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

NCT ID: NCT05381662

Last Updated: 2023-02-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-02
• Study Completion Date: 2025-12-01

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.

Conditions

Acute Lymphoblastic Leukemia in Remission

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1

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

Group Type: EXPERIMENTAL

CD19 CAR-T cells and CD19 positive feeder T cells

Intervention Type: BIOLOGICAL

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.

Cohort 2

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

Group Type: EXPERIMENTAL

CD19 CAR-T cells and CD19 positive feeder T cells

Intervention Type: BIOLOGICAL

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.

Interventions

CD19 CAR-T cells and CD19 positive feeder T cells

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Soochow University

OTHER

Sponsor Role: collaborator

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

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Depei Wu, Ph.D

Role: STUDY_CHAIR

The First Affiliated Hospital of Soochow University

Locations

The first affiliated hospital of soochow university

Suzhou, Jiangsu, China

Site Status: RECRUITING

The first affiliated hospital of soochow university

Suzhou, Jiangsu, China

Site Status: RECRUITING

The First Affiliated Hospital of Soochow University

Suzhou, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Depei Wu, Ph.D

Role: CONTACT

slxue@suda.edu.cn

86-13328008851

Facility Contacts

Shengli Xue, MD

Role: primary

Shengli Xue, MD

Role: primary

Depei Wu, Ph.D

Role: primary

slxue@suda.edu.cn

86-13328008851

Other Identifiers

UCT19-T19 v1.1

Identifier Type: -

Identifier Source: org_study_id