A Clinical Study Exploring the Safety, Efficacy and Cell Metabolic Kinetics of Universal Car-t Cell Injection in CD19 and / or CD20 Positive Relapsed / Refractory B-cell Acute Lymphoblastic Leukemia in Adolescents, Children and Adults

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age12-75
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology

About this trial

This study is a single arm, open label, dose exploring clinical trial to evaluate the safety, efficacy, cellular metabolic dynamics, and pharmacodynamics of ct1190b cells in relapsed / refractory B-cell acute lymphoblastic leukemia.

Eligibility criteria

Qualifiers

voluntarily participate in clinical research; I fully understand and know this study and sign the informed consent form; ;

aged 12-75 years (inclusive);

The patients who did not achieve complete remission by the standardized induction chemotherapy, or early relapse (<12 months) after complete remission, or late relapse (≥ 12 months) after complete remission, and did not achieve complete remission by the standardized one course induction chemotherapy (except for the patients with late relapse who did not have a better treatment or did not tolerate other treatments according to the investigator's assessment), relapsed after 2 or more CR or CRI;

For ph+all patients, in addition to receiving standard induction chemotherapy, they should also receive at least two kinds of TKI treatment without complete remission or relapse after complete remission (except those who cannot tolerate TKI treatment or have contraindications to TKI treatment, or those with T315I mutation do not need to receive TKI treatment);

Disqualifiers

pregnant or lactating women;

there is HIV, syphilis infection, active hepatitis B virus infection (HBV-DNA is higher than the detection limit), or active hepatitis C virus infection (both HCV antibody and HCV-RNA are positive);

there is currently any uncontrollable active infection, including but not limited to patients with active tuberculosis (judged by the investigator);

there is active systemic autoimmune disease;

Trial design

Treatments tested in this trial

  • CT1190B cell injection

Treatment groups

18 Participants
are divided into 1 treatment group