A Single-arm Single-center Trial of Bridging GPRC5D/CD3 Bispecific Antibody Treatment With BCMA CAR-T Cell Therapy for Relapsed/Refractory Multiple Myeloma

NCT07185477 | Not Yet Recruiting Early Phase 1

• 2 other identifiers: IIT2025080Qilu Pharmaceutical Co., Ltd.
• Study Type: interventional
• Target: 20
• 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 GPRC5D/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 QLS32015 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)

QLS32015

EXPERIMENTAL

Biological: QLS32015

Interventions

QLS32015 BIOLOGICAL

QLS32015 is a GPRC5D × CD3 bispecific antibody.

QLS32015

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).
• 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).

You may not qualify if:

• 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).

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

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 22, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2028
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share