OncoMatch/Clinical Trials/NCT06287528
A Study of 19-28z/IL-18 in People With Acute Lymphoblastic Leukemia (ALL)
Is NCT06287528 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies 19-28z/IL-18 CAR T cells for philadelphia-negative all.
Treatment: 19-28z/IL-18 CAR T cells — Participants will have a sample of their white blood cells, called T cells, collected using a procedure called leukapheresis. The collected T cells will be sent to a laboratory to be changed (modified) to become 19-28z/IL-18, the CAR T-cell therapy that participants will receive during the study. Making the participants' study therapy will take about 2-4 weeks.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: CD19 positivity on leukemia blasts if prior anti-CD19 treatment
Documentation of CD19 positivity on leukemia blasts if prior anti-CD19 treatment
Performance status
ECOG/LANSKY 0–1
ECOG performance status 0-1 or Lansky performance status ≥ 60 for patients < 16 years old
Prior therapy
Must have received: multiagent systemic chemotherapy (induction and consolidation) — relapsed/refractory Ph-negative B-ALL
Refractory or relapsed disease to at least 1 prior multiagent systemic chemotherapy regimen that included both induction and consolidation therapy
Must have received: second- or third-generation tyrosine kinase inhibitor — relapsed/refractory Ph-positive B-ALL
persistent or progressive disease following at least 1 prior second- or third-generation tyrosine kinase inhibitor
Lab requirements
Kidney function
Serum creatinine <2.0mg/100mL
Liver function
ALT or AST ≤5x ULN and total bilirubin ≤2 (or ≤3 if history of Gilbert's syndrome or leukemic infiltration of the liver)
Cardiac function
SaO2 ≥92% on room air; Left ventricular ejection fraction (LVEF) ≥50% within 1 month of screening
Adequate organ function at time of screening, including: ALT or AST ≤5x ULN and total bilirubin ≤2 (or ≤3 if history of Gilbert's syndrome or leukemic infiltration of the liver); Serum creatinine <2.0mg/100mL; SaO2 ≥92% on room air; Left ventricular ejection fraction (LVEF) ≥50% within 1 month of screening
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) · Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) · Middletown, New Jersey
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) · Montvale, New Jersey
- Memorial Sloan Kettering Cancer Suffolk-Commack (Limited Protocol Activities) · Commack, New York
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) · Harrison, New York
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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