CRISPR-Edited Allogeneic Anti-BCMA CAR-T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CB-011.
- Who it may be relevant to
- Registry conditions: Relapsed/Refractory Multiple Myeloma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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)
Overview
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).
Interventions
- Biological CB-011
CB-011 allogeneic CAR T cell therapy targeting BCMA Cyclophosphamide Chemotherapy for lymphodepletion Fludarabine Chemotherapy for lymphodepletion
Primary outcome measures
- (Part A) Number of patients with dose limiting toxicities (DLT) [Time frame: 28 days]
- (Part B) Overall Response Rate (ORR) [Time frame: 12 Months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 16 centers
- University of Alabama at Birmingham — Birmingham
- CU Anschutz Medical Campus, Anshutz Cancer Pavillion — Aurora
- Sylvester Comprehensive Cancer Center, University of Miami Hospital and Clinics — Miami
- University of Kentucky/ Markey Cancer Center — Lexington
- Hackensack Meridian John Theurer Cancer Center — Hackensack
- Icahn School of Medicine at Mount Sinai — New York
- Memorial Sloan Kettering Cancer Center — New York
- Levine Cancer Institute — Charlotte
- … and 8 more centers
Identifiers
NCT: NCT05722418 · CB11A