NCT07185477尚未招募1 期
A Single-arm Single-center Trial of Bridging GPRC5D/CD3 Bispecific Antibody Treatment With BCMA CAR-T Cell Therapy for Relapsed/Refractory Multiple Myeloma
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
This study is a prospective, single-arm, multicenter trial designed to evaluate the hematologic response rate and safety of GPRC5D/CD3 bispecific antibody bridging therapy prior to CAR-T cell infusion in patients with relapsed/refractory multiple myeloma (RRMM).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Voluntary Participation: Ability to understand and voluntarily sign the informed consent form (ICF).
- •Age ≥18 years.
- •Confirmed symptomatic MM diagnosis per the Chinese Guidelines for Diagnosis and Management of Multiple Myeloma (2022 Revision).
- •Relapsed/Refractory MM (RRMM) meeting one of the following:
- •Triple-class refractory RRMM: Resistant to ≥1 immunomodulatory drug (IMiD), ≥1 proteasome inhibitor (PI), and ≥1 anti-CD38 monoclonal antibody.
- •Penta-drug refractory RRMM: Resistant to ≥2 IMiDs, ≥2 PIs, and ≥1 anti-CD38 antibody.
- •Secondary plasma cell leukemia (sPCL):
- •MM diagnosis per Chinese Guidelines (2022), plus Peripheral blood plasma cells ≥20% of leukocytes or absolute circulating plasma cells >2×10⁹/L.
- •Successful apheresis for CAR-T cell manufacturing.
- •ECOG performance status ≤
- •No active infections:
- •HBV-DNA negative, HCV-RNA negative, HIV negative.
- •Liver function:
- •Total bilirubin <1.5×ULN (<3×ULN for Gilbert's syndrome). AST/ALT <3×ULN.
- •Renal function: Calculated CrCl ≥30 mL/min (Cockcroft-Gault formula).
- •Baseline oxygen saturation >92% (room air).
- •Hematologic criteria (within 7 days of screening):
- •WBC ≥1.0×10⁹/L, ANC ≥1.0×10⁹/L, hemoglobin ≥70 g/L, and Platelets ≥75×10⁹/L (or ≥50×10⁹/L if bone marrow plasma cells ≥50%). Investigator discretion permitted for clinical justification. 12.Growth factor restrictions: 2-week washout required for erythropoietin, G-CSF, GM-CSF, or thrombopoietin agonists (e.g., eltrombopag).
- •13.Reproductive requirements: Non-childbearing women eligible; Childbearing potential women: Negative serum/urine pregnancy test (β-hCG) at screening.
- •14.Contraception: Males/females of reproductive potential must use effective contraception (per investigator judgment) during treatment and for ≥3 months post CAR-T infusion.
- •15.Sperm donation prohibition: Males must refrain from sperm donation from screening until 90 days post-treatment.
- •16.Compliance: Willing and able to complete study procedures and follow-up.
排除标准
- •Prior GPRC5D-targeted immunotherapy.
- •Investigator-assessed contraindications to GPRC5D×CD3 bispecific antibody therapy (e.g., severe cardiopulmonary diseases incompatible with treatment).
- •Grade >2 peripheral neuropathy or ≥grade 2 painful neuropathy at screening (regardless of current medication).
- •Known intolerance, hypersensitivity, or contraindication to GPRC5D×CD3 bispecific antibody components.
- •Initiation of bridging therapy for BCMA CAR-T cell treatment.
- •Unstable/active cardiovascular or cerebrovascular disease, including any of:
- •Unstable angina, symptomatic myocardial ischemia, myocardial infarction, or coronary revascularization within 180 days prior to first dose.
- •Uncontrolled hypertension (>140/90 mmHg with historical readings >180/100 mmHg within 6 months).
- •Clinically significant uncontrolled arrhythmias (excluded: asymptomatic 1st-degree AV block or LAFB/RBBB).
- •LVEF <40% by echocardiography.
- •Stroke or intracranial hemorrhage within 12 months before screening.
- •Pre-treatment severe thrombotic events.
- •Active HIV infection or seropositivity.
- •Active HBV/HCV infection:
- •HBV: HBsAg(+) requires confirmed negative HBV-DNA PCR (allowed: if on antiviral therapy with confirmed suppression).
- •HCV: HCV Ab(+) requires negative HCV-RNA PCR.
- •Pregnancy or lactation.
- •Active gastrointestinal disorders affecting swallowing or drug absorption.
- •Major surgery within 2 weeks pre-enrollment or planned during study (excluded: kyphoplasty/vertebroplasty; allowed: local anesthesia procedures).
- •Live vaccines within 4 weeks before first study dose.
- •Active psychiatric/medical conditions impairing compliance/consent capacity per investigator judgment.
- •Contraindications to required concomitant medications/supportive care.
- •Any condition interfering with study procedures.
- •Inability/unwillingness to comply with protocol.
研究组 & 干预措施
QLS32015
Experimental
干预措施: QLS32015 (Biological)
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: Minimum 2 years after infusion
The proportion of subjects achieving stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR) after treatment with QLS32015 injection
Safety and Tolerability
时间窗: Minimum 2 years after infusion
The incidence of treatment-emergent adverse events (TEAES)
次要结局
- Time to Response (TTR)(Minimum 2 years after infusion)
- Duration of Response (DOR)(Minimum 2 years after infusion)
- Overall Survival (OS)(Minimum 2 years after infusion)
- Progression-Free Survival (PFS)(Minimum 2 years after infusion)
研究者
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