OncoMatch/Clinical Trials/NCT05038696
ALaCART-B: Acute Leukemia and Chimeric Antigen Receptor-T Cell Therapy for B-lymphoblastic Leukemia.
Is NCT05038696 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies CAR T-cell therapy for lymphoblastic leukemia, acute, childhood.
Treatment: CAR T-cell therapy — The objective of this study is to assess the safety and efficacy of a immunophenotype-adapted approach using CAR T-cells in patients with high-risk, refractory or relapsed B-lineage acute lymphoblastic leukemia (B-ALL).
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: BCR BCR-ABL1
BCR-ABL1
Required: ABL1 BCR-ABL1-like
BCR-ABL1-like
Required: ABL1 ABL1-r
ABL1-r
Required: PDGFRB PDGFRB-r
PDGFRB-r
Required: TCF3 TCF3-HLF
TCF3-HLF
Required: KMT2A (MLL) MLL-r
MLL-r
Required: TP53 pathogenic mutation
p53 pathogenic mutation as defined by RNA Seq or other molecular methods
Required: CD19 expression >99.9% (>99.9%)
Patients with > 99.9% of CD19 expression on blast cells will be eligible for anti-CD19 CAR T-cell infusion.
Required: CD19 expression <99.9% (<99.9%)
Patients with partial or absent CD19 expression (< 99.9%) on blast cells will be eligible to receive combinations of other CAR T-cells depending on the pattern of antigen expression.
Prior therapy
Cannot have received: car-t cell therapy
Lab requirements
Kidney function
normal age-adjusted egfr creatinine clearance within 3 months of screening
Liver function
alanine aminotransferase ≤ 5 times the upper limit of normal for age
Cardiac function
left ventricular systolic function ≥ 28% confirmed by echocardiogram, or left ventricular ejection fraction ≥ 45% confirmed by echocardiogram within 3 months of screening
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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