Actively Recruiting
CRISPR Delivered Anti-BCMA Car-T Therapy for Relapsed or Refractory Multiple Myeloma
Led by Thomas Martin, MD · Updated on 2026-03-10
30
Participants Needed
1
Research Sites
899 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase Ib trial tests the safety, side effects and best dose of clustered regularly interspaced short palindromic repeats (CRISPR) delivered anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR)-T cells (1XX BCMA CAR-T cells) in treating patients with multiple myeloma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Anti-BCMA CAR-T cell therapy is a type of treatment in which a person's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein, such as BCMA, on the patient's cancer cells is added to the T cells in the laboratory by a tool called clustered regularly interspaced short palindromic repeats (CRISPR)-Cas9. The special receptor is called a CAR. Large numbers of the CAR-T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Giving chemotherapy before CAR-T cells may decrease the number of lymphocytes (a type of white blood cells) in the blood and may help the 1XX BCMA CAR-T cells fight the cancer cells. Treatment with 1XX BCMA CAR-T cells may be safe, tolerable, and/or effective in treating patients with relapsed or refractory multiple myeloma (RRMM).
CONDITIONS
Official Title
CRISPR Delivered Anti-BCMA Car-T Therapy for Relapsed or Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign informed consent form.
- Age 18 years or older.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Diagnosis of multiple myeloma with relapsed or refractory disease after at least 3 prior lines of therapy including proteasome inhibitor, immunomodulatory therapy, and anti-CD38 antibody therapy.
- May have received BCMA targeted therapy but must be at least 6 months from last BCMA therapy.
- Documented progressive disease within 12 months of last therapy or refractory to most recent therapy.
- Measurable disease with serum M-protein ≥0.5 g/dL, or urine M-protein ≥200 mg/24 h, or serum free light chain level ≥100 mg/L.
- Adequate organ function including bone marrow, liver, kidney, cardiac and pulmonary function.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception for 1 year after treatment.
- Males with partners of childbearing potential must agree to use barrier contraception for 6 months after treatment.
You will not qualify if you...
- Autologous transplant within 12 weeks before planned CAR-T cell infusion.
- Recent prior antitumor therapy before apheresis including investigational agents, monoclonal antibodies, cytotoxic therapy, proteasome inhibitors, immunomodulatory therapy, or radiotherapy within specified time frames.
- Ongoing toxicity from previous cancer therapy except for certain conditions like alopecia or controlled neuropathy.
- Active central nervous system multiple myeloma, plasma cell leukemia, primary AL amyloidosis, or POEMS syndrome.
- Active other malignancies except certain treated or insignificant cancers.
- HIV infection.
- Active hepatitis B or C infection unless PCR negative.
- Uncontrolled illness including infections, heart failure, arrhythmias, lung problems, or psychiatric conditions limiting study compliance.
- Pregnant or breastfeeding women.
- Symptomatic central nervous system disorders or recent seizure or stroke within 6 months.
- History of autoimmune disease requiring immunosuppressive medication within 6 months.
AI-Screening
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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)
CONTACT
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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