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

Sponsor

Caribou Biosciences, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05722418

Collaborator

(none)

Enrollment

Locations

Arm

47.8

Anticipated Duration (Months)

12.5

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Relapsed/Refractory Multiple Myeloma	Biological: CB-011	Phase 1

Study Design

Study Type:

Interventional

Anticipated 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 :

Feb 6, 2023

Anticipated Primary Completion Date :

Feb 1, 2025

Anticipated Study Completion Date :

Feb 1, 2027

Arms and Interventions

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

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

Primary Outcome Measures

(Part A) Number of patients with dose limiting toxicities (DLT) [28 days]
Number of patients with DLTs during the 28 days following the first administration of CB-011.
(Part B) Overall Response Rate (ORR) [12 Months]
The ORR will be evaluated by International Myeloma Working Group (IMWG) criteria.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Icahn School of Medicaine at Mount Sinai	New York	New York	United States	10029
2	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
3	Sarah Cannon Research Institution	Nashville	Tennessee	United States	37293
4	Huntsman Cancer Institute (Univ of Utah)	Salt Lake City	Utah	United States	84112