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

Phase 1

Recruiting

• Conditions: Relapsed/Refractory Multiple Myeloma
• Interventions: Biological: CB-011

• Registration Number: NCT05722418
• Lead Sponsor: Caribou Biosciences, Inc.

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-19
• Study First Submitted QC: 2023-02-02
• Study Start: 2023-02-06
• Study First Posted: 2023-02-10
• Status Verified: 2024-05
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-11
• Primary Completion: 2025-05
• Study Completion: 2027-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
CB-011	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

Primary Outcome Measures

Name	Time	Method
(Part B) Overall Response Rate (ORR)	12 Months	The ORR will be evaluated by International Myeloma Working Group (IMWG) criteria.
(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.

Trial Locations

Locations (16)

Hackensack Meridian John Theurer Cancer Center; 🇺🇸 Hackensack, New Jersey, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

CU Anschutz Medical Campus, Anshutz Cancer Pavillion; 🇺🇸 Aurora, Colorado, United States

Sylvester Comprehensive Cancer Center, University of Miami Hospital and Clinics; 🇺🇸 Miami, Florida, United States

University of Kentucky/ Markey Cancer Center; 🇺🇸 Lexington, Kentucky, 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

Levine Cancer Institute; 🇺🇸 Charlotte, North Carolina, United States

Duke University Health System (DUHS); 🇺🇸 Durham, North Carolina, United States

Oncology Hematology Care, Inc; 🇺🇸 Cincinnati, Ohio, United States

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