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

Launched by SHANGHAI UNICAR-THERAPY BIO-MEDICINE TECHNOLOGY CO.,LTD · May 18, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment for adults with acute lymphoblastic leukemia (ALL) who are in remission. The study aims to see how effective and safe a combination of specially modified T cells (which help the immune system fight cancer) and additional T cells that carry the same marker (CD19) is for treating patients. The trial is currently recruiting participants and is open to adults aged 18 to 65 who have a good chance of living for at least 12 more weeks and have certain healthy organ functions.

To participate, individuals must not have had recent chemotherapy or immunotherapy, and they should not have any uncontrolled infections or specific health issues that could complicate treatment. If eligible, participants will receive the new treatment and will be closely monitored for its effects. This study is important because it could lead to better options for people with ALL who are in remission, potentially improving their chances of staying healthy.

Gender

ALL

Eligibility criteria

• 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