Back to resultsCRISPR-Edited Allogeneic Anti-BCMA CAR-T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma (CaMMouflage)
Primary Purpose
Relapsed/Refractory Multiple Myeloma
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CB-011
Sponsored by
About this trial
This is an interventional treatment trial for Relapsed/Refractory Multiple Myeloma focused on measuring 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
Eligibility Criteria
Inclusion Criteria: Documented diagnosis of relapsed/refractory multiple myeloma (MM) with measurable disease (according to IMWG diagnostic criteria.) 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. Eastern Cooperative Oncology Group performance status grade of 0 or 1. Adequate hematologic, renal, hepatic, pulmonary, and cardiac function. Exclusion Criteria: Prior treatment with CAR-T cell therapy directed at any target. Autologous stem cell transplant within the last 6 weeks before lymphodepletion. Allogeneic stem cell transplant within 6 months before lymphodepletion. Known active or prior history of CNS involvement. Stroke or seizure within 6 months of signing ICF. Seropositive for or history of human immunodeficiency virus. Vaccinated with live, attenuated vaccine within 4 weeks prior to lymphodepletion. Hepatitis B infection. Hepatitis C infection. Known life-threatening allergies, hypersensitivity, or intolerance to CB-011 or its excipients.
Sites / Locations
- Icahn School of Medicine at Mount SinaiRecruiting
- Memorial Sloan Kettering Cancer CenterRecruiting
- Oncology Hematology Care, IncRecruiting
- Cleveland ClinicRecruiting
- Sarah Cannon Research InstituteRecruiting
- The University of Texas MD Anderson Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CB-011
Arm Description
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
Outcomes
Primary Outcome Measures
(Part A) Number of patients with dose limiting toxicities (DLT)
Number of patients with DLTs during the 28 days following the first administration of CB-011.
(Part B) Overall Response Rate (ORR)
The ORR will be evaluated by International Myeloma Working Group (IMWG) criteria.
Secondary Outcome Measures
Full Information
NCT ID
NCT05722418
First Posted
December 19, 2022
Last Updated
September 10, 2023
Sponsor
Caribou Biosciences, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05722418
Brief Title
CRISPR-Edited Allogeneic Anti-BCMA CAR-T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma
Acronym
CaMMouflage
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)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 6, 2023 (Actual)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
February 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Caribou Biosciences, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed/Refractory Multiple Myeloma
Keywords
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CB-011
Arm Type
Experimental
Arm Description
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 Type
Biological
Intervention Name(s)
CB-011
Other Intervention Name(s)
Cyclophosphamide, Fludarabine
Intervention Description
CB-011 allogeneic CAR T cell therapy targeting BCMA Cyclophosphamide Chemotherapy for lymphodepletion Fludarabine Chemotherapy for lymphodepletion
Primary Outcome Measure Information:
Title
(Part A) Number of patients with dose limiting toxicities (DLT)
Description
Number of patients with DLTs during the 28 days following the first administration of CB-011.
Time Frame
28 days
Title
(Part B) Overall Response Rate (ORR)
Description
The ORR will be evaluated by International Myeloma Working Group (IMWG) criteria.
Time Frame
12 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Documented diagnosis of relapsed/refractory multiple myeloma (MM) with measurable disease (according to IMWG diagnostic criteria.)
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.
Eastern Cooperative Oncology Group performance status grade of 0 or 1.
Adequate hematologic, renal, hepatic, pulmonary, and cardiac function.
Exclusion Criteria:
Prior treatment with CAR-T cell therapy directed at any target.
Autologous stem cell transplant within the last 6 weeks before lymphodepletion.
Allogeneic stem cell transplant within 6 months before lymphodepletion.
Known active or prior history of CNS involvement.
Stroke or seizure within 6 months of signing ICF.
Seropositive for or history of human immunodeficiency virus.
Vaccinated with live, attenuated vaccine within 4 weeks prior to lymphodepletion.
Hepatitis B infection.
Hepatitis C infection.
Known life-threatening allergies, hypersensitivity, or intolerance to CB-011 or its excipients.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
DeShaun Noakes, MS
Phone
7605334023
Email
dnoakes@cariboubio.com
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adriana Rossi, MD
Phone
917-828-3905
Email
adriana.rossi@mssm.edu
First Name & Middle Initial & Last Name & Degree
Adriana Rossi, MD
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sham Mailankody, MBBS
Phone
646-608-2091
Email
cart@mskcc.org
First Name & Middle Initial & Last Name & Degree
Sham Mailankody, MBBS
Facility Name
Oncology Hematology Care, Inc
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Doug Hart
Email
douglas.hart@usoncology.com
First Name & Middle Initial & Last Name & Degree
James Essell, MD
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
216-444-7923
Email
Canceranswer@ccf.org
First Name & Middle Initial & Last Name & Degree
Faiz Anwer, MD
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jesus Berdeja, MD
Phone
844-482-4812
Email
asksarah@sarahcannon.com
First Name & Middle Initial & Last Name & Degree
Jesus Berdeja, MD
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shiny Jayan
Phone
832-438-7390
Email
sjayan@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Neeraj Saini, MD
12. IPD Sharing Statement
Learn more about this trial
CRISPR-Edited Allogeneic Anti-BCMA CAR-T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma
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