Actively Recruiting
A Phase 1b Clinical Trial of CRISPR Delivered Anti-BCMA Chimeric Antigen Receptor T Cells for Treatment of Relapsed or Refractory Multiple Myeloma
Led by Thomas Martin, MD · Updated on 2026-03-10
30
Participants Needed
1
Research Sites
782 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, side effects, and best dose of CRISPR-delivered anti-BCMA CAR-T cells in patients with relapsed or refractory multiple myeloma. This phase Ib trial focuses on patients whose cancer has returned or not responded to previous treatments. The study aims to find the maximum tolerated dose and assess the response rates compared to historical treatments, as well as to monitor neurologic events and quality of life. Participants undergo leukapheresis to collect T cells, followed by lymphodepleting chemotherapy with fludarabine and cyclophosphamide on days -5, -4, and -3. They then receive a single infusion of anti-BCMA CAR-T cells at doses varying by study phase, infused over 5 to 30 minutes on day 1 if no disease progression or unacceptable toxicity occurs. Imaging scans, blood, urine sample collection, and bone marrow biopsies are performed throughout the study. After treatment, participants are followed up at 30, 60, and 90 days, then at 6 and 12 months, and yearly for up to 15 years. Researchers monitor treatment-emergent adverse events, dose-limiting toxicity, overall response rates, neurologic events, and duration of response. Quality of life is assessed using questionnaires. The long-term follow-up helps evaluate the persistence of CAR-T cells and ongoing safety and efficacy.
CONDITIONS
Brief Title
CRISPR Delivered Anti-BCMA Car-T Therapy for Relapsed or Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Ability to voluntarily sign informed consent
- ECOG performance status of 0 or 1
- Diagnosed with relapsed or refractory multiple myeloma with at least 3 prior therapies including proteasome inhibitor, immunomodulatory therapy, and anti-CD38 antibody therapy
- May have received BCMA targeted therapy but at least 6 months since last BCMA treatment
- Evidence of disease progression within 12 months of last therapy or refractory to most recent treatment
- Measurable disease by serum or urine M-protein or serum free light chain levels
- Adequate bone marrow, liver, kidney, cardiac, and pulmonary function
- Women of childbearing potential must have negative pregnancy test and agree to contraception for 1 year after treatment
- Males with partners of childbearing potential must agree to contraception for 6 months after treatment
You will not qualify if you...
- Autologous transplant within 12 weeks before planned CAR-T infusion
- Recent investigational, monoclonal antibody, cytotoxic, proteasome inhibitor, immunomodulatory, or radiotherapy within specified time windows before apheresis
- Unresolved toxicity from prior anticancer therapy except certain conditions
- Active CNS multiple myeloma, plasma cell leukemia, primary AL amyloidosis, or POEMS syndrome
- Active other malignancies except some treated or indolent cases
- HIV infection
- Active hepatitis B or C infection confirmed by PCR
- Uncontrolled illnesses including infection, heart failure, arrhythmia, pulmonary disease, or psychiatric/social issues limiting compliance
- Pregnant or breastfeeding women
- Symptomatic CNS diseases or recent seizures or strokes within 6 months
- Autoimmune diseases requiring immunosuppressive medication within 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo leukapheresis to collect immune cells for CAR-T cell manufacturing.
1 visit (in-person)
Duration - 3 days
Participants receive lymphodepleting chemotherapy with fludarabine and cyclophosphamide intravenously over 3 days before CAR-T infusion.
3 visits (in-person) on days -5, -4, and -3
Duration - 1 day
Participants receive a single infusion of anti-BCMA CAR-T cells targeting multiple myeloma.
1 visit (in-person) on day 1
Duration - Up to 15 years
Participants are followed for safety, efficacy, and quality of life assessments including blood and urine samples, bone marrow biopsies, and imaging studies.
Visits at 30, 60, and 90 days; 6 and 12 months; then yearly follow-up visits
Trial Site Locations
Total: 1 location
1
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
Research Team
H
HDFCCC Cancer Immunotherapy Program (CIP)
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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