The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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).

Condition or disease Intervention/treatment Phase
Relapsed/Refractory Multiple Myeloma Biological: CB-011 Phase 1

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : February 6, 2023
Estimated Primary Completion Date : February 2025
Estimated Study Completion Date : February 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Fludarabine

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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
 Biological: CB-011
CB-011 allogeneic CAR T cell therapy targeting BCMA Cyclophosphamide Chemotherapy for lymphodepletion Fludarabine Chemotherapy for lymphodepletion
Other Names:
  • Cyclophosphamide
  • Fludarabine


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. (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.

  2. (Part B) Overall Response Rate (ORR) [ Time Frame: 12 Months ]
    The ORR will be evaluated by International Myeloma Working Group (IMWG) criteria.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05722418


Contacts
Layout table for location contacts
Contact: Caribou Biosciences 510-982-6030 ext 3 clinicaltrials@cariboubio.com

Locations
Show Show 18 study locations
Sponsors and Collaborators
Caribou Biosciences, Inc.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Caribou Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT05722418    
Other Study ID Numbers: CB11A
First Posted: February 10, 2023    Key Record Dates
Last Update Posted: May 6, 2024
Last Verified: March 2024

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Caribou Biosciences, Inc.:
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:
Layout table for MeSH terms
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
 Immune System Diseases
Cyclophosphamide
Fludarabine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists