eligibility_summary
Include: ≥16, consent, WHO B‑cell NHL (LBCL/MCL), ECOG 0–2. A/B: after anti‑CD19 CAR T with measurable PR/SD/PD or relapse ≤9 mo, no post‑CAR‑T therapy. C/D: LBCL/MCL, NCCP‑approved for anti‑CD19 CAR T, adequate cardiac, O2 ≥92%. Exclude: active cancer, infection/immunosuppression, CNS disease, pregnancy, recent major surgery, high‑risk comorbidity, IMP trials. CAR‑T safety: no severe/persistent CRS/ICANS or unresolved ≥G3 organ toxicity, infections controlled.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Trial: NCT06045910 (Phase I/II, open-label). Intervention: ALETA-001, an IV, q2-week, protein biologic “CAR T-cell engager.” Mechanism: ALETA-001 binds the anti-CD19 CAR on previously infused CAR T cells and simultaneously binds antigens on malignant B cells, bridging them to form an immune synapse. This reactivates and expands residual CD19-CAR T cells, redirects them to tumor cells, and may overcome CD19-loss or suboptimal post–CAR T responses. Targets: - Effector cells: Anti-CD19 CAR T cells (activating CAR signaling pathways such as CD3ζ with 4-1BB/CD28 costimulation). - Tumor: B-cell malignancies (LBCL, MCL, follicular, etc.), via B-cell surface antigens. Purpose: Optimize dosing/timing and assess safety, PK, and antitumor activity post–CD19 CAR T therapy.