  • (Part A) Number of patients with dose limiting toxicities (DLT) [ Time Frame: 28 days ]
    Number of patients with DLTs during the 28 days following the first administration of CB-011.
  • (Part B) Overall Response Rate (ORR) [ Time Frame: 12 Months ]
    The ORR will be evaluated by International Myeloma Working Group (IMWG) criteria.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CRISPR-Edited Allogeneic Anti-BCMA CAR-T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma
Official Title  ICMJE 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)
Brief Summary 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Relapsed/Refractory Multiple Myeloma
Intervention  ICMJE Biological: CB-011
CB-011 allogeneic CAR T cell therapy targeting BCMA Cyclophosphamide Chemotherapy for lymphodepletion Fludarabine Chemotherapy for lymphodepletion
Other Names:
  • Cyclophosphamide
  • Fludarabine
Study Arms  ICMJE Experimental: CB-011
  • Part A Escalation with CB-011 in ascending doses using a traditional 3+3 design.
  • Part B Expansion. Up to 30 participants will be enrolled to receive CB-011 at the RDE/MTD and/or RP2D determined in Plan A
Intervention: Biological: CB-011
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 2, 2023)		 50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2027
Estimated Primary Completion Date February 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Documented diagnosis of relapsed/refractory multiple myeloma (MM) with measurable disease (according to IMWG diagnostic criteria.)
  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. Eastern Cooperative Oncology Group performance status grade of 0 or 1.
  4. Adequate hematologic, renal, hepatic, pulmonary, and cardiac function.

Exclusion Criteria:

  1. Prior treatment with CAR-T cell therapy directed at any target.
  2. Autologous stem cell transplant within the last 6 weeks before lymphodepletion.
  3. Allogeneic stem cell transplant within 6 months before lymphodepletion.
  4. Known active or prior history of CNS involvement.
  5. Stroke or seizure within 6 months of signing ICF.
  6. Seropositive for or history of human immunodeficiency virus.
  7. Vaccinated with live, attenuated vaccine within 4 weeks prior to lymphodepletion.
  8. Hepatitis B infection.
  9. Hepatitis C infection.
  10. Known life-threatening allergies, hypersensitivity, or intolerance to CB-011 or its excipients.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Caribou Biosciences 510-982-6030 ext 3 clinicaltrials@cariboubio.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05722418
Other Study ID Numbers  ICMJE CB11A
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Caribou Biosciences, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Caribou Biosciences, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Caribou Biosciences, Inc.
Verification Date March 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP