Study to Evaluate the Safety of UF-KURE-BCMA CAR T-Cells in Advanced Myeloma

Starting soon · Phase 1

Conditions studied: Multiple Myeloma in Relapse, Multiple Myeloma, Refractory

In brief

The goal of this study is to evaluate the safety of a new type of CAR T-cell, UF-KURE-BCMA, for the treatment of patients with advanced multiple myeloma that has not responded to other therapies. The main question is whether the use of these new CAR T-cells is safe for patients with this condition. Secondarily, the study will also look at the response of myeloma to this therapy.

Key facts

Study ID: NCT07611149
Run by: Kure Cells, INC
People needed: 12
Starts: 2026-09-01
Expected to finish: 2028-12-30
Last updated by the study team: 2026-05-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subjects must meet ALL of the following criteria to be eligible for study enrollment:
Age: ≥18 years at time of signing informed consent
Diagnosis: Documented multiple myeloma meeting one of the following:
Relapsed disease: Progression after achieving at least minimal response (MR) to prior therapy
Refractory disease: Non-responsive or progressive disease while on therapy or within 60 days of last treatment (in subjects who achieved ≥MR on prior therapy)
Prior Therapy:
Received ≥3 prior lines of anti-myeloma therapy
Prior therapy must include:
At least one proteasome inhibitor At least one immunomodulatory drug (e.g., lenalidomide, pomalidomide, thalidomide) At least one anti-CD38 monoclonal antibody (e.g., daratumumab, isatuximab) o Prior anti-BCMA CAR-T therapy is permitted if subject achieved PFS ≥6 months post-infusion
Measurable Disease: At least one of the following at screening (for response assessment eligibility):
Serum M-protein ≥0.5 g/dL by protein electrophoresis (SPEP)
Urine M-protein ≥200 mg/24 hours by protein electrophoresis (UPEP)
Serum free light chain (FLC) difference ≥10 mg/dL with abnormal FLC ratio Note: Subjects with non-measurable disease may enroll for safety assessment
Performance Status: ECOG Performance Status 0-2 (see Appendix A)
Organ Function: Adequate organ function as defined by:
Hepatic:
o Total bilirubin ≤2× institutional upper limit of normal (ULN), except subjects with Gilbert's syndrome
AST and ALT ≤2.5× institutional ULN
Renal:
o Calculated creatinine clearance ≥30 mL/min (Cockcroft-Gault formula)
Cardiac:
o Left ventricular ejection fraction (LVEF) ≥45% by echocardiogram or MUGA
Pulmonary:
o ≤Grade 1 dyspnea
o Oxygen saturation ≥92% on room air

You may not qualify if…

Subjects meeting ANY of the following criteria will be excluded:
Disease-Specific Exclusions:
Active CNS involvement by multiple myeloma
Plasma cell leukemia
History of allogeneic hematopoietic stem cell transplantation
Malignancy Exclusions:
o Second active malignancy, except: Non-melanoma skin cancer Carcinoma in situ (cervix, bladder, breast) Stage 1 uterine cancer Localized prostate cancer
Cardiovascular Exclusions:
New York Heart Association (NYHA) Class IV congestive heart failure
Unstable angina pectoris
Clinically significant cardiac arrhythmias
Myocardial infarction, stroke, or TIA within 6 months of enrollment
Infectious Disease Exclusions:
Known HIV infection or AIDS-related illness
Active hepatitis B or C infection:
Positive HBsAg, or Positive anti-HBc or anti-HCV with detectable viral nucleic acid by PCR
Active infection requiring systemic therapy 5. Neurological Exclusions:
History of clinically relevant CNS pathology including:
Epilepsy or seizure disorders Paresis, aphasia Uncontrolled cerebrovascular disease Severe brain injury Dementia Parkinson's disease 6. Autoimmune Disease:
Active autoimmune disease requiring systemic immunosuppression >15 mg/day prednisone equivalent within past 6 months
Examples: rheumatoid arthritis, lupus

Full record on ClinicalTrials.gov

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