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

Relapsed/Refractory Multiple Myeloma Clinical Trial

— 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05722418
• Other study ID #: CB11A
• Status: Recruiting
• Phase: Phase 1
• Start date: February 6, 2023
• Est. completion date: February 2027

Study information

• Verified date: March 2024
• Source: Caribou Biosciences, Inc.
• Contact: Caribou Biosciences
• Phone: 510-982-6030
• Email: clinicaltrials[@]cariboubio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 2027
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Relapsed/Refractory Multiple Myeloma

Intervention

Biological:
• CB-011
CB-011 allogeneic CAR T cell therapy targeting BCMA Cyclophosphamide Chemotherapy for lymphodepletion Fludarabine Chemotherapy for lymphodepletion

Locations

Country	Name	City	State
United States	CU Anschutz Medical Campus, Anshutz Cancer Pavillion	Aurora	Colorado
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Massachusetts General	Boston	Massachusetts
United States	Levine Cancer Institute	Charlotte	North Carolina
United States	Oncology Hematology Care, Inc	Cincinnati	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Duke University Health System (DUHS)	Durham	North Carolina
United States	John Theurer Cancer Center at Hackensack UMC	Hackensack	New Jersey
United States	The University of Texas MD Anderson Cancer Center	Houston	Texas
United States	University of Kentucky/ Markey Cancer Center	Lexington	Kentucky
United States	Sylvester Comprehensive Cancer Center, University of Miami Hospital and Clinics	Miami	Florida
United States	Froedtert and the Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Huntsman Cancer Institute, University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Caribou Biosciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	(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.	28 days
Primary	(Part B) Overall Response Rate (ORR)	The ORR will be evaluated by International Myeloma Working Group (IMWG) criteria.	12 Months