RecruitingPhase 1Phase 2NCT05436509

CD19/79b Bi-specific CAR-T Cell Therapy

CD19/79b 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 CD19/79b bi-specific CAR-T cell therapy in patients with CD19 and/or CD79b positive B cell malignancies. Another goal of the study is to learn more about the safety and function of the anti-CD19/79b bi-specific CAR-T cells and their persistency in patients.


Eligibility

Min Age: 6 MonthsMax Age: 75 Years

Inclusion Criteria5

  • age older than 6 months.
  • malignant B cell surface expression of CD19 or CD79b molecules.
  • the KPS score over 80 points, and survival time is more than 1 month.
  • greater than Hgb 80 g/L.
  • no contraindications to blood cell collection.

Exclusion Criteria7

  • accompanied with other active diseases and difficult to assess patient response.
  • bacterial, fungal, or viral infection, unable to control.
  • living with HIV.
  • active HBV or HCV infection.
  • pregnant and nursing mothers.
  • under systemic steroid treatment within a week of the treatment.
  • prior failed CD19 and CD79b CAR-T treatment.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALbi-4SCAR CD19/79b T cells

Infusion of bi-4SCAR-CD19/79b T cells at 10\^6 cells/kg body weight via IV


Locations(1)

Shenzhen Geno-immune Medical Institute

Shenzhen, Guangdong, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05436509


Related Trials