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

Phase 1

Active, not recruiting

• Conditions: Acute Lymphoblastic Leukemia with Failed Remission
• Interventions: Biological: CAR T-cell therapy

• Registration Number: NCT03919240
• Lead Sponsor: The First Affiliated Hospital of Soochow University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-01
• Study First Submitted: 2019-04-15
• Study First Submitted QC: 2019-04-15
• Study First Posted: 2019-04-18
• Primary Completion: 2024-08-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-22
• Last Update Posted: 2024-10-24
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 196

Inclusion Criteria

• 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.

Exclusion Criteria

• Intolerant to immunosuppressive chemotherapies;
• With active infection or other uncontrolled complications;
• With history of seizure;
• Active hepatitis B or hepatitis C infection and HIV infection;
• 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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CAR T-cell therapy	CAR T-cell therapy	Patients enrolled will receive infusion of CD19-targeting CART-cells

Primary Outcome Measures

Name	Time	Method
Completeremission	1 month post infusion	defined as less than 5% blasts in the bone marrow without myelosuppression, no circulating blasts in peripheral blood, and the absence of extramedullary disease, regardless of cell count recovery
Minimal residual disease response	1 month post infusion	defined as less than 0.01% bone marrow blasts assessed by multiparameter flow cytometry, and absence of genetic aberrants assessed by karyotype analysis or molecular detection
Leukemia-free survival	3 year post infusion	calculating from the day of CAR T-cell infusion to death, disease progression or the end of follow-up

Secondary Outcome Measures

Name	Time	Method
Overall survival	3 year post infusion	calculating from the day of CAR T-cell infusion to death or the end of follow-up
Cumulative incidence of relapse	3 year post infusion	calculating from the day of CAR T-cell infusion to disease progression or the end of follow-up

Trial Locations

Locations (1)

The Fisrt Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China