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

April 8, 2024 updated by: Caribou Biosciences, Inc.

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)

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • University of Alabama at Birmingham
        • Contact:
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • Sylvester Comprehensive Cancer Center, University of Miami Hospital and Clinics
        • Contact:
        • Principal Investigator:
          • Jay Spiegel, MD
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Recruiting
        • University of Kentucky/ Markey Cancer Center
        • Contact:
        • Principal Investigator:
          • Gregory Monohan, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 220071
        • Recruiting
        • Massachusetts General
        • Contact:
        • Principal Investigator:
          • Andrew Branagan, MD
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • John Theurer Cancer Center At Hackensack UMC
        • Contact:
        • Principal Investigator:
          • David Siegal, MD
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Sham Mailankody, MBBS
          • Phone Number: 646-608-2091
          • Email: cart@mskcc.org
        • Principal Investigator:
          • Sham Mailankody, MBBS
      • New York, New York, United States, 10029
        • Recruiting
        • Icahn School of Medicine at Mount Sinai
        • Contact:
        • Principal Investigator:
          • Adriana Rossi, MD
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
      • Durham, North Carolina, United States, 27705
        • Recruiting
        • Duke University Health System (DUHS)
        • Principal Investigator:
          • Cristina Gasparetto, MD
        • Contact:
    • Ohio
      • Cincinnati, Ohio, United States, 45236
        • Recruiting
        • Oncology Hematology Care, Inc
        • Contact:
        • Principal Investigator:
          • James Essell, MD
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Contact:
        • Principal Investigator:
          • Faiz Anwer, MD
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Active, not recruiting
        • Sarah Cannon Research Institute
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas MD Anderson Cancer Center
        • Principal Investigator:
          • Neeraj Saini, MD
        • Contact:
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • Huntsman Cancer Institute, University of Utah
        • Principal Investigator:
          • Douglas Sborov, MD
        • Contact:
    • Virginia
      • Richmond, Virginia, United States, 23235
        • Recruiting
        • Virginia Commonwealth University
        • Contact:
        • Principal Investigator:
          • William Clark, MD
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Froedtert and The Medical College of Wisconsin
        • Principal Investigator:
          • Binod Dhakal, MD
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
(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.
28 days
(Part B) Overall Response Rate (ORR)
Time Frame: 12 Months
The ORR will be evaluated by International Myeloma Working Group (IMWG) criteria.
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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 Major Dates

Study Start (Actual)

February 6, 2023

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

December 19, 2022

First Submitted That Met QC Criteria

February 2, 2023

First Posted (Actual)

February 10, 2023

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CB11A

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Relapsed/Refractory Multiple Myeloma

Clinical Trials on CB-011

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malaysia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe