CRISPR-edited CAR-T cell therapy for multiple myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 study evaluates the safety and effectiveness of CB-011, an allogeneic CAR-T cell therapy targeting the B cell maturation antigen (BCMA), in patients with relapsed or refractory multiple myeloma. The study aims to determine the optimal dose of CB-011 while assessing its potential to treat patients whose disease has returned or is unresponsive to previous therapies. Participants must have measurable disease and a history of multiple prior treatments, including specific drug classes. The trial will also monitor participants for any adverse effects associated with the therapy.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• CU Anschutz Medical Campus, Anshutz Cancer Pavillion
  Aurora, Colorado, United States Recruiting
• Sylvester Comprehensive Cancer Center, University of Miami Hospital and Clinics
  Miami, Florida, United States Recruiting
• University of Kentucky/ Markey Cancer Center
  Lexington, Kentucky, United States Recruiting
• Hackensack Meridian John Theurer Cancer Center
  Hackensack, New Jersey, United States Recruiting
• Icahn School of Medicine at Mount Sinai
  New York, New York, United States Recruiting

Study contacts

• Study coordinator: Caribou Biosciences
• Email: clinicaltrials@cariboubio.com
• Phone: 510-982-6030

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• CD7 CAR T-Cell Therapy for T-Cell Lymphomas

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.