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Humanized CD19 CAR-T Cells With CRS Suppression Technology for r/r CD19+ Acute Lymphoblastic Leukemia

Primary Purpose

Acute Lymphoblastic Leukemia, CD19 Positive, Relapse

Status

Recruiting

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Humanized CD19 CAR-T cells

Humanized CD19 CAR-T cells with CRS suppression technology

About this trial

This is an interventional treatment trial for Acute Lymphoblastic Leukemia focused on measuring CD19+ ,CAR-T, CRS

Eligibility Criteria

6 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 6 to 65
Voluntary informed consent is given
Expected survival ≥12 weeks
Relapsed or refractory CD19+ acute leukemia, ineligible for allo-HSCT,or relapse after auto-HSCT
Organ function: (1)Left ventricular ejection fractions≥ 0.6 by echocardiography (2)ALT ≤3 times of ULN, or bilirubin <2.0 mg/dl (3)Creatinine < 2 mg/dl and less than 2.5 × normal for age (4)Prothrombin time and activated partial thromboplastin time < 2 times of ULN (5)Arterial oxygen saturation> 92%
Karnofsky score ≥ 60 ;
No history of combined chemotherapy in the recent 1 month and no immunotherapy in the recent 3 months;

Exclusion Criteria:

Uncontrolled active infections
Active hepatitis B or hepatitis C infection
HIV infection
History of myocardio infarction in the past 6 months, or history of severe arrhythmia
Congenital immunodeficiency
Pregnant or lactating women
History or presence of clinically relevant CNS pathology such as epilepsy, generalized seizure disorder, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis
Previous treatment with any gene therapy products

Sites / Locations

The first affiliated hospital of soochow universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Experimental: Cohort 1

Experimental: Cohort 2

Arm Description

This cohort will determine the safety and efficacy of humanized CD19 CAR-T cells for CD19+ acute lymphoblastic leukemia

This cohort will determine the safety and efficacy of humanized CD19 CAR-T cells with CRS suppression technology for CD19+ acute lymphoblastic leukemia.

Outcomes

Primary Outcome Measures

Incidence of severe CRS

The safety of the humanized CD19 CAR-T cells treatment will be evaluated and the maximum tolerated dose will be determined

Secondary Outcome Measures

Overall response of humanized CD19 CAR-T cells treatment who achieve morphology complete remission(CR) and MRD negativity.

The efficacy of the humanized CD19 CAR-T cells infusion will be estimated based on the number of participants who have morphology complete remission(CR) and MRD negativity following the humanized CD19 CAR- T cells infusion

Full Information

NCT ID

NCT03275493

First Posted

September 5, 2017

Last Updated

May 18, 2022

Sponsor

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

Collaborators

The First Affiliated Hospital of Soochow University

1. Study Identification

Unique Protocol Identification Number

NCT03275493

Brief Title

Humanized CD19 CAR-T Cells With CRS Suppression Technology for r/r CD19+ Acute Lymphoblastic Leukemia

Official Title

Humanized Chimeric Antigen Receptor T Cells Against CD19 With Cytokine Release Syndrome (CRS) Suppression Technology for Refractory/Relapsed CD19+ Acute Lymphoblastic Leukemia

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

July 1, 2017 (Actual)

Primary Completion Date

September 18, 2023 (Anticipated)

Study Completion Date

September 18, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

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

Collaborators

The First Affiliated Hospital of Soochow University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

This is a single center,randomized ,two-cohorts, open-label ,phase 1/2 study to evaluate the efficacy and safety of T cells expressing humanized CD19 chimeric antigen receptors treatment for relapsed/refractory CD19+ acute lymphoblastic leukemia patients.

Detailed Description

Relapsed/refractory CD19 + acute lymphoblastic leukemia patients were randomly enrolled in this study to compare the efficacy and safety between two cohorts: 1. Humanized CD19 CAR-T cells； 2. Humanized CD19 CAR-T cells with CRS suppression technology.

