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

Phase 1

Recruiting

• Conditions: Refractory; Relapse; Acute Lymphoblastic Leukemia; CD19 Positive
• Interventions: Biological: CD19 CAR-T cells; Biological: CD19 CAR-T cells with CRS suppression technology

• Registration Number: NCT03275493
• 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 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. CD19 CAR-T cells； 2. CD19 CAR-T cells with CRS suppression technology.

Study Timeline

• Study Start: 2017-07-01
• Study First Submitted: 2017-09-05
• Study First Submitted QC: 2017-09-06
• Study First Posted: 2017-09-07
• Status Verified: 2023-11
• Last Update Submitted: 2024-05-24
• Last Update Posted: 2024-05-28
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental: Cohort 1	CD19 CAR-T cells	This cohort will determine the safety and efficacy of CD19 CAR-T cells for CD19+ acute lymphoblastic leukemia
Experimental: Cohort 2	CD19 CAR-T cells with CRS suppression technology	This cohort will determine the safety and efficacy of CD19 CAR-T cells with CRS suppression technology for CD19+ acute lymphoblastic leukemia.

Primary Outcome Measures

Name	Time	Method
Incidence of severe CRS	30 days after infusion of CD19 CAR-T cells	The safety of the CD19 CAR-T cells treatment will be evaluated and the maximum tolerated dose will be determined

Secondary Outcome Measures

Name	Time	Method
Overall response of CD19 CAR-T cells treatment who achieve morphology complete remission(CR) and MRD negativity.	30 days after infusion of CD19 CAR-T cells	The efficacy of the 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 CD19 CAR- T cells infusion

Trial Locations

Locations (1)

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