Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
The Fisrt Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Actively Recruiting
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
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