NCT07340853 CRISPR Delivered Anti-BCMA Car-T Therapy for Relapsed or Refractory Multiple Myeloma
| NCT ID | NCT07340853 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Thomas Martin, MD |
| Condition | Multiple Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-02-28 |
| Primary Completion | 2028-05-25 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2026-02-28 with a primary completion date of 2028-05-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
Inclusion Criteria: 1. Voluntarily sign informed consent form. 2. Age ≥18 years. 3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 4. Diagnosis of multiple myeloma (per IMWG criteria) with relapsed or refractory disease and has received at least 3 prior lines of therapy including proteasome inhibitor immunomodulatory therapy, and anti-Cluster of differentiation 38 (CD38) antibody therapy. 5. Participants may have received BCMA targeted therapy and must be at least 6 months from last BCMA therapy. 6. Participants must have documented evidence of progressive disease within 12 months of the last line of therapy or be refractory/nonresponsive to their most recent line. 7. Participants must have measurable disease, defined as at least one of the criteria below: * Serum M-protein greater or equal to 0.5 grams per deciliter (g/dL). * Urine M-protein greater or equal to 200 milligrams, over a 24-hour period (mg/24 h). * Serum free light chain (FLC) assay: involved FLC level of ≥ 100 milligrams per liter (mg/L). 8. Adequate organ function, defined as: * Adequate bone marrow function for apheresis and lymphodepleting chemotherapy. * Hgb \>8 gm/dl (transfusions allowed). * Platelets \>50,000/microliter (uL) (in the absence of platelet transfusion within 7 days of apheresis, but transfusion permitted prior to lymphodepleting chemotherapy). * Absolute neutrophil count (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. * Alanine aminotransferase/aspartate aminotransferase (ALT/AST) \< 3 x institutional upper limit of normal (ULN) and Total bilirubin \< 1.5 milligrams per deciliter (mg/dl) x institutional ULN, except with Gilbert's syndrome. * Serum creatinine clearance (CrCl) ≥ 30 milliliter per minute (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%). 9. Women of childbearing potential must have a negative serum or urine pregnancy test AND agree to use highly effective methods of contraception for 1 year after the last dose of anti-BCMA CAR-T cells. 10. Males who have partners of childbearing potential must agree to use an effective barrier contraceptive method for 6 months after CAR-T therapy. Exclusion Criteria: 1. Autologous transplant within 12 weeks of planned CAR-T cell infusion. 2. Prior antitumor therapy as follows, prior to apheresis: * Investigational therapy within 14 days, or at least 5 half-lives. * Monoclonal antibody therapy within 21 days. * Cytotoxic therapy within 14 days. * Proteasome inhibitor therapy within 14 days. * Immunomodulatory therapy within 14 days. * Radiotherapy within 14 days - with the exception that if radiotherapy (XRT) covers \<5% of marrow reserve - no rest window needed. 3. Toxicity from previous anticancer therapy must resolve to baseline levels or to Grade 1 or less except for alopecia, peripheral neuropathy and baseline hematologic toxicity that otherwise meets inclusion. 4. Active CNS multiple myeloma, plasma cell leukemia, primary AL amyloidosis or POEMS syndrome. 5. Active other malignancy, other than non-melanoma skin cancer, carcinoma in situ (e.g., cervix, bladder, or breast). Any fully treated malignancies or indolent, clinically insignificant malignancies can be discussed among the study team to determine eligibility. 6. HIV seropositivity. 7. Serologic status reflects active hepatitis B or C infection. Participants that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment. (PCR positive participants will be excluded). 8. Participants with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, pulmonary abnormalities, or psychiatric illness/social situations that would limit compliance with study requirements. 9. Pregnant or breastfeeding women are excluded from this study because CAR-T cell therapy may be associated with the potential for teratogenic or abortifacient effects. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with CAR-T cells, breastfeeding should be discontinued. These potential risks may also apply to other agents used in this study. NOTE: Women of childbearing potential must have a negative serum or urine pregnancy test. 10. Participants with currently symptomatic central nervous system (CNS) pathology such as epilepsy, seizure disorders, paresis, aphasia, uncontrolled cerebrovascular disease, severe brain injuries, dementia, and Parkinson's disease OR seizure or stroke within 6 months. 11. History of autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus) with requirement of immunosuppressive medication within 6 months.
Contact & Investigator
Thomas G Martin, MD
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT07340853 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Multiple Myeloma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07340853 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07340853 currently recruiting?
Yes, NCT07340853 is actively recruiting participants. Contact the research team at HDFCCC.CIP@ucsf.edu for enrollment information.
Where is the NCT07340853 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT07340853 clinical trial?
NCT07340853 is sponsored by Thomas Martin, MD. The principal investigator is Thomas G Martin, MD at University of California, San Francisco. The trial plans to enroll 30 participants.