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 (Jun 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
Treatments studied
Other
Cancer type
Acute Lymphoblastic Leukemia
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD19 expression (positive)
Demographics
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.
Frequently asked questions
Is NCT05054257 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior autologous or allogeneic hematopoietic cell transplantation, autologous or allogeneic hematopoietic cell transplantation, clofarabine disqualifies patients from enrollment.
Does this trial require CD19?
Yes, CD19 expression is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 80 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify