Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT03919240

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Acute Lymphoblastic Leukemia With Failed Remission Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Precursor Cell Lymphoblastic Leukemia-Lymphoma Recurrence

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The Fisrt Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

CAR T-cell therapy

Biological

All enrolled patients will initially enter Arm A and receive CD19-targeted CAR T-cell therapy at a target dose of 5~10×10E6 cells/kg after a lymphodepleting regimen consisting of fludarabine (30 mg/m²/day, days -5 to -3) and cyclophosphamide (300 mg/m²/day, days -5 to -3). Patients with an available eligible donor who consent to randomization will enter the RCT component and be randomized in a 2:1 ratio to Arm B1 (CAR T-cell therapy alone) or Arm B2 (CAR T-cell therapy followed by allo-HCT); all other patients will remain in Arm A.

Primary outcomes

  1. Completeremission

    Time frame: 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

  2. Minimal residual disease response

    Time frame: 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

  3. Leukemia-free survival

    Time frame: 3 year post infusion

    calculating from the day of CAR T-cell infusion to death, disease progression or the end of follow-up

Secondary outcomes

  1. Overall survival

    Time frame: 3 year post infusion

    calculating from the day of CAR T-cell infusion to death or the end of follow-up

  2. Cumulative incidence of relapse

    Time frame: 3 year post infusion

    calculating from the day of CAR T-cell infusion to disease progression or the end of follow-up

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Soochow University

Other

Collaborators

  • Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
  • The Second People's Hospital of Huai'an
  • Third Military Medical University

Registry information

Official study title

CD19-targeting Chimeric Antigen Receptor T-cell Therapy for Patients With Refractory and Relapsed B-cell Acute Lymphoblastic Leukemia

Important dates

Study start
2015
Primary completion
2027
Study completion
2027
First posted
Apr 18, 2019
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.