The purpose of this study is to estimate the safety and the efficacy of anti-CD19/22 CAR- T cells immunotherapy for adults with relapsed or refractory acute lymphoblastic leukemia/lymphoma.
Male or female, aged ≥18 years.
Willing and able to give written, informed consent.
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1.
Relapsed or refractory lymphoblastic leukemia/lymphoma.
Females who are pregnant or lactating.
History or presence of clinically relevant CNS pathology such as epilepsy, paresis, aphasia, stroke within prior 3 months, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, uncontrolled mental illness, or psychosis.
Patients with active CNS involvement by malignancy. Patients with history of central nervous system (CNS) involvement with malignancy may be eligible if CNS disease has been effectively treated and provided treatment was at least 4 weeks prior to enrolment (at least 8 weeks prior to CAR-T infusion).
Clinically significant, uncontrolled heart disease or a recent (within 12 months) cardiac event.
Single group
CD19/22 CAR-T cells
Biological/VaccineFollowing preconditioning with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with doses from 50 x 10⁶ to 150 x 10⁶ CD19/CD22 CAR-T cells
Phase I. Safety
Number of Participants With Grade 3-5 Toxicities. Adverse events will be graded according to the CTCAE v5.0
Phase II. Overall response rate
Including complete response (CR) and partial response (PR) rates
Phase I. CAR-T proliferation
To explore the pharmacokinetics of CAR-T cells: duration of expansion of CAR-T cells by flow cytometry, peak of expansion of CAR-T cells
Phase II. Efficacy: Overall survival rates
Overall survival rates
Phase II. Progression-free survival rates
progression-free survival time
Phase II. Duration of response
duration of response
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: