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

Last updated: February 8, 2023
Sponsor: Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
Overall Status: Active - Recruiting

Phase

1/2

Condition

Leukemia

Treatment

N/A

Clinical Study ID

NCT05381662
UCT19-T19 v1.1
  • Ages 18-65
  • All Genders

Study 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 Criteria

Inclusion

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 timesof 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 therecent 3 months;

Exclusion

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, generalizedseizure 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

Study Design

Total Participants: 10
Study Start date:
August 02, 2018
Estimated Completion Date:
December 01, 2025

Study 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.

Connect with a study center

  • The first affiliated hospital of soochow university

    Suzhou, Jiangsu 215006
    China

    Active - Recruiting

  • The First Affiliated Hospital of Soochow University

    Suzhou,
    China

    Active - Recruiting

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