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BCMA/GPRC5D Trispecific Antibody Treatment for Newly Diagnosed Amyloidosis (AL-004)

NCT07751471 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-08-07

No results posted yet for this study

Summary

Systemic light-chain (AL) amyloidosis is a plasma cell disorder characterized by the production of misfolded immunoglobulin light chains that deposit in organs and lead to progressive organ dysfunction. Although daratumumab-based therapy has improved outcomes, a substantial proportion of patients fail to achieve deep hematologic responses.

This is a prospective, single-arm, single-center clinical study evaluating the safety and efficacy of the BCMA/GPRC5D/CD3 trispecific antibody QLS4131 in patients with newly diagnosed systemic AL amyloidosis.

Conditions

  • AL Amyloidosis

Interventions

DRUG

QLS4131

QLS4131 is an investigational GPRC5D/BCMA/CD3 trispecific antibody administered by subcutaneous injection. The study uses a step-up dosing schedule followed by full-dose maintenance treatment over 6 to 8 treatment cycles. Supportive care and prophylactic medications for cytokine release syndrome (CRS) are permitted according to the study protocol.

Sponsors & Collaborators

  • Institute of Hematology & Blood Diseases Hospital, China

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-20
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07751471 on ClinicalTrials.gov