Actively Recruiting

Phase 1
Age: 6Months - 75Years
All Genders
NCT05995015

4SCAR19U T Cells Targeting B Cell Malignancies

Led by Shenzhen Geno-Immune Medical Institute · Updated on 2023-10-12

30

Participants Needed

1

Research Sites

165 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this study is to assess the feasibility, safety and efficacy of universal CAR T cell therapy against CD19-positive hematological malignancies using a novel CD19-specific CAR T cell product, 4SCAR19U T cells. The study also aims to learn more about the function of the 4SCAR19U T cells and their persistence in patients. This is a phase I trial enrolling patients from multiple clinical centers.

CONDITIONS

Official Title

4SCAR19U T Cells Targeting B Cell Malignancies

Who Can Participate

Age: 6Months - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age older than 6 months
  • Primary B cell surface expression of CD19
  • Karnofsky Performance Status (KPS) score over 80 points
  • Expected survival time more than 1 month
  • Hemoglobin level greater than 80 g/L
  • No contraindications to blood cell collection
Not Eligible

You will not qualify if you...

  • Presence of other active diseases making treatment response hard to assess
  • Uncontrolled bacterial, fungal, or viral infections
  • Living with HIV
  • Active hepatitis B or C infection
  • Pregnant or nursing mothers
  • Systemic steroid treatment within one week prior to treatment
  • Previous failed CAR-T cell therapy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Shenzhen Geno-Immune Medical Institute

Shenzhen, Guangdong, China, 518000

Actively Recruiting

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Research Team

L

Lung-Ji Chang, Ph.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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