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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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 .

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Age 18 to 65

• Voluntary informed consent is given

• Expected survival ≥12 weeks

• Relieve CD19+ acute leukemia

• 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%

• Karnofsky score ≥ 60 ;

• No history of combined chemotherapy in the recent 1 month and no immunotherapy in the recent 3 months;

Locations
Other Locations
China
The first affiliated hospital of soochow university
RECRUITING
Suzhou
The first affiliated hospital of soochow university
RECRUITING
Suzhou
The First Affiliated Hospital of Soochow University
RECRUITING
Suzhou
Contact Information
Primary
Depei Wu, Ph.D
slxue@suda.edu.cn
86-13328008851
Time Frame
Start Date: 2018-08-02
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 10
Treatments
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
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
Sponsors
Leads: Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
Collaborators: The First Affiliated Hospital of Soochow University

This content was sourced from clinicaltrials.gov

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