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

Acute Lymphoblastic Leukemia Clinical Trial

Official title:

Humanized Chimeric Antigen Receptor T Cells Against CD19 With Cytokine Release Syndrome (CRS) Suppression Technology for Refractory/Relapsed CD19+ Acute Lymphoblastic Leukemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03275493
• Other study ID #: UnicarTherapy201701
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: July 1, 2017
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2023
• Source: Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
• Contact: Xiaowen Tang, PhD
• Phone: 8651267781525
• Email: tangxiaowen[@]suda.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 humanized CD19 chimeric antigen receptors treatment for relapsed/refractory CD19+ acute lymphoblastic leukemia patients.

Description:

Relapsed/refractory CD19 + acute lymphoblastic leukemia patients were randomly enrolled in this study to compare the efficacy and safety between two cohorts: 1. Humanized CD19 CAR-T cells； 2. Humanized CD19 CAR-T cells with CRS suppression technology.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• CD19 Positive
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Refractory
• Relapse

Intervention

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

Locations

Country	Name	City	State
China	The first affiliated hospital of soochow university	Suzhou	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd	The First Affiliated Hospital of Soochow University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of severe CRS	The safety of the humanized CD19 CAR-T cells treatment will be evaluated and the maximum tolerated dose will be determined	30 days after infusion of humanized CD19 CAR-T cells
Secondary	Overall response of humanized CD19 CAR-T cells treatment who achieve morphology complete remission(CR) and MRD negativity.	The efficacy of the humanized 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 humanized CD19 CAR- T cells infusion	30 days after infusion of humanized CD19 CAR-T cells