Phase I Study of pCAR-19B in the Treatment of CD19-positive Relapsed/Refractory B-ALL in Children… (NCT04888468) | Clinical Trial Compass
CompletedPhase 1
Phase I Study of pCAR-19B in the Treatment of CD19-positive Relapsed/Refractory B-ALL in Children and Adolescents
China9 participantsStarted 2019-11-05
Plain-language summary
This is a phase I clinical study to evaluate the safety and tolerability of pCAR-19B in patients with relapsed or refractory B-ALL, and to obtain the maximum tolerated dose of pCAR-19B and phase II Recommended dose.
Who can participate
Age range3 Years – 21 Years
SexALL
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Inclusion criteria
✓. Diagnosed with B-ALL，and meet one of the following conditions:
✓. First-line or multiple-line salvage chemotherapy did not achieve complete remission；
✓. Early relapse after complete remission (\<12 months), or late relapse after complete remission (≥12 months) and complete remission has not been achieved after 1 course of treatment；
✓. Relapse after autologous or allogeneic hematopoietic stem cell transplantation;
✓. Ph+ALL patients should also receive at least two TKI treatments；
✓. For allogeneic hematopoietic stem cell transplant subjects, the following conditions must be met：
✓. Allo-HSCT takes ≥6 months before pCAR-19B infusion；
✓. No GVHD of grade 2 or above occurred within 2 weeks before PBMC collection;
Exclusion criteria
✕. With central nervous system disease at the time of screening;
✕. Have received CAR-T therapy or other genetically modified cell therapy;
✕. Participated in other clinical studies within 1 month before screening;
✕. Have received the following anti-tumor treatments before screening: received chemotherapy, targeted therapy or other experimental drug treatments within 14 days or at least 5 half-lives (whichever is shorter);
What they're measuring
1
Incidence of Adverse events after pCAR-19B infusion [Safety and Tolerability]
Timeframe: 28 days
2
Obtain the maximum tolerated dose of pCAR-19B cells[Safety and Tolerability]