OncoMatch/Clinical Trials/NCT06101381
CD19-directed CAR-T Cell Therapy for R/R Acute Leukemia and Lymphoma
Is NCT06101381 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies CART-19 for leukemia, acute lymphoblastic.
Treatment: CART-19 — The goal of this prospective, multicentric, single-arm, phase I/II clinical trial is to evaluate the safety and efficacy of a novel CD19-directed CAR-T cell locally produced in an academic institution in Brazil in patients with refractory or relapsed acute lymphoblastic leukemia or non-Hodgkin lymphoma. Participants will receive a single intravenous infusion of an autologous academic anti-CD19 CAR-T cell and will be followed for 5 years.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD19 positive expression (documented within 3 months of screening)
Relapsed or refractory CD19 positive B-ALL, with documentation of CD19 disease expression within 3 months of screening visit.
Allowed: MYC rearrangement
Diffuse large B-cell lymphoma/high-grade B-cell lymphoma with MYC and BCL-2 rearrangement
Allowed: BCL2 rearrangement
Diffuse large B-cell lymphoma/high-grade B-cell lymphoma with MYC and BCL-2 rearrangement
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic therapy (anti-CD20 monoclonal antibody, anthracycline)
Refractory or relapsed to two or more lines of systemic therapy, with at least one scheme containing an anti-CD20 monoclonal antibody and anthracycline
Cannot have received: CAR-T cell therapy
History of previous CAR-T therapy
Cannot have received: solid organ transplantation
History of previous solid organ transplantation
Lab requirements
Blood counts
ANC >500/uL; Platelets ≥ 50,000/uL; Hemoglobin >7.0 g/dl (regardless of transfusions for 14 days)
Kidney function
eGFR ≥ 40 mL/min/1.73 m2
Liver function
ALT and AST ≤ 2.5 × ULN (B-NHL); ALT and AST ≤ 5 × ULN (B-ALL); Total bilirubin ≤ 1.5 × ULN (B-NHL), ≤ 2 × ULN (B-ALL), except for patients with Gilbert syndrome
Adequate organ function: Renal function: eGFR ≥ 40 mL/min/1.73 m2; Hepatic function: ALT and AST ≤ 2.5 × ULN (B-NHL), ≤ 5 × ULN (B-ALL); Total bilirubin ≤ 1.5 × ULN (B-NHL), ≤ 2 × ULN (B-ALL), except for patients with Gilbert syndrome; Hematologic: ANC >500/uL; Platelets ≥ 50,000/uL; Hemoglobin >7.0 g/dl
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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