BCMA/CD3 Bispecific Antibody as Bridging Therapy Before CAR-T Cell Infusion in RRMM

NCT07407010 | Not Yet Recruiting Phase 1

• 1 other identifier: IIT2024047
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a prospective, single-arm, multicenter trial designed to evaluate the hematologic response rate and safety of BCMA/CD3 bispecific antibody bridging therapy prior to CAR-T cell infusion in patients with relapsed/refractory multiple myeloma (RRMM).

Conditions

Relapsed Refractory Multiple Myeloma (RRMM)

Outcome Measures

Primary Outcomes (2)

• Overall Response Rate (ORR)

  The proportion of subjects achieving stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR) after treatment with CM336 injection

  Minimum 2 years after infusion

• Safety and Tolerability

  The incidence of treatment-emergent adverse events (TEAES)

  Minimum 2 years after infusion

Secondary Outcomes (4)

• 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

Study Arms (1)

CM336

EXPERIMENTAL

Biological: CM336 (BCMA/CD3 bispecific antibody)

Interventions

CM336 (BCMA/CD3 bispecific antibody) BIOLOGICAL

CM336 is a BCMA × CD3 bispecific antibody.

CM336

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary Participation: Ability to understand and voluntarily sign the informed consent form (ICF).2.Age ≥18 years.3.Confirmed symptomatic MM diagnosis per the Chinese Guidelines for Diagnosis and Management of Multiple Myeloma (2022 Revision).4.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), plusPeripheral blood plasma cells ≥20% of leukocytes or absolute circulating plasma cells \>2×10⁹/L.5.Successful apheresis for CAR-T cell manufacturing.6.ECOG performance status ≤3.7.No active infections:HBV-DNA negative, HCV-RNA negative, HIV negative.8.Liver function:Total bilirubin \<1.5×ULN (\<3×ULN for Gilbert's syndrome).AST/ALT \<3×ULN.9.Renal function: Calculated CrCl ≥30 mL/min (Cockcroft-Gault formula).10.Baseline oxygen saturation \>92% (room air).11.Hematologic criteria (within 7 days of screening):WBC ≥1.0×10⁹/L, ANC ≥1.0×10⁹/L, hemoglobin ≥70 g/L, andPlatelets ≥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.

You may not qualify if:

• Prior GPRC5D-targeted immunotherapy.2.Investigator-assessed contraindications to GPRC5D×CD3 bispecific antibody therapy (e.g., severe cardiopulmonary diseases incompatible with treatment).3.Grade \>2 peripheral neuropathy or ≥grade 2 painful neuropathy at screening (regardless of current medication).4.Known intolerance, hypersensitivity, or contraindication to GPRC5D×CD3 bispecific antibody components.5.Initiation of bridging therapy for BCMA CAR-T cell treatment.6.Unstable/active cardiovascular or cerebrovascular disease, including any of:a. Unstable angina, symptomatic myocardial ischemia, myocardial infarction, or coronary revascularization within 180 days prior to first dose.b. Uncontrolled hypertension (\>140/90 mmHg with historical readings \>180/100 mmHg within 6 months).c. Clinically significant uncontrolled arrhythmias (excluded: asymptomatic 1st-degree AV block or LAFB/RBBB).d. LVEF \<40% by echocardiography.e. Stroke or intracranial hemorrhage within 12 months before screening.f. Pre-treatment severe thrombotic events.7.Active HIV infection or seropositivity.8.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.9.Pregnancy or lactation.10.Active gastrointestinal disorders affecting swallowing or drug absorption.11.Major surgery within 2 weeks pre-enrollment or planned during study (excluded: kyphoplasty/vertebroplasty; allowed: local anesthesia procedures).12.Live vaccines within 4 weeks before first study dose.13.Active psychiatric/medical conditions impairing compliance/consent capacity per investigator judgment.14.Contraindications to required concomitant medications/supportive care.15.Any condition interfering with study procedures.16.Inability/unwillingness to comply with protocol.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 12, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2028
• Last Updated: February 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share