RecruitingPhase 1Phase 2NCT03050190

A Phase I/II Multiple Center Trial of 4SCAR19 Cells in the Treatment of Relapsed and Refractory B Cell Malignancies


Sponsor

Shenzhen Geno-Immune Medical Institute

Enrollment

200 participants

Start Date

May 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The study will evaluate safety and efficacy of a 4th generation chimeric antigen receptor gene-modified T cells targeting CD19 (4SCAR19) for patients with B cell malignancies. Clinical response and development of a standardized lentiviral vector and cell production protocol will be investigated. This is a phase I/II trial enrolling patients from multiple clinical centers.


Eligibility

Min Age: 6 Months

Plain Language Summary

Simplified for easier understanding

This trial tests a CAR T-cell therapy — where a patient's own immune cells are reprogrammed in a lab to recognize and attack cancer — in people with B-cell blood cancers (a type of cancer affecting white blood cells) that have come back or not responded to other treatments. **You may be eligible if...** - You are older than 6 months - Your cancer cells have a marker called CD19 on their surface (this is a type of B-cell cancer) - You are in reasonably good health overall (KPS score over 80) with a life expectancy of more than 3 months - Your hemoglobin (red blood cell level) is above 80 g/L **You may NOT be eligible if...** - You have another serious active disease that cannot be controlled - You have an active bacterial, fungal, or viral infection that is not controlled - You are HIV positive - You have active hepatitis B or C - You are pregnant or breastfeeding - You took systemic steroid medications (like prednisone) within the past week - You have already tried CAR T-cell therapy and it did not work Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

GENETICTherapeutic 4SCAR19 cells

Autologous 4th generation withdrawal lentiviral-transduced 4S CAR-T19


Locations(2)

Shenzhen Geno-immune Medical Institute

Shenzhen, Guangdong, China

The First People's Hospital of Yunnan

Kunming, Yunnan, China

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NCT03050190


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