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

Acute Lymphoblastic Leukemia in Remission Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05381662
• Other study ID #: UCT19-T19 v1.1
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: August 2, 2018
• Est. completion date: December 1, 2025

Study information

• Verified date: December 2022
• Source: Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
• Contact: Depei Wu, Ph.D
• Phone: 86-13328008851
• Email: slxue[@]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 CD19 chimeric antigen receptors combined with CD19 positive feeder T cells treatment for CD19+ acute lymphoblastic leukemia patients in remission .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 1, 2025
• Est. primary completion date: August 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia in Remission
• Leukemia
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Biological:
• 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.

Locations

Country	Name	City	State
China	The first affiliated hospital of soochow university	Suzhou	Jiangsu
China	The first affiliated hospital of soochow university	Suzhou	Jiangsu
China	The First Affiliated Hospital of Soochow University	Suzhou

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 CD19 CAR-T cells and CD19 positive feeder T cells treatment will be evaluated	12 months