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

• Sponsor: Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05381662
• Collaborator: The First Affiliated Hospital of Soochow University (Other)
• Enrollment: 10
• Locations: 3
• Arms: 2
• Anticipated Duration (Months): 76
• Patients Per Site: 3.3
• Patients Per Site Per Month: 0

Study Details

Study Description

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 .

Condition or Disease	Intervention/Treatment	Phase
Acute Lymphoblastic Leukemia in Remission	Biological: CD19 CAR-T cells and CD19 positive feeder T cells	Phase 1/Phase 2

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: CD19 Chimeric Antigen Receptors and CD19 Positive Feeder T Cells as a Leukemia Consolidation Treatment
• Actual Study Start Date: Aug 2, 2018
• Anticipated Primary Completion Date: Aug 2, 2023
• Anticipated Study Completion Date: Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1 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	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.
Experimental: Cohort 2 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	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.

Outcome Measures

Primary Outcome Measures

1. Incidence of severe CRS [12 months]

   The safety of the CD19 CAR-T cells and CD19 positive feeder T cells treatment will be evaluated

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The first affiliated hospital of soochow university	Suzhou	Jiangsu	China	200000
2	The first affiliated hospital of soochow university	Suzhou	Jiangsu	China	215006
3	The First Affiliated Hospital of Soochow University	Suzhou		China

Sponsors and Collaborators

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

Investigators

• Study Chair: Depei Wu, Ph.D, The First Affiliated Hospital of Soochow University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
• ClinicalTrials.gov Identifier: NCT05381662
• Other Study ID Numbers: UCT19-T19 v1.1
• First Posted: May 19, 2022
• Last Update Posted: May 19, 2022
• Last Verified: Aug 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Study Results

No Results Posted as of May 19, 2022