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 (Sep 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
Treatments studied
Other
Cancer type
Acute Lymphoblastic Leukemia
Diffuse Large B-Cell Lymphoma
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD19 expression (positive)
CD-19+ must be confirmed by immunohistochemistry or flow cytometry analysis.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: chemoimmunotherapy — first-line
Subjects who are relapsed or refractory to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy.
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
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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Huntsman Cancer Institute · Salt Lake City, Utah
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06227026 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received chemoimmunotherapy.
Does this trial require CD19?
Yes, CD19 expression is a required biomarker for enrollment.
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