OncoMatch/Clinical Trials/NCT05054257
CART19 Cells Effects in Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma
Is NCT05054257 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Autologous CAR19 T lymphocytes for relapsed or refractory b-cell acute lymphoblastic leukemia.
Treatment: Autologous CAR19 T lymphocytes — Phase I Dose Escalation Study of CART19 Cells for Adult Patients With Relapsed / Refractory Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD19 expression (positive)
Prior therapy
Cannot have received: autologous or allogeneic hematopoietic cell transplantation
Autologous or allogeneic HCT in 3 months prior to IMP administration
Cannot have received: autologous or allogeneic hematopoietic cell transplantation
Autologous or allogeneic hematopoietic cell transplantation within 12 weeks (before apheresis)
Cannot have received: clofarabine (clofarabine)
Clofarabine within 8 weeks (before apheresis)
Cannot have received: fludarabine (fludarabine)
Fludarabine within 8 weeks (before apheresis)
Cannot have received: alemtuzumab (alemtuzumab)
Alemtuzumab within 8 weeks (before apheresis)
Cannot have received: donor lymphocyte infusion
Donor lymphocyte infusions within 4 weeks (before apheresis)
Cannot have received: pegylated asparaginase (pegylated asparaginase)
Pegylated asparaginase within 4 weeks (before apheresis)
Cannot have received: maintenance chemotherapy
Maintenance chemotherapy within 2 weeks (before apheresis)
Cannot have received: long-acting granulocyte colony stimulating factor
Long-acting Granulocyte Colony Stimulating Factor (G-CSF) within 2 weeks (before apheresis)
Cannot have received: vincristine (vincristine)
Vincristine within 2 weeks (before apheresis)
Cannot have received: intrathecal methotrexate (methotrexate)
Intrathecal methotrexate within 1 week (before apheresis)
Cannot have received: granulocyte colony stimulating factor
Granulocyte Colony Stimulating Factor (G-CSF) within 5 days (before apheresis)
Cannot have received: corticosteroids
Therapeutic dose of corticosteroids within 3 days (before apheresis)
Cannot have received: short-acting cytostatics
Short-acting cytostatics within 3 days (before apheresis)
Lab requirements
Kidney function
Acute kidney injury with serum creatinine > 180 µmol/L, oliguria or need for acute dialysis [excluded]
Liver function
Significant liver impairment: bilirubin > 50 µmol/L, AST or ALT > 4x normal upper limit [excluded]
Cardiac function
Heart failure with EF < 30% by echocardiography [excluded]
Significant liver impairment: bilirubin > 50 µmol/L, AST or ALT > 4x normal upper limit. Acute kidney injury with serum creatinine > 180 µmol/L, oliguria or need for acute dialysis. Heart failure with EF < 30% by echocardiography.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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