RecruitingPhase INCT07620314CD19, BCMAIIT Study

CD19, BCMA · relapsed/refractory multiple myeloma Phase I clinical trial

Official protocol title:An Early Exploratory Clinical Study of the Safety and Efficacy of KSVCBD Injection in the Treatment of CD19- and/or BCMA-Positive B-Cell Malignancies

Sponsor: Chinese PLA General Hospital (301 Hospital)Lead: Chinese PLA General Hospital (301 Hospital)Updated: 9/4/2026
Target CohortRelapsed/refractory(Synthesized by CMDN from protocol summary; final eligibility confirmed by study doctors)

Trial Summary

This study is an early exploratory clinical trial evaluating the safety and preliminary efficacy of KSVCBD injection in the treatment of CD19- and/or BCMA-positive B-cell malignancies. The study primarily enrolls pathologically confirmed and eligible patients aged 18 to 75 years with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL) or relapsed/refractory multiple myeloma (RRMM). Enrolled participants will receive a single intravenous infusion of KSVCBD injection, followed by long-term safety and efficacy follow-up monitoring. The trial is currently being conducted by and recruiting at the Department of Biotherapy, Chinese PLA General Hospital (301 Hospital).

Participating Centers0 in China + 1 overseas

Chinese PLA General Hospital (301 Hospital)

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
2026-09-04
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 18–75 years, ECOG performance status ≤ 2, ≥ 3 prior lines of therapy. The study specifies 10 inclusion and 22 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 [CD19, BCMA]. 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 [Chinese PLA General Hospital (301 Hospital)]. Prominent sites include Chinese PLA General Hospital (301 Hospital). 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 [NCT07620314] (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

Phase I

Target / Therapy

CD19, BCMA

Sponsor

Chinese PLA General Hospital (301 Hospital)

Principal Investigator

Weidong Han

Lead Institution

Chinese PLA General Hospital (301 Hospital)

Participating Centers

0 in China + 1 overseas

ClinicalTrials.gov ID

NCT07620314

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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Keywords

KSVCBD injectionCAR-TCD19BCMAB-cell non-Hodgkin lymphomamultiple myeloma

Considering a non-trial option?

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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.

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