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

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

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).

Eligibility criteria

Qualifiers

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).

Successful apheresis for CAR-T cell manufacturing.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • QLS32015

Treatment groups

20 Participants
are divided into 1 treatment group

Locations

This trial has no locations