eligibility_summary
Inclusion: 18–85, WHO-defined hematologic malignancy with an FDA-approved CAR T option, relapsed/refractory, ≥2 weeks or 5 half-lives since last therapy, toxicities ≤G1, infections resolved, ECOG 0–2, adequate hematologic/hepatic/cardiac function, WOCBP pregnancy test, consent and specimen compliance. Exclusion: auto/allo transplant <8 wks, uncontrolled infection, recent significant cardiac/CNS disease, ≥5 mg/d steroids/immunosuppression (10-day washouts), live vaccine <6 wks, severe hypersensitivity, pregnant/breastfeeding, no contraception, likely noncompliance, myeloid clonal hematopoiesis.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions and mechanisms: • CAR T-cell therapy (biologic, autologous genetically engineered T cells). Uses any FDA-approved product matched to disease: typically anti-CD19 for DLBCL/MCL/ALL and anti-BCMA for multiple myeloma. Mechanism: CAR recognition of target antigen activates T cells (CD3ζ with 4‑1BB/CD28 costimulation), leading to cytokine release and cytotoxic killing of malignant cells. • Autologous hematopoietic stem cells (aHSCs, biologic, CD34+ stem cell infusion) given Day 10 after CAR T (Day 0). Mechanism: hematopoietic rescue/reconstitution to mitigate CAR T–associated prolonged cytopenias and support durability of response. Cells/pathways targeted: CD19+ B cells and BCMA+ plasma cells, T-cell effector and cytokine pathways implicated in CRS/ICANS.