NCT03919240Active, not recruitingPhase 1/2
CAR-T Cell Therapy Targeting to CD19 for R/R ALL
CD19-targeting Chimeric Antigen Receptor T-cell Therapy for Patients With Refractory and Relapsed B-cell Acute Lymphoblastic Leukemia
Source: ClinicalTrials.gov · Last updated 4 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 196 (estimated)
- First submitted
- 15 Apr 2019
- Start date
- 1 Dec 2015
- Primary completion date
- 30 Aug 2027
- Lead sponsor
- The First Affiliated Hospital of Soochow University
- NCT number
- NCT03919240
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 196
- From 1 Dec 2015 to the primary completion date, 30 Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- With active infection or other uncontrolled complications;
- With history of seizure;
- Active hepatitis B or hepatitis C infection and HIV infection;
Other
- Intolerant to immunosuppressive chemotherapies;
- Pregnant or lactating women, or patients refusing to take effective contraception measures;
- Other contraindications that considered inappropriate to participate in this trial (according to investigator's judgement).
Who the study is looking for
- Diagnosed as CD19+ B-cell acute lymphoblastic leukemia;
- Fail to achieve remission, or with persistent residual disease after at least 2 cycles of consolidation;
- With an estimated survival of higher than 3 months (according to investigator's judgement);
- Sufficient organ function: left ventricular ejection fractions≥ 0.5 by echocardiography, creatinine \< 1.6 mg/dL, aspartate aminotransferase/aspartateaminotransferase \< 3 x upper limit of normal, bilirubin \<2.0 mg/dL;
- Karnofsky performance status ≥ 60 or ECOG ≤ 2.
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Fisrt Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.