OncoMatch/Clinical Trials/NCT06447987
Humanized CD19-Specific CAR T Cells for the Treatment of Patients With Positive Relapsed or Refractory CD19 Positive B-Cell Acute Lymphoblastic Leukemia
Is NCT06447987 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem-enriched T-lymphocytes and Cetuximab for recurrent acute lymphoblastic leukemia.
Treatment: CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem-enriched T-lymphocytes · Cetuximab · Cyclophosphamide · Fludarabine — This phase Ib trial tests the safety, side effects, and effectiveness of humanized (hu)CD19-chimeric antigen receptor (CAR) T cell therapy in treating patients with CD19 positive B-cell acute lymphoblastic leukemia (ALL) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). CAR T-cell therapy is a treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein, such as CD19, on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the huCD19 positive CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Chemotherapy drugs, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. huCD19-CAR T cell therapy may be safe, tolerable and effective in treating patients with relapsed or refractory CD19 positive ALL.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: CD19 overexpression (positive)
Histologically confirmed CD19+ relapsed/refractory ALL
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received:
at least 2 prior lines of therapy
Cannot have received: CAR-T cell therapy
Exception: Participants who have previously received B-cell-activating factor receptor (BAFFR)-CAR T cells will be excluded from this study
Received prior CAR T therapy within 90 days of enrollment
Cannot have received: allogeneic stem cell transplant
Allogeneic stem cell transplant within 100 days at the time of enrollment
Lab requirements
Kidney function
Creatinine clearance of ≥ 50 mL/min per 24-hour urine test or the Cockcroft-Gault formula
Liver function
Total bilirubin ≤ 2.0 X upper limit of normal (ULN) (unless has Gilbert's disease or related to leukemia involving the liver); AST ≤ 2.5 x ULN (unless related to leukemia involving the liver); ALT ≤ 2.5 x ULN (unless related to leukemia involving the liver)
Cardiac function
Left ventricular ejection fraction (LVEF) ≥ 45%; Corrected QT interval (QTc) must be ≤ 480 msec
Total bilirubin ≤ 2.0 X upper limit of normal (ULN) (unless has Gilbert's disease or related to leukemia involving the liver) Aspartate aminotransferase (AST) ≤ 2.5 x ULN (unless related to leukemia involving the liver) Alanine aminotransferase (ALT) ≤ 2.5 x ULN (unless related to leukemia involving the liver) Creatinine clearance of ≥ 50 mL/min per 24-hour urine test or the Cockcroft-Gault formula Left ventricular ejection fraction (LVEF) ≥ 45% Corrected QT interval (QTc) must be ≤ 480 msec
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope Medical Center · Duarte, California
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