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

Primary Purpose

Acute Lymphoblastic Leukemia With Failed Remission

Status

Recruiting

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

CAR T-cell therapy

About this trial

This is an interventional treatment trial for Acute Lymphoblastic Leukemia With Failed Remission focused on measuring Acute Lymphoblastic Leukemia, Refractory and relapsed, Chimeric antigen receptor T-cell therapy

Eligibility Criteria

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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/aspartate aminotransferase < 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).

Sites / Locations

The Fisrt Affiliated Hospital of Soochow UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CAR T-cell therapy

Arm Description

Patients enrolled will receive infusion of CD19-targeting CAR T-cells

Outcomes

Primary Outcome Measures

Complete remission

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

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

Cytokine release syndrome

grading according to the criteria proposed by Lee, et al (Blood, 2014, 124: 188-195). This grading system ranges from grade 1 (best) to grade 5 (worst), by measuring related symptoms (such as fever, nausea, fatigue, headache, etc.), oxygen requirement, blood pressure and organ toxicity (referred to CTCAE v4.0 grading)

Secondary Outcome Measures

Overall survival

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

Leukemia-free survival

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

Cumulative incidence of relapse

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

Full Information

NCT ID

NCT03919240

First Posted

April 15, 2019

Last Updated

June 29, 2020

Sponsor

The First Affiliated Hospital of Soochow University

Collaborators

Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd

1. Study Identification

Unique Protocol Identification Number

NCT03919240

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Recruiting

Study Start Date

December 1, 2015 (Actual)

Primary Completion Date

December 31, 2020 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The First Affiliated Hospital of Soochow University

Collaborators

Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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 a trial 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Lymphoblastic Leukemia With Failed Remission

Keywords

Acute Lymphoblastic Leukemia, Refractory and relapsed, Chimeric antigen receptor T-cell therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CAR T-cell therapy

Arm Type

Experimental

Arm Description

Patients enrolled will receive infusion of CD19-targeting CAR T-cells

Intervention Type

Biological

Intervention Name(s)

CAR T-cell therapy

Intervention Description

Patients enrolled will receive infusion of CD19-targeting CAR T-cells with a target dose of 5~10×10E6/kg of recipient weight, after the preparative regimen consisted of fludarabin (30mg/m2, day -5 to -3) and cyclophosphamide (300mg/m2, day -5 to -3).

Primary Outcome Measure Information:

Title

Complete remission

Description

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

Time Frame

1 month post infusion

Title

Minimal residual disease response

Description

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

Time Frame

1 month post infusion

Title

Cytokine release syndrome

Description

Time Frame

1 month post infusion

Secondary Outcome Measure Information:

Title

Overall survival

Description

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

Time Frame

1 year post infusion

Title

Leukemia-free survival

Description

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

Time Frame

1 year post infusion

Title

Cumulative incidence of relapse

Description

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

Time Frame

1 year post infusion

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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/aspartate aminotransferase < 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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

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

Phone

+86 512 67781856

drchenjia@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Xiang Zhang, M.D.

Phone

+86 512 67781856

lcsy2013@sina.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Depei Wu, M.D., Ph.D.

Organizational Affiliation

The First Affiliated Hospital of Soochow University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Fisrt Affiliated Hospital of Soochow University

City

Suzhou

State/Province

Jiangsu

ZIP/Postal Code

215006

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Depei Wu, M.D., Ph.D.

Phone

+86 512 6778 1856

wudepei@medmail.com.cn

First Name & Middle Initial & Last Name & Degree

Jia Chen, M.D.

Phone

+86 512 6778 1856

chenjia@suda.edu.cn

First Name & Middle Initial & Last Name & Degree

Depei Wu, M.D., Ph.D.

First Name & Middle Initial & Last Name & Degree

Jia Chen, M.D.

First Name & Middle Initial & Last Name & Degree

Aining Sun, M.D., Ph.D.

First Name & Middle Initial & Last Name & Degree

Huiying Qiu, M.D., Ph.D.

First Name & Middle Initial & Last Name & Degree

Xiaowen Tang, M.D., Ph.D.

First Name & Middle Initial & Last Name & Degree

Yue Han, M.D., Ph.D.

First Name & Middle Initial & Last Name & Degree

Zhengming Jin, M.D.

First Name & Middle Initial & Last Name & Degree

Chengcheng Fu, M.D., Ph.D.

First Name & Middle Initial & Last Name & Degree

Feng Chen, M.D., Ph.D.

First Name & Middle Initial & Last Name & Degree

Xiao Ma, M.D., Ph.D.

First Name & Middle Initial & Last Name & Degree

Suning Chen, M.D., Ph.D.

First Name & Middle Initial & Last Name & Degree

Xiang Zhang, M.D.

12. IPD Sharing Statement

Citations:

PubMed Identifier

24876563

Citation

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. Erratum In: Blood. 2015 Aug 20;126(8):1048. Dosage error in article text. Blood. 2016 Sep 15;128(11):1533.

Results Reference

background

PubMed Identifier

35013456

Citation

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.

Results Reference

derived

PubMed Identifier

32399214

Citation

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.

Results Reference

derived

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

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