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Clinical Trials in China / NCT05995015
Starting soon Phase 1

4SCAR19U T Cells Targeting B Cell Malignancies

NCT05995015 · tracked via the Priya Life Science China tracker
Sponsor
Shenzhen Geno-Immune Medical Institute
Phase
Phase 1
Started
2026-12-31
Last updated
2026-10-30

Condition(s) studied

B Cell Malignancies

Investigational drug(s) / intervention(s)

Universal CD19-specific CAR gene-engineered T cells

Universal CD19-specific CAR gene-engineered T cells: Infusion of 4SCAR19U cells

Study summary

The purpose of this study is to assess the feasibility, safety and efficacy of universal CAR T cell therapy against CD19-positive hematological malignancies using a novel CD19-specific CAR T cell product, 4SCAR19U T cells. The study also aims to learn more about the function of the 4SCAR19U T cells and their persistence in patients. This is a phase I trial enrolling patients from multiple clinical centers.

Eligibility

Sex
ALL
Min age
6 Months
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age older than 6 months. 2. Primary B cell surface expression of CD19. 3. The KPS score over 80 points, and survival time is more than 1 month. 4. Greater than Hgb 80 g/L. 5. No contraindications to blood cell collection. Exclusion Criteria: 1. Accompanied with other active diseases, and difficult to assess response after treatment. 2. Bacterial, fungal, or viral infection, unable to control. 3. Living with HIV. 4. Active HBV or HCV infection. 5. Pregnant and nursing mothers. 6. under systemic steroid treatment within a week of the treatment. 7. Prior failed CAR-T treatment.

Primary outcome measure(s)

  • Safety of 4SCAR19U CAR-T cells infusion — 24 weeks
    Safety of 4SCAR19U T cells in patients with relapsed and refractory B-ALL, BCL using CTCAE 4 standard to evaluate the level of adverse events

Trial sites (1)

FacilityCityRegionStatus
Shenzhen Geno-Immune Medical Institute Shenzhen Guangdong

More Shenzhen Geno-Immune Medical Institute trials in China

PSMA-specific CAR-T Cell Therapy Starting soon
Multi-CAR T Cell Therapy Targeting CD7-positive Malignancies Starting soon
CAR-T Cells Targeting Autoimmune Diseases Starting soon
CD19/22 Bi-specific CAR-T Cell Therapy Starting soon
Combination Immunotherapy Targeting Sarcomas Starting soon

Other trials for the same condition

CD19/22 Bi-specific CAR-T Cell Therapy Starting soon
CD19/70 Bi-specific CAR-T Cell Therapy Starting soon
Study to Evaluate Adverse Events and Change in Disease Activity in Adult Participants With B-Cell Malignancies Receiving Oral ABBV-525 Tablets Active, not recruiting
Anti-CD19-CAR-T Cells in Relapsed/Refractory B-cell Tumor Patients. Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05995015 on ClinicalTrials.gov ↗ ← All trials in China