NCT03919240

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
196

participants targeted

Target at P75+ for phase_1

Timeline
20mo left

Started Dec 2015

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Dec 2015Dec 2027

Study Start

First participant enrolled

December 1, 2015

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

April 15, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 18, 2019

Completed
8.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

11.8 years

First QC Date

April 15, 2019

Last Update Submit

April 16, 2026

Conditions

Acute Lymphoblastic Leukemia With Failed Remission

Keywords

Acute Lymphoblastic LeukemiaRefractory and relapsedChimeric antigen receptor T-cell therapy

Outcome Measures

Primary Outcomes (3)

  • Completeremission

    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

    1 month post infusion

  • Minimal residual disease response

    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

    1 month post infusion

  • Leukemia-free survival

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

    3 year post infusion

Secondary Outcomes (2)

  • Overall survival

    3 year post infusion

  • Cumulative incidence of relapse

    3 year post infusion

Study Arms (1)

CAR T-cell therapy

EXPERIMENTAL

Patients enrolled will receive infusion of CD19-targeting CART-cells

Biological: CAR T-cell therapy

Interventions

CAR T-cell therapyBIOLOGICAL

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.

CAR T-cell therapy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Fisrt Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

RECRUITING

Related Publications (4)

  • Lee DW, Gardner R, Porter DL, Louis CU, Ahmed N, Jensen M, Grupp SA, Mackall CL. Current concepts in the diagnosis and management of cytokine release syndrome. Blood. 2014 Jul 10;124(2):188-95. doi: 10.1182/blood-2014-05-552729. Epub 2014 May 29.

    PMID: 24876563BACKGROUND

  • Liu S, Zhang X, Dai H, Cui W, Yin J, Li Z, Yang X, Yang C, Xue S, Qiu H, Miao M, Chen S, Jin Z, Fu C, Li C, Sun A, Han Y, Wang Y, Yu L, Wu D, Cui Q, Tang X. Which one is better for refractory/relapsed acute B-cell lymphoblastic leukemia: Single-target (CD19) or dual-target (tandem or sequential CD19/CD22) CAR T-cell therapy? Blood Cancer J. 2023 Apr 24;13(1):60. doi: 10.1038/s41408-023-00819-5.

    PMID: 37095120DERIVED

  • Li M, Xue SL, Tang X, Xu J, Chen S, Han Y, Qiu H, Miao M, Xu N, Tan J, Kang L, Yu Z, Lou X, Xu Y, Chen J, Yan Z, Feng W, Wu D, Yu L. The differential effects of tumor burdens on predicting the net benefits of ssCART-19 cell treatment on r/r B-ALL patients. Sci Rep. 2022 Jan 10;12(1):378. doi: 10.1038/s41598-021-04296-3.

    PMID: 35013456DERIVED

  • Liu ZF, Chen LY, Wang J, Kang LQ, Tang H, Zhou Y, Zhou HX, Sun AN, Wu DP, Xue SL. Successful treatment of acute B lymphoblastic leukemia relapse in the skin and testicle by anti-CD19 CAR-T with IL-6 knocking down: a case report. Biomark Res. 2020 May 6;8:12. doi: 10.1186/s40364-020-00193-5. eCollection 2020.

    PMID: 32399214DERIVED

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-LymphomaRecurrence

Interventions

Immunotherapy, Adoptive

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Adoptive TransferImmunization, PassiveImmunizationImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative Techniques

Study Officials

  • Depei Wu, M.D., Ph.D.

    The First Affiliated Hospital of Soochow University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

+86 512 67781856drchenjia@163.com

Xiang Zhang, M.D.

CONTACT

+86 512 67781856lcsy2013@sina.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2019

First Posted

April 18, 2019

Study Start

December 1, 2015

Primary Completion (Estimated)

August 30, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

April 21, 2026

Record last verified: 2026-04

Locations

CN(1)