RecruitingPhase 1Phase 2NCT03125577

Combination CAR-T Cell Therapy Targeting Hematological Malignancies

Combination CAR-T Therapy of 4SCAR19 Plus 4SCAR20, 22, 38, 70 and 123 Targeting Hematological Malignancies


Sponsor

Shenzhen Geno-Immune Medical Institute

Enrollment

100 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The study will evaluate safety and efficacy of a combination of 4th generation chimeric antigen receptor gene-modified T cells targeting CD19 (4SCAR19) and CD20 (4SCAR20), CD22 (4SCAR22), CD30 (4SCAR30), CD38 (4SCAR38), CD70 (4SCAR70) or CD123 (4SCAR123) for patients with B cell malignancies. Clinical response and development of a standardized lentiviral vector and cell production protocol will be investigated. This is a phase I/II trial enrolling patients from multiple clinical centers.


Eligibility

Min Age: 6 MonthsMax Age: 75 Years

Inclusion Criteria5

  • age older than 6 months.
  • malignant B cell surface expression of CD19/CD20/CD22/CD30/CD38/CD70/CD123 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, the treatment is difficult to assess patient response.
  • bacteria, fungus, or virus infection, unable to control.
  • living with HIV.
  • active HBV and HCV infection.
  • pregnant and nursing mothers.
  • under systemic steroid treatment within a week of the treatment.
  • prior failed CAR-T treatment.

Interventions

BIOLOGICAL4SCAR19 and 4SCAR22

4SCAR19 and 4SCAR22

BIOLOGICAL4SCAR19 and 4SCAR38

4SCAR19 and 4SCAR38

BIOLOGICAL4SCAR19 and 4SCAR20

4SCAR19 and 4SCAR20

BIOLOGICAL4SCAR19 and 4SCAR123

4SCAR19 and 4SCAR123

BIOLOGICAL4SCAR19 and 4SCAR70

4SCAR19 and 4SCAR70

BIOLOGICAL4SCAR19 and 4SCAR30

4SCAR19 and 4SCAR30


Locations(4)

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Shenzhen Geno-immune Medical Institute

Shenzhen, Guangdong, China

Yunnan Cancer Hospital & The Third Affiliated Hospital of Kunming Medical University & Yunnan Cancer Center

Kunming, Yunnan, China

View Full Details on ClinicalTrials.gov

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NCT03125577


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