Actively Recruiting

Phase 1
Phase 2
All Genders
NCT03919240

CAR-T Cell Therapy Targeting to CD19 for R/R ALL

Led by The First Affiliated Hospital of Soochow University · Updated on 2026-04-21

196

Participants Needed

1

Research Sites

630 weeks

Total Duration

On this page

Sponsors

T

The First Affiliated Hospital of Soochow University

Lead Sponsor

S

Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd

Collaborating Sponsor

AI-Summary

What this Trial Is About

Refractory and relapsed (R/R) acute lymphoblastic leukemia (ALL) patients with active disease always have a dismal outcome. Chimeric antigen receptor (CAR) T-cell therapy targeting to Cluster of Differentiation Antigen 19 (CD19) has been proved as a potent approach to attain remission in B-cell R/R patients. Therefore, the investigators conduct atrial to evaluate the the efficacy and safety of locally producing CAR T cells targeting CD19, and to analyze the outcome of enrolled B-cell ALL patients with active disease or persistent residual disease.

CONDITIONS

Official Title

CAR-T Cell Therapy Targeting to CD19 for R/R ALL

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed as CD19+ B-cell acute lymphoblastic leukemia
  • Failed to achieve remission or have persistent residual disease after at least 2 cycles of consolidation
  • Estimated survival longer than 3 months as judged by investigator
  • Sufficient organ function: left ventricular ejection fraction 6 0.5 by echocardiography, creatinine < 1.6 mg/dL, liver enzymes < 3 times upper limit of normal, bilirubin < 2.0 mg/dL
  • Karnofsky performance status 6 60 or ECOG status 4 2
Not Eligible

You will not qualify if you...

  • Intolerant to immunosuppressive chemotherapies
  • Active infection or other uncontrolled complications
  • History of seizure
  • Active hepatitis B or C infection or HIV infection
  • Pregnant or breastfeeding women, or patients not using effective contraception
  • Other contraindications considered inappropriate by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

The Fisrt Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China, 215006

Actively Recruiting

Loading map...

Research Team

J

Jia Chen, M.D., Ph.D.

CONTACT

X

Xiang Zhang, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here