6. Conditions and Keywords

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

Acute Lymphoblastic Leukemia, CD19 Positive, Relapse, Refractory

Keywords

CD19+ ,CAR-T, CRS

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental: Cohort 1

Arm Type

Experimental

Arm Description

This cohort will determine the safety and efficacy of humanized CD19 CAR-T cells for CD19+ acute lymphoblastic leukemia

Arm Title

Experimental: Cohort 2

Arm Type

Experimental

Arm Description

This cohort will determine the safety and efficacy of humanized CD19 CAR-T cells with CRS suppression technology for CD19+ acute lymphoblastic leukemia.

Intervention Type

Biological

Intervention Name(s)

Humanized CD19 CAR-T cells

Intervention Description

Express a Second Generation 4-1BB:humanized CD19 CAR-T cells

Intervention Type

Biological

Intervention Name(s)

Humanized CD19 CAR-T cells with CRS suppression technology

Intervention Description

Express a Second Generation 4-1BB:humanized CD19 CAR-T cells with CRS suppression technology

Primary Outcome Measure Information:

Title

Incidence of severe CRS

Description

The safety of the humanized CD19 CAR-T cells treatment will be evaluated and the maximum tolerated dose will be determined

Time Frame

30 days after infusion of humanized CD19 CAR-T cells

Secondary Outcome Measure Information:

Title

Overall response of humanized CD19 CAR-T cells treatment who achieve morphology complete remission(CR) and MRD negativity.

Description

Time Frame

30 days after infusion of humanized CD19 CAR-T cells

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 6 to 65 Voluntary informed consent is given Expected survival ≥12 weeks Relapsed or refractory CD19+ acute leukemia, ineligible for allo-HSCT,or relapse after auto-HSCT Organ function: (1)Left ventricular ejection fractions≥ 0.6 by echocardiography (2)ALT ≤3 times of ULN, or bilirubin <2.0 mg/dl (3)Creatinine < 2 mg/dl and less than 2.5 × normal for age (4)Prothrombin time and activated partial thromboplastin time < 2 times of ULN (5)Arterial oxygen saturation> 92% Karnofsky score ≥ 60 ; No history of combined chemotherapy in the recent 1 month and no immunotherapy in the recent 3 months; Exclusion Criteria: Uncontrolled active infections Active hepatitis B or hepatitis C infection HIV infection History of myocardio infarction in the past 6 months, or history of severe arrhythmia Congenital immunodeficiency Pregnant or lactating women History or presence of clinically relevant CNS pathology such as epilepsy, generalized seizure disorder, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis Previous treatment with any gene therapy products

Central Contact Person:

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

Xiaowen Tang, PhD

Phone

8651267781525

tangxiaowen@suda.edu.cn

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

Lei Yu, PhD

Phone

8613818629089

ylyh188@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xiaowen Tang, PhD

Organizational Affiliation

The First Affiliated Hospital of Soochow University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The first affiliated hospital of soochow university

City

Suzhou

State/Province

Jiangsu

ZIP/Postal Code

200000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shengli Xue, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

36105799

Citation

Gong WJ, Qiu Y, Li MH, Chen LY, Li YY, Yu JQ, Kang LQ, Sun AN, Wu DP, Yu L, Xue SL. Investigation of the risk factors to predict cytokine release syndrome in relapsed or refractory B-cell acute lymphoblastic leukemia patients receiving IL-6 knocking down anti-CD19 chimeric antigen receptor T-cell therapy. Front Immunol. 2022 Aug 29;13:922212. doi: 10.3389/fimmu.2022.922212. eCollection 2022.

Results Reference

derived

PubMed Identifier

33235353

Citation

Hua J, Zhang J, Zhang X, Wu X, Zhou L, Bao X, Han Y, Miao M, Li C, Fu C, Chen S, Tang X, Wu D, Qiu H. Donor-derived anti-CD19 CAR T cells compared with donor lymphocyte infusion for recurrent B-ALL after allogeneic hematopoietic stem cell transplantation. Bone Marrow Transplant. 2021 May;56(5):1056-1064. doi: 10.1038/s41409-020-01140-6. Epub 2020 Nov 24.

Results Reference

derived

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Humanized CD19 CAR-T Cells With CRS Suppression Technology for r/r CD19+ Acute Lymphoblastic Leukemia

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