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

Phase 1

Recruiting

• Conditions: Acute Lymphoblastic Leukemia in Remission
• Interventions: Biological: CD19 CAR-T cells and CD19 positive feeder T cells

• Registration Number: NCT05381662
• Lead Sponsor: Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd

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.

Study Timeline

• Study Start: 2018-08-02
• Study First Submitted: 2018-08-05
• Study First Submitted QC: 2022-05-18
• Study First Posted: 2022-05-19
• Status Verified: 2022-12
• Last Update Submitted: 2023-02-08
• Last Update Posted: 2023-02-10
• Primary Completion: 2024-08-02
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 2	CD19 CAR-T cells and CD19 positive feeder T cells	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
Cohort 1	CD19 CAR-T cells and CD19 positive feeder T cells	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

Primary Outcome Measures

Name	Time	Method
Incidence of severe CRS	12 months	The safety of the CD19 CAR-T cells and CD19 positive feeder T cells treatment will be evaluated

Trial Locations

Locations (2)

The First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, China

The first affiliated hospital of soochow university; 🇨🇳 Suzhou, Jiangsu, China