eligibility_summary
Eligibility: Adults 18–70 with R/R B‑ALL (CD19/CD22+, BM blasts ≥5%), ECOG 0–2, expected survival ≥3 months, adequate organ function, consent. Exclude: active CNS leukemia, other active/recent cancers, HBV/HCV/HIV/syphilis/CMV/EBV or uncontrolled infection, major CNS/heart/liver/kidney disease, serious comorbidities, allergy to study drugs, recent DLI/vaccine/surgery/HSCT/intense therapy, pregnancy/lactation/no contraception, poor cell yield, recent trial, unsafe per investigator.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT06659653 (recruiting). Intervention: PRG2302, an autologous, gene‑modified chimeric antigen receptor T‑cell (CAR‑T) therapy. Type: cellular immunotherapy. Mechanism of action: Patient T cells are engineered to express a dual‑target CAR recognizing CD19 and CD22 on B‑lineage cells. Upon antigen binding, CAR signaling (via CD3ζ plus costimulation) activates T‑cell cytotoxicity and cytokine release to kill malignant B lymphoblasts, dual targeting aims to reduce antigen‑escape relapse seen with single‑antigen CAR‑T. Dosing: single‑arm dose escalation (0.5, 1.0, 2.0×10^6 CAR‑T/kg). Targets: CD19+ and/or CD22+ B‑cell acute lymphoblastic leukemia cells, on‑target effects may deplete normal B cells. Population: adults with relapsed/refractory B‑ALL. Primary focus: safety and early efficacy.