CD19/22 Bi-specific CAR-T Cell Therapy

NCT05432882 · tracked via the Priya Life Science China tracker

Sponsor

Shenzhen Geno-Immune Medical Institute

Phase

Phase 1/2

Started

2027-06-01

Last updated

2026-08-26

Condition(s) studied

B Cell Malignancies

Investigational drug(s) / intervention(s)

bi-4SCAR CD19/22 T cells

bi-4SCAR CD19/22 T cells: Infusion of bi-4SCAR CD19/22 T cells at 10\^6 cells/kg body weight via IV

Study summary

The purpose of this study is to assess the feasibility, safety and efficacy of anti-CD19/22 bi-specific CAR-T cell therapy in patients with CD19 and/or CD22 positive B cell malignancies. Another goal of the study is to learn more about the safety and function of the anti-CD19/22 bi-specific CAR-T cells and their persistency in patients.

Eligibility

Sex

ALL

Min age

6 Months

Max age

75 Years

Healthy volunteers

Inclusion Criteria: 1. age older than 6 months. 2. malignant B cell surface expression of CD19 or CD22 molecules. 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 patient response. 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 CD19 and CD22 CAR-T treatment.

Primary outcome measure(s)

Safety of fourth generation bi-4SCARCD19/22 T cells in patients with B cell malignancies — 24 weeks
Safety of fourth generation bi-4SCARCD19/22 T cells in patients with B cell malignancies using CTCAE 4 standard to evaluate the level of adverse events standard to evaluate the level of adverse events

Trial sites (1)

Facility	City	Region	Status
Shenzhen Geno-immune Medical Institute	Shenzhen	Guangdong

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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 NCT05432882 on ClinicalTrials.gov ↗ ← All trials in China