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

Conditions

Acute Lymphoblastic Leukemia, CD19 Positive, Refractory, Relapse

Keywords

CD19+ ,CAR-T, CRS

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.

Ying Tang, Mengyun LI, Qingya Cui, Sining Liu, Zijian Li et al. (10 authors)

Journal of Translational Medicine2026-03-30

10.1186/s12967-026-07974-w

CAR-T cell therapy followed by allogenic hematopoietic stem cell transplantation yielded comparable outcome between Ph like ALL and other high-risk ALL.

Dai HP, Kong DQ, Shen HJ, Cui W, Wang Q, Li Z, Yin J, Kang LQ, Yu L, Wu DP, Tang XW.

2023-02-156 citations

10.1186/s40364-023-00451-2

Anti CD19 CART Therapy Following Allogenic Hematopoietic Stem Cell Transplantation Improved the Survival of Patients with <i> <i>BCR::ABL1</i> </i>-like Acute Lymphoblastic Leukemia

Haiping Dai, Wei Cui, Hongjie Shen, Qian Wang, Jia Yin et al. (8 authors)

Blood2022-11-15

10.1182/blood-2022-166687

Investigation of the risk factors to predict cytokine release syndrome in relapsed or refractory B-cell acute lymphoblastic leukemia patients receiving IL-6 knocking down anti-CD19 chimeric antigen receptor T-cell therapy

Wenjie Gong, Yan Qiu, Minghao Li, Liyun Chen, Yanyan Li et al. (11 authors)

Frontiers in Immunology2022-08-2917 citations

10.3389/fimmu.2022.922212

Interventions

BIOLOGICALCD19 CAR-T cells

Express a Second Generation 4-1BB: CD19 CAR-T cells

BIOLOGICALCD19 CAR-T cells with CRS suppression technology

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

China

Contacts

Primary ContactXiaowen Tang, PhD

tangxiaowen@suda.edu.cn8651267781525

Backup ContactLei Yu, PhD

ylyh188@163.com8613818629089

Outcome results

None listed