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

ID#: NCT05722418

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 1

Recruitment Status: Recruiting

Start Date: February 06, 2023

End Date: December 01, 2027

Contact Information:
Caribou Biosciences
510-982-6030
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).
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.
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