Status:
NOT_YET_RECRUITING
A Single-arm Single-center Trial of Bridging GPRC5D/CD3 Bispecific Antibody Treatment With BCMA CAR-T Cell Therapy for Relapsed/Refractory Multiple Myeloma
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Conditions:
Relapsed/Refractory Multiple Myeloma (RRMM)
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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 ≤3.
- 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).
- Reproductive requirements: Non-childbearing women eligible; Childbearing potential women: Negative serum/urine pregnancy test (β-hCG) at screening.
- Contraception: Males/females of reproductive potential must use effective contraception (per investigator judgment) during treatment and for ≥3 months post CAR-T infusion.
- Sperm donation prohibition: Males must refrain from sperm donation from screening until 90 days post-treatment.
- Compliance: Willing and able to complete study procedures and follow-up.
Exclusion
- 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.
Key Trial Info
Start Date :
September 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2028
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT07185477
Start Date
September 15 2025
End Date
May 31 2028
Last Update
September 22 2025
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