OncoMatch/Clinical Trials/NCT06227026
Pilot Study of Anti-CD19 Chimeric Antigen Receptor T Cells (CAR-T Cells) for the Treatment of Relapsed/Refractory CD19+ Malignancies
Is NCT06227026 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Anti-CD19 CAR-T cells for acute lymphoblastic leukemia.
Treatment: Anti-CD19 CAR-T cells — This is an open label, non-randomized, phase 1 study of anti-CD19 CAR-T cells against relapsed CD19 positive NHL, CLL and ALL based in a lymphodepletion regimen (fludarabine and cyclophosphamide) and using a CellReGen-based process for manufacturing CAR-T cells. This study will utilize a staggered enrollment design with a safety observation period.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Diffuse Large B-Cell Lymphoma
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD19 positive (positive)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: autologous or allogeneic stem cell transplant
Exception: allowed if >6 weeks before planned CAR-T cell infusion
Autologous or allogeneic stem cell transplant or CAR-T therapy within 6 weeks of planned CAR-T cell infusion.
Cannot have received: CAR-T cell therapy
Exception: allowed if >6 weeks before planned CAR-T cell infusion
Autologous or allogeneic stem cell transplant or CAR-T therapy within 6 weeks of planned CAR-T cell infusion.
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥ 500/mm3; Platelet count ≥ 10,000/mm3; Hemoglobin ≥ 8 g/dL
Kidney function
Serum Creatinine ≤ 2 x institutional upper limit of normal (ULN) or eGFR >30 ml/min/1.73m2
Liver function
Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN). AST(SGOT)/ALT(SGPT) ≤ 3 × institutional ULN
Cardiac function
No congestive heart failure NYHA Class III or IV, unstable angina, serious arrhythmias, stroke/TIA/MI/thromboembolic event within 3 months, QTcF > 500 ms, known congenital long QT, LVEF < 55%, uncontrolled hypertension ≥ 140/90
Adequate organ function as defined as: Hematologic: ANC ≥ 500/mm3, Platelet count ≥ 10,000/mm3, Hemoglobin ≥ 8 g/dL; Hepatic: Total Bilirubin ≤ 1.5x institutional ULN, AST(SGOT)/ALT(SGPT) ≤ 3 × institutional ULN; Renal: Serum Creatinine ≤ 2 x institutional ULN or eGFR >30 ml/min/1.73m2. Cardiovascular disorders: see exclusion criteria.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Huntsman Cancer Institute · Salt Lake City, Utah
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