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# Hold Lifted on Innate Lymphoma Trials
- URL: https://www.fdaweb.com/hold-lifted-on-innate-lymphoma-trials/
- Published: 2024-01-04T12:00:00.000Z
- Updated: 2026-09-14T14:19:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156077

FDA has lifted a partial clinical hold placed on Innate Pharma's Phase 2 TELLOMAK and Phase 1b PTCL trials of lacutamab in cutaneous and peripheral T-cell lymphoma. The hold was ordered 10/2023 following one fatal case of hemophagocytic lymphohistiocytosis ([see story](https://fdaweb.com/login.php?sa=v&aid=D5155489&cate=&stid=%241%245D5.or%2F.%24qMV14%2FcL1LBgVvPe5jWbu1&ref=fdaweb.com)).

The [company now says](https://www.innate-pharma.com/media/all-press-releases/innate-pharma-announces-us-fda-lifts-partial-clinical-hold-lacutamab-clinical-program?ref=fdaweb.com) the death was believed to be affected by Sézary Syndrome due to hemophagocytic lymphohistiocