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RecruitingEarly Exploratory Clinical StudyNCT07622862Allogeneic universal CAR-T targeting BCMA/GPRC5DIIT Study

Allogeneic universal CAR-T targeting BCMA/GPRC… · relapsed/refractory multiple myeloma Early Exploratory Clinical Study

Official protocol title:An Early Exploratory Clinical Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of BCMA/GPRC5D Dual-Targeted Allogeneic Universal CAR-T Cell Injection (DQ1001) in Patients with Relapsed or Refractory Multiple Myeloma (RRMM)

Sponsor: Zhongshan Hospital, Xiamen UniversityUpdated: 9/3/2026
Target CohortRelapsed/refractory(Synthesized by CMDN from protocol summary; final eligibility confirmed by study doctors)

Trial Summary

This clinical study is for patients with relapsed or refractory multiple myeloma (RRMM) who have received at least 3 prior lines of therapy. Eligible participants will receive a single intravenous infusion of a universal CAR-T cell product targeting BCMA/GPRC5D (DQ1001) following lymphodepletion preconditioning with fludarabine and cyclophosphamide. This is a single-center, early exploratory study planning to enroll 10 to 16 participants, aiming to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of the drug.

Participating Centers0 in China + 1 overseas

Zhongshan Hospital, Xiamen University

Source and Verification

Every fact on this page is derived from the original filing below. The source document is archived as a PDF for direct verification.

Document type
Clinical trial registry record (archived PDF)
Official registration number
No CDE registration number
Last reconciled
2026-09-03
No public registration number was found on the NMPA Center for Drug Evaluation (CDE) platform for this study. It is typically an investigator-initiated trial or registered only in an international registry. Confirm details directly with the study site.

Frequently Asked Questions about this Study

Structured facts derived from official protocol filings for patient and family reference

QWhich patient group is targeted by this clinical trial?

According to official protocol filings (target population synthesized by CMDN from study details, not an official registry field), this study is primarily designed for patients with [Relapsed/refractory]. Eligibility requires verified clinical confirmation by investigators regarding prior lines of therapy, active disease biomarkers, and performance status.

QWhat are the specific eligibility criteria regarding age, performance status, and prior therapy?

According to verified protocol filings, key eligibility thresholds include: age 18–70 years, ECOG performance status ≤ 2, ≥ 3 prior lines of therapy. The study specifies 11 inclusion and 15 exclusion criteria covering detailed organ function and medical history. Final enrollment confirmation is determined by investigators at participating hospital trial centers.

QWhat are the investigational targets and mechanism of action?

The core therapeutic target or investigational mechanism is [Allogeneic universal CAR-T targeting BCMA/GPRC5D]. It aims to selectively eradicate clonal plasma cells or redirect anti-tumor immune responses, representing an active area of precision hematology research.

QWhat clinical phase is this study in?

This study is registered as a [Early Exploratory Clinical Study] clinical trial. The protocol is conducted under rigorous ethical and Good Clinical Practice (GCP) oversight approved by institutional ethics committees.

QWhere are the participating hospital trial centers located?

This is an international multi-centre study with 0 study centres in China and 1 overseas centres. Prominent sites include Zhongshan Hospital, Xiamen University. Eligible domestic patients can seek screening at the nearest participating centre.

QWhat is the official trial registration code and how can it be verified?

The official public registration identifier for this protocol is [NCT07622862] (CLINICALTRIALS_GOV). Patients and researchers can verify registration details and authorizations on ClinicalTrials.gov.

Note for International Patients: Trial centers for this study are located in China. Interventional trials strictly comply with domestic Human Genetic Resources (HGRAC) regulations and standard hospital protocols, which generally restrict enrollment to residents with domestic healthcare identification. International patients seeking approved cellular therapies should review commercial options.

Key Information

Status

Recruiting

Phase

Early Exploratory Clinical Study

Target / Therapy

Allogeneic universal CAR-T targeting BCMA/GPRC5D

Sponsor

Zhongshan Hospital, Xiamen University

Principal Investigator

Zheng Wei

Participating Centers

0 in China + 1 overseas

ClinicalTrials.gov ID

NCT07622862

Trial information is translated from the Chinese source record and reviewed by CMDN. Confirm current status and eligibility with the study team.

Where this study sits in the landscape

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Relapsed / Refractory Multiple Myeloma (RRMM)CAR-T Cell Therapy

Keywords

multiple myeloma; relapsed or refractory; BCMA; GPRC5D; universal CAR-T; DQ1001

Considering a non-trial option?

International participation must be confirmed directly with the study team. If a clinical trial is not practical, review our independent guide to CAR-T in China.

View CAR-T in China Guide →

Evidence · Process · Costs · Verified hospitals

Patient Rights & Safety Assurance

Protocol drugs and related tests are fully covered by the sponsor. All studies are strictly supervised by ethics committees, and patients retain the legal right to withdraw at any time.

Read application guide & patient rights