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

Sponsor
Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03275493
Collaborator
The First Affiliated Hospital of Soochow University (Other)
40
Enrollment
1
Location
2
Arms
86.6
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Humanized CD19 CAR-T cells
  • Biological: Humanized CD19 CAR-T cells with CRS suppression technology
 Phase 1/Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Humanized Chimeric Antigen Receptor T Cells Against CD19 With Cytokine Release Syndrome (CRS) Suppression Technology for Refractory/Relapsed CD19+ Acute Lymphoblastic Leukemia
Actual Study Start Date :
Jul 1, 2017
Anticipated Primary Completion Date :
Sep 18, 2023
Anticipated Study Completion Date :
Sep 18, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental: Cohort 1

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

Biological: Humanized CD19 CAR-T cells
Express a Second Generation 4-1BB:humanized CD19 CAR-T cells
Experimental: Experimental: Cohort 2

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

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

Outcome Measures

Primary Outcome Measures

  1. Incidence of severe CRS [30 days after infusion of humanized CD19 CAR-T cells]

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

Secondary Outcome Measures

  1. Overall response of humanized CD19 CAR-T cells treatment who achieve morphology complete remission(CR) and MRD negativity. [30 days after infusion of humanized CD19 CAR-T cells]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Age 6 to 65

  2. Voluntary informed consent is given

  3. Expected survival ≥12 weeks

  4. Relapsed or refractory CD19+ acute leukemia, ineligible for allo-HSCT,or relapse after auto-HSCT

  5. 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%

  6. Karnofsky score ≥ 60 ;

  7. No history of combined chemotherapy in the recent 1 month and no immunotherapy in the recent 3 months;

Exclusion Criteria:

  1. Uncontrolled active infections

  2. Active hepatitis B or hepatitis C infection

  3. HIV infection

  4. History of myocardio infarction in the past 6 months, or history of severe arrhythmia

  5. Congenital immunodeficiency

  6. Pregnant or lactating women

  7. 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

  8. Previous treatment with any gene therapy products

Contacts and Locations

Locations

Site City State Country Postal Code
1 The first affiliated hospital of soochow university Suzhou Jiangsu China 200000

Sponsors and Collaborators

  • Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
  • The First Affiliated Hospital of Soochow University

Investigators

  • Principal Investigator: Xiaowen Tang, PhD, The First Affiliated Hospital of Soochow University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
ClinicalTrials.gov Identifier:
NCT03275493
Other Study ID Numbers:
  • UnicarTherapy201701
First Posted:
Sep 7, 2017
Last Update Posted:
May 19, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
CD19+ ,CAR-T, CRS
Additional relevant MeSH terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid

Study Results

No Results Posted as of May 19, 2022