Study of alloCART-19 Cell Therapy in Pediatric Patients With Relapsed/Refractory B-Cell Acute Lym… (NCT04173988) | Clinical Trial Compass
UnknownEarly Phase 1
Study of alloCART-19 Cell Therapy in Pediatric Patients With Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia
China6 participantsStarted 2020-01-09
Plain-language summary
The purpose of this study is to evaluate the safety and tolerability of CD19-Directed Allogeneic Chimeric Antigen Receptor T- cell (alloCART-19)therapy in pediatric patients with relapsed/refractory acute lymphoblastic leukemia（ALL）.
Who can participate
Age range1 Year – 18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Incomplete patients with conventional chemotherapy regimens, or primary refractory patients who failed to complete remission with 2 courses of standard chemotherapy regimen, or did not achieve complete remission after first-line or multi-line salvage chemotherapy
✓. Early recurrence after complete remission (\< 12 months) or late recurrence after complete remission (≥ 12 months) and chemotherapy was not completely relieved by the standardized two course induction regimens
✓. Recurrence after autologous or allogeneic hematopoietic stem cell transplantation
✓. Renal Function: serum creatinine ≤ 2 x ULN
✓. Liver Function: ALT and/or AST ≤ 10 x ULN (depending on age), bilirubin ≤ 5 x ULN
✕. Allogeneic cell therapy (including hematopoietic stem cell transplantation) within 6 weeks of alloCART-19 infusion
✕. Any live vaccine within 4 weeks of alloCART-19 infusion and/or plan to receive live vaccine after enrollment
✕. Immunosuppressants for GvHD treatment within 4 weeks of alloCART-19 infusion
✕. Systemic corticosteroid treatment at doses greater than 5 mg/day prednisone\*3 days (or equivalent corticosteroids) within 72 hours prior to alloCART-19 treatment
What they're measuring
1
Dose Limiting Toxicity
Timeframe: Day 28 after the first alloCART-19 infusion
✕. Before receiving alloCART-19 treatment, had received the following anti-neoplastic therapies: Tyrosine kinase inhibitors and hydroxyurea within 72 hours; Vincristine, 6-mercaptopurine, 6-thioguanine, methotrexate \< 25 mg/m2, cytosine arabinoside \< 100 mg/m2/day, or asparaginase (non-pegylated) within 1-week; Pegylated-asparaginase within 4 weeks; Central nervous system disease prophylaxis (e.g. intrathecal methotrexate) within 1 week; Investigational drug treatment within 4 weeks
✕. Had received the following anti-neoplastic radiotherapy before receiving alloCART-19 treatment: Radiotherapy for non-CNS sites within 2 weeks; Radiotherapy for the CNS site within 8 weeks
✕. Grade 2 to 4 acute or extensive chronic graft-versus-host disease (GVHD)
✕. Isolated extramedullary disease recurrence (e.g. central nervous system and testis)