CD19/22 Bi-specific CAR-T Cell Therapy

Recruiting now · Phase 1/Phase 2

Conditions studied: B Cell Malignancies

In brief

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.

Key facts

Study ID

NCT05432882

Run by

Shenzhen Geno-Immune Medical Institute

People needed

60

Starts

2026-06-01

Expected to finish

2030-12-31

Last updated by the study team

2026-06-23

Who can join

Age: 1 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• age older than 6 months.
• malignant B cell surface expression of CD19 or CD22 molecules.
• the KPS score over 80 points, and survival time is more than 1 month.
• greater than Hgb 80 g/L.5. no contraindications to blood cell collection.

You may not qualify if…

• accompanied with other active diseases and difficult to assess patient response.
• bacterial, fungal, or viral infection, unable to control.
• living with HIV.4. active HBV or HCV infection.
• pregnant and nursing mothers. 6. under systemic steroid treatment within a week of the treatment. 7. prior failed CD19 and CD22 CAR-T treatment.

Where it is running

• Shenzhen Geno-immune Medical Institute — Shenzhen, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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