RecruitingPhase 1Phase 2NCT05432882

CD19/22 Bi-specific CAR-T Cell Therapy

CD19/22 Bi-specific CAR-T Cells Targeting B Cell Malignancies


Sponsor

Shenzhen Geno-Immune Medical Institute

Enrollment

60 participants

Start Date

Jun 30, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 6 MonthsMax Age: 75 Years

Inclusion Criteria4

  • 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.

Exclusion Criteria4

  • 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.

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Interventions

BIOLOGICALbi-4SCAR CD19/22 T cells

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


Locations(1)

Shenzhen Geno-immune Medical Institute

Shenzhen, Guangdong, China

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NCT05432882


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