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Composite eligibility for CAR-T cell therapy: ECOG ≤2 AND adequate organ function (LVEF ≥...

Deterministic view of the source YAML entity. Clinical authority remains with the cited source IDs and reviewer sign-off state.

IDRF-CAR-T-ELIGIBLE
TypeRed flag
Statusreviewed 2026-04-27 | pending_clinical_signoff
DiseasesNone declared
SourcesSRC-ZUMA-1-NEELAPU-2017 SRC-ZUMA-7-LOCKE-2022

Red Flag Origin

DefinitionComposite eligibility for CAR-T cell therapy: ECOG ≤2 AND adequate organ function (LVEF ≥40%, CrCl ≥30 mL/min, bilirubin ≤2× ULN, AST/ALT ≤5× ULN, no severe pulmonary disease) AND no active uncontrolled CNS disease AND adequate bridging plan available AND no active uncontrolled infection. Used to gate referral to axi-cel, brexu-cel, liso-cel, tisa-cel, ide-cel, cilta-cel.
Clinical directionintensify
Categoryfitness-eligibility

Trigger Logic

{
  "all_of": [
    {
      "comparator": "<=",
      "finding": "ecog",
      "threshold": 2
    },
    {
      "comparator": ">=",
      "finding": "lvef_percent",
      "threshold": 40
    },
    {
      "comparator": ">=",
      "finding": "creatinine_clearance_ml_min",
      "threshold": 30
    },
    {
      "comparator": "<=",
      "finding": "bilirubin_ratio_to_uln",
      "threshold": 2
    },
    {
      "finding": "active_cns_disease",
      "value": false
    },
    {
      "finding": "active_uncontrolled_infection",
      "value": false
    }
  ],
  "type": "composite_score"
}

Notes

Composite gate harmonized across landmark CAR-T trials (ZUMA-1, TRANSCEND, JULIET, ZUMA-7, TRANSFORM, ZUMA-2, KarMMa, CARTITUDE-1). Real-world expansion of criteria (CIBMTR analysis): ECOG 2 acceptable with consultant judgment; LVEF 40-50% acceptable with cardiology input; bilirubin elevation from disease (Gilbert, hemolysis, cholestasis) vs primary hepatic dysfunction must be distinguished. Active CNS disease requires control (resection / IT / RT) before lymphodepletion; some centers offer CAR-T for primary CNS lymphoma with restricted criteria. Bridging plan is critical — manufacture takes 2-5 weeks; if bridging chemo gives PR/CR, lymphodepletion still scheduled. Ineligibility for one product (e.g., cilta-cel parkinsonism risk) does not preclude another (ide-cel) — re-evaluate per product.

Used By

Algorithms

Red flag