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Patient fails organ-function thresholds for CAR-T cell therapy: any of LVEF <40%, CrCl <3...

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

IDRF-CAR-T-INELIGIBLE-ORGAN
TypeRed flag
Statusreviewed 2026-04-27 | pending_clinical_signoff
DiseasesNone declared
SourcesSRC-TRANSCEND-NHL-001-ABRAMSON-2020 SRC-ZUMA-1-NEELAPU-2017

Red Flag Origin

DefinitionPatient fails organ-function thresholds for CAR-T cell therapy: any of LVEF <40%, CrCl <30 mL/min, bilirubin >2× ULN (non-Gilbert / non-disease- related), AST/ALT >5× ULN, severe pulmonary disease (DLCO <40% or O2 requirement), or uncontrolled active infection. Triggers exclusion from CAR-T pathways and pivot to bispecific antibodies, ADC, or salvage chemotherapy.
Clinical directionhold
Categoryorgan-dysfunction

Trigger Logic

{
  "any_of": [
    {
      "comparator": "<",
      "finding": "lvef_percent",
      "threshold": 40
    },
    {
      "comparator": "<",
      "finding": "creatinine_clearance_ml_min",
      "threshold": 30
    },
    {
      "comparator": ">",
      "finding": "bilirubin_ratio_to_uln",
      "threshold": 2
    },
    {
      "comparator": ">",
      "finding": "ast_alt_ratio_to_uln",
      "threshold": 5
    },
    {
      "finding": "active_uncontrolled_infection",
      "value": true
    }
  ],
  "type": "composite_score"
}

Notes

Pivotal trial exclusions; real-world data (CIBMTR, French DESCAR-T) suggest some flexibility but at increased CRS/ICANS-mortality cost. Alternatives by disease: DLBCL/HGBL — bispecifics (epcoritamab, glofitamab), polatuzumab + bendamustine + rituximab (POLARIX salvage setting), tafasitamab + lenalidomide (L-MIND); MCL — pirtobrutinib, bendamustine-based regimens; multiple myeloma — talquetamab, teclistamab, elranatamab, selinexor combinations, belantamab. Direction `hold` for CAR-T pathway only; other systemic therapy remains feasible with attenuation per RF-ORGAN-* siblings.

Used By

Algorithms

Red flag