This is a Phase I/II Interventional, Open-label Treatment Study Designed to Evaluate the Safety a… (NCT07162571) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
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.
Belarus17 participantsStarted 2026-01-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Adequate organ system function including - Creatinine clearance ≥40 cc/min.
✓. Have no active GVHD (Grade 2-4)
✓. Adequate bone marrow (BM) function - Absolute neutrophil count ≥1.0 × 10\^9/L.
Exclusion criteria
✕. 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.
✕
What they're measuring
1
Phase I. Safety
Timeframe: 1 month post CAR-T cells infusion
2
Phase II. Overall response rate
Timeframe: 3 months post CAR-T cells infusion
Trial details
NCT IDNCT07162571
SponsorMinsk Scientific-Practical Center for Surgery, Transplantation and Hematology
. Active bacterial, viral or fungal infection requiring systemic treatment. Active or latent hepatitis B infection or hepatitis C infection. Testing positive for human immunodeficiency virus, human T cell lymphotropic virus (HTLV1 and 2) or syphilis.
✕. History of autoimmune disease resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 24 months.