RecruitingPhase ITM20260016In situ (in vivo) CAR-T cell therapy targeting multiple targets including BCMA/GPRC5D/DLL3/FcRH5

In situ CAR-T cell therapy targeting multiple… · relapsed/refractory multiple myeloma Phase I clinical trial

Official protocol title:A Phase I Study of In Vivo CAR-T Therapy for Advanced Malignant Tumors (Multiple Myeloma, Lymphoma, Leukemia, Solid Tumors)

Sponsor: Shenzhen Pregene Biopharma Co., Ltd.Updated: 9/3/2026
Target CohortRelapsed/refractory(Synthesized by CMDN from protocol summary; final eligibility confirmed by study doctors)

Trial Summary

This Phase I study sponsored by Shenzhen Pregene Biopharma Co., Ltd. enrolls patients with advanced malignancies, including relapsed/refractory multiple myeloma, whose standard treatment has failed. Participants receive a single intravenous infusion of investigational V001, an in vivo CAR-T approach designed to generate CAR-T cells in the body; the protocol describes administration without ex vivo cell manufacturing or lymphodepleting conditioning. Led by Cancer Hospital, Chinese Academy of Medical Sciences, the study is intended to evaluate safety, tolerability, and preliminary antitumor activity. Clinical benefit has not been established.

Participating Centers0 in China + 1 overseas

Cancer Hospital, Chinese Academy of Medical Sciences

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
Study document (original 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 years, ECOG performance status ≤ 2. The study specifies 14 inclusion and 8 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 [In situ (in vivo) CAR-T cell therapy targeting multiple targets including BCMA/GPRC5D/DLL3/FcRH5]. 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 [Phase I] 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. The lead institution is [Cancer Hospital, Chinese Academy of Medical Sciences]. Prominent sites include Cancer Hospital, Chinese Academy of Medical Sciences. 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 [TM20260016] (OTHER). Patients and researchers can verify registration and ethical authorizations directly through the study hospital ethics committee or designated registry.

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

Phase I

Target / Therapy

In situ (in vivo) CAR-T cell therapy targeting multiple targets including BCMA/GPRC5D/DLL3/FcRH5

Sponsor

Shenzhen Pregene Biopharma Co., Ltd.

Lead Institution

Cancer Hospital, Chinese Academy of Medical Sciences

Participating Centers

0 in China + 1 overseas

Study ID

TM20260016

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

Browse comparable active studies by disease stage, modality and province

Keywords

Shenzhen PRG Biopharmaceutical Co.Ltd.Phase Imultiple myelomaadvanced malignant tumorsBCMAGPRC5DDLL3in situ in vivo CAR-T cellsV001TM20260016

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