This is a Phase I/II Interventional, Open-label Treatment Study Designed to Evaluate the Safety and Efficacy of Anti CD 19/22 CAR- T Cells Immunotherapy for Adults With Relapsed or Refractory Acute Lymphoblastic Leukemia/Lymphoma.

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMinsk Scientific-Practical Center for Surgery, Transplantation and Hematology

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • CD19/22 CAR-T cells

Treatment groups

17 Participants
are divided into 1 treatment group