eligibility_summary
Eligibility: R/R B‑ALL per NCCN/WHO, prior CAR‑T with loss of activity ≤6 months and no relapse, age 1–39, no severe allergies, ECOG 0–2, life expectancy ≥60 days, consent (patient ≥8 or guardian). Exclude: bendamustine <9 mo, CNS HTN/lesions or CSF blasts >20/µL, major cardiac/respiratory disease, other cancers, DIC, renal dysfunction, sepsis/active infections (HBV/HCV/HIV/syphilis), uncontrolled diabetes, severe mental illness, PB blasts >30%, prior transplant, pregnancy/lactation.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: 1) CIK cell therapy (cell therapy, autologous/allogeneic cytokine‑induced killer cells, typically CD3+CD56+ NKT‑like effectors expanded ex vivo). Mechanism: MHC‑unrestricted cytotoxicity against leukemia via NKG2D recognition of stress ligands (e.g., MICA/B/ULBPs), perforin/granzyme and Fas/FasL killing, plus cytokine production, intended to restore/support function and persistence of previously infused CAR‑T cells and mitigate early CAR‑T exhaustion. 2) mRNA‑CIK cells (cell therapy, CIK cells transiently modified by mRNA to enhance activity, experimental arm per protocol summary). Comparator: peripheral blood lymphocytes (autologous/allogeneic) as control cells. Targets: B‑ALL blasts (B‑lineage malignant cells), tumor stress‑ligand pathways engaging NKG2D, and dysfunctional CAR‑T cells (early T‑cell exhaustion/dysfunction pathways and persistence).