Relapsed/refractory DLBCL with confirmed CD20 expression on malignant B-cells, post ≥2 pr...

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

ID	`RF-DLBCL-CD20-POS-EPCORITAMAB-CANDIDATE`
Type	Red flag
Status	reviewed 2026-04-29
Diseases	`DIS-DLBCL-NOS`
Sources	`SRC-ESMO-DLBCL-2024` `SRC-NCCN-BCELL-2025`

Red Flag Origin

Definition	Relapsed/refractory DLBCL with confirmed CD20 expression on malignant B-cells, post ≥2 prior systemic therapies including one anti-CD20 antibody-containing regimen (R-CHOP), CAR-T-ineligible or post-CAR-T failure — candidate for epcoritamab (CD20xCD3 bispecific T-cell engager; subcutaneous step-up administration). Pivotal data EPCORE NHL-1 phase 1/2 (Thieblemont 2023 J Clin Oncol): ORR 63%, CR 39%, mPFS 4.4 mo, mDOR 12 mo in 3L+ R/R DLBCL. Off-the-shelf alternative to CAR-T for non-eligible / bridging / post-failure setting. Distinct from glofitamab (different schedule: fixed 12 cycles vs continuous; IV vs SC). CD20-loss escape post-prior-anti-CD20 is a documented mechanism — re-biopsy advisable for late-relapse cohorts.
Clinical direction	intensify
Category	high-risk-biology

Trigger Logic

{
  "all_of": [
    {
      "any_of": [
        {
          "finding": "cd20_status",
          "value": "positive"
        },
        {
          "finding": "cd20_ihc",
          "value": "positive"
        },
        {
          "finding": "cd20_expression",
          "value": "preserved"
        }
      ]
    },
    {
      "any_of": [
        {
          "comparator": ">=",
          "finding": "prior_lines_count",
          "threshold": 2
        },
        {
          "finding": "post_cart_failure",
          "value": true
        },
        {
          "finding": "primary_refractory",
          "value": true
        }
      ]
    },
    {
      "any_of": [
        {
          "finding": "cart_ineligible",
          "value": true
        },
        {
          "finding": "cart_ineligibility_reason"
        },
        {
          "red_flag": "RF-DLBCL-CART-INELIGIBLE-POST-2L"
        },
        {
          "red_flag": "RF-CAR-T-INELIGIBLE-AGE-COMORBID"
        },
        {
          "red_flag": "RF-CAR-T-INELIGIBLE-ORGAN"
        },
        {
          "finding": "post_cart_relapse",
          "value": true
        }
      ]
    }
  ],
  "type": "composite_score"
}

Notes

Pivotal trial Source SRC-EPCORE-NHL-1-THIEBLEMONT-2023 not yet ingested — flagged in commit body for follow-up source-stub chunk; efficacy figures cited inline reflect Thieblemont et al. J Clin Oncol 2023 41(12):2238-2247 (DOI 10.1200/JCO.22.01725). Step-up schedule: cycle 1 days 1/8/15 priming (0.16 mg → 0.8 mg → 48 mg) to mitigate CRS; full dose 48 mg SC weekly cycles 1-3, biweekly cycles 4-9, q4w cycle 10+. CRS ~50% any grade / 2.5% G3+ (mostly cycle 1); ICANS ~6% / <1% G3+. Infection G3+ ~15%; tocilizumab + dexamethasone for CRS. Sequencing post-CAR-T: epcoritamab retains activity (cohort 1B EPCORE NHL-1 ~54% ORR post-CAR-T). NOT to be used in CD20-negative escape variants — re-biopsy if late-relapse. STUB — requires clinical co-lead signoff.

Used By

Indications

IND-DLBCL-3L-EPCORITAMAB - IND-DLBCL-3L-EPCORITAMAB