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CD19 Chimeric Antigen Receptors and CD19 Positive Feeder T Cells as a Leukemia Consolidation Treatment

Primary Purpose

Acute Lymphoblastic Leukemia in Remission

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
CD19 CAR-T cells and CD19 positive feeder T cells
Sponsored by
Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Lymphoblastic Leukemia in Remission

Eligibility Criteria

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

Inclusion Criteria:

  1. Age 18 to 65
  2. Voluntary informed consent is given
  3. Expected survival ≥12 weeks
  4. Relieve CD19+ acute leukemia
  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

Sites / Locations

  • The first affiliated hospital of soochow universityRecruiting
  • The first affiliated hospital of soochow universityRecruiting
  • The First Affiliated Hospital of Soochow UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cohort 1

Cohort 2

Arm Description

This cohort will determine the safety and efficacy of CD19 CAR-T cells and CD19 positive feeder T cells for CD19+ acute lymphoblastic leukemia without Chemotherapy pretreatment

This cohort will determine the safety and efficacy of CD19 CAR-T cells and CD19 positive feeder T cells for CD19+ acute lymphoblastic leukemia with Chemotherapy pretreatment

Outcomes

Primary Outcome Measures

Incidence of severe CRS
The safety of the CD19 CAR-T cells and CD19 positive feeder T cells treatment will be evaluated

Secondary Outcome Measures

Full Information

First Posted
August 5, 2018
Last Updated
February 8, 2023
Sponsor
Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
Collaborators
The First Affiliated Hospital of Soochow University
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1. Study Identification

Unique Protocol Identification Number
NCT05381662
Brief Title
CD19 Chimeric Antigen Receptors and CD19 Positive Feeder T Cells as a Leukemia Consolidation Treatment
Official Title
CD19 Chimeric Antigen Receptors and CD19 Positive Feeder T Cells as a Leukemia Consolidation Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 2, 2018 (Actual)
Primary Completion Date
August 2, 2024 (Anticipated)
Study Completion Date
December 1, 2025 (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
No
Studies a U.S. FDA-regulated Device Product
No

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 CD19 chimeric antigen receptors combined with CD19 positive feeder T cells treatment for CD19+ acute lymphoblastic leukemia patients in remission .
Detailed Description
Patients were divided into two groups, group 1 and group 2, and each group was enrolled in 5 patients. Group 1 patients did not receive any pretreatment, and group 2 patients received pretreatment with cyclophosphamide and fludarabine prior to reinfusion. Then Patients were given Chimeric Antigen Receptor T-Cell( CAR-T) and CD19-positive T cells.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphoblastic Leukemia in Remission

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
This cohort will determine the safety and efficacy of CD19 CAR-T cells and CD19 positive feeder T cells for CD19+ acute lymphoblastic leukemia without Chemotherapy pretreatment
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
This cohort will determine the safety and efficacy of CD19 CAR-T cells and CD19 positive feeder T cells for CD19+ acute lymphoblastic leukemia with Chemotherapy pretreatment
Intervention Type
Biological
Intervention Name(s)
CD19 CAR-T cells and CD19 positive feeder T cells
Intervention Description
Detailed Description: Patients were divided into two groups, group 1 and group 2, and each group was enrolled in 5 patients. Group 1 patients did not receive any pretreatment, and group 2 patients received pretreatment with cyclophosphamide and fludarabine prior to reinfusion. Then Patients were given Chimeric Antigen Receptor T-Cell ( CAR-T) and CD19-positive T cells.
Primary Outcome Measure Information:
Title
Incidence of severe CRS
Description
The safety of the CD19 CAR-T cells and CD19 positive feeder T cells treatment will be evaluated
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 to 65 Voluntary informed consent is given Expected survival ≥12 weeks Relieve CD19+ acute leukemia 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
Depei Wu, Ph.D
Phone
86-13328008851
Email
slxue@suda.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Depei Wu, Ph.D
Organizational Affiliation
The First Affiliated Hospital of Soochow University
Official's Role
Study Chair
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
Facility Name
The first 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
Shengli Xue, MD
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Depei Wu, Ph.D
Phone
86-13328008851
Email
slxue@suda.edu.cn

12. IPD Sharing Statement

Learn more about this trial

CD19 Chimeric Antigen Receptors and CD19 Positive Feeder T Cells as a Leukemia Consolidation Treatment

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