OncoMatch/Clinical Trials/NCT07340853
CRISPR Delivered Anti-BCMA Car-T Therapy for Relapsed or Refractory Multiple Myeloma
Is NCT07340853 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Chimeric Antigen Receptor T cells (CAR-T) Targeting BCMA and Biospecimen Collection for multiple myeloma.
Treatment: Cyclophosphamide · Chimeric Antigen Receptor T cells (CAR-T) Targeting BCMA · Biospecimen Collection · Fludarabine — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Biomarker criteria
Allowed: BCMA prior BCMA targeted therapy
Participants may have received BCMA targeted therapy and must be at least 6 months from last BCMA therapy
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: proteasome inhibitor
has received at least 3 prior lines of therapy including proteasome inhibitor immunomodulatory therapy, and anti-Cluster of differentiation 38 (CD38) antibody therapy
Must have received: immunomodulatory therapy
has received at least 3 prior lines of therapy including proteasome inhibitor immunomodulatory therapy, and anti-Cluster of differentiation 38 (CD38) antibody therapy
Must have received: anti-CD38 antibody therapy
has received at least 3 prior lines of therapy including proteasome inhibitor immunomodulatory therapy, and anti-Cluster of differentiation 38 (CD38) antibody therapy
Cannot have received: autologous transplant
Exception: within 12 weeks of planned CAR-T cell infusion
Autologous transplant within 12 weeks of planned CAR-T cell infusion
Cannot have received: investigational therapy
Exception: within 14 days, or at least 5 half-lives prior to apheresis
Investigational therapy within 14 days, or at least 5 half-lives
Cannot have received: monoclonal antibody therapy
Exception: within 21 days prior to apheresis
Monoclonal antibody therapy within 21 days
Cannot have received: cytotoxic chemotherapy
Exception: within 14 days prior to apheresis
Cytotoxic therapy within 14 days
Cannot have received: proteasome inhibitor
Exception: within 14 days prior to apheresis
Proteasome inhibitor therapy within 14 days
Cannot have received: immunomodulatory therapy
Exception: within 14 days prior to apheresis
Immunomodulatory therapy within 14 days
Cannot have received: radiation therapy
Exception: within 14 days prior to apheresis (exception: if radiotherapy covers <5% of marrow reserve - no rest window needed)
Radiotherapy within 14 days - with the exception that if radiotherapy (XRT) covers <5% of marrow reserve - no rest window needed
Lab requirements
Blood counts
Hgb >8 gm/dl (transfusions allowed); Platelets >50,000/uL (no platelet transfusion within 7 days of apheresis, transfusion permitted prior to lymphodepleting chemotherapy); ANC >1000/uL in absence of growth factor support (filgrastim within 7 days or pegfilgrastim within 14 days of apheresis, growth factor permitted prior to lymphodepleting chemotherapy); For duffy null, ANC >750/uL allowed; ALC >300/uL
Kidney function
Serum creatinine clearance (CrCl) ≥ 30 mL/min using Cockcroft-Gault formula or as measured with a 24 hour urine collection
Liver function
ALT/AST < 3 x institutional ULN; Total bilirubin < 1.5 mg/dl x institutional ULN, except with Gilbert's syndrome
Cardiac function
LVEF > 40% as assessed by echocardiogram or MUGA; adequate pulmonary function (room air pulse oximetry ≥ 92%)
Adequate organ function, defined as: Adequate bone marrow function for apheresis and lymphodepleting chemotherapy. Hgb >8 gm/dl (transfusions allowed). Platelets >50,000/uL (in the absence of platelet transfusion within 7 days of apheresis, but transfusion permitted prior to lymphodepleting chemotherapy). ANC > 1000/uL in the absence of growth factor support (filgrastim within 7 days or pegfilgrastim within 14 days of apheresis, but growth factor permitted prior to lymphodepleting chemotherapy). For those patients who have evidence of duffy null, ANC >750/uL is allowed. Absolute lymphocyte count (ALC) >300/uL. ALT/AST < 3 x institutional upper limit of normal (ULN) and Total bilirubin < 1.5 mg/dl x institutional ULN, except with Gilbert's syndrome. Serum creatinine clearance (CrCl) ≥ 30 mL/min using Cockcroft-Gault formula or as measured with a 24 hour urine collection. Adequate cardiac function, defined as left ventricular ejection fraction (LVEF) > 40% as assessed by echocardiogram or multiple uptake gated acquisition (MUGA) and adequate pulmonary function (measured by room air pulse oximetry ≥ 92%).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of California, San Francisco · San Francisco, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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