NCT07611149尚未招募1 期
A Phase 1, Single-Arm, Open-Label Study to Evaluate the Safety of UF-KURE-BCMA Cells in Patients With Relapsed or Refractory Multiple Myeloma
Kure Cells, INC0 个研究点目标入组 12 人开始时间: 2026年9月1日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12
研究概览
简要总结
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.
详细描述
This is a Phase I, single-arm, open-label, dose-escalation study using a 3+3 design that evaluates the safety of UF (ultrafast)- KURE-BCMA for patients with relapsed/refractory multiple myeloma. Eligible patients are adults (≥18 years) with relapsed or refractory multiple myeloma after ≥3 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody. The study will accrue a total of 12 patients.
The primary objectives of this study are:
- To determine the recommended Phase 2 dose (RP2D) of UF-KURE-BCMA
- To establish the safety profile and identify dose-limiting toxicities (DLTs)
The secondary objectives:
- Manufacturing feasibility
- Overall response rate (ORR) per IMWG criteria
- Duration of response (DOR)
- Progression-free survival (PFS)
- Overall survival (OS)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •o Total bilirubin ≤2× institutional upper limit of normal (ULN), except subjects with Gilbert's syndrome
- •AST and ALT ≤2.5× institutional ULN
- •o Calculated creatinine clearance ≥30 mL/min (Cockcroft-Gault formula)
- •o Left ventricular ejection fraction (LVEF) ≥45% by echocardiogram or MUGA
- •o ≤Grade 1 dyspnea
- •o Oxygen saturation ≥92% on room air
- •o If PFTs performed: FEV₁ ≥50% predicted and DLCO ≥40% predicted (corrected for hemoglobin)
- •Prior Therapy Washout:
- •o ≥2 weeks since last radiation or systemic anti-myeloma therapy (standard agents)
- •o ≥4 weeks since last investigational therapy
- •o ≥6 weeks since autologous stem cell transplant
- •Informed Consent: Ability to understand and willingness to provide written informed consent
- •Contraception Requirements (for subjects of reproductive potential):
- •Female subjects:
- •o Women of childbearing potential must: Have negative serum pregnancy test at screening Agree to use highly effective contraception (failure rate <1% per year) from enrollment through 6 months post-CAR-T infusion
- •Acceptable methods: bilateral tubal ligation, male partner sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing IUD, copper IUD
- •Sexual abstinence is acceptable if consistent with subject's preferred lifestyle
- •Male subjects:
- •Must agree to use condom plus effective contraception if partner is of childbearing potential
- •Must refrain from sperm donation from enrollment through 6 months post-CAR-T infusion
排除标准
- •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
- •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
- •Autoimmune Disease:
- •Active autoimmune disease requiring systemic immunosuppression >15 mg/day prednisone equivalent within past 6 months
- •Examples: rheumatoid arthritis, lupus
研究者
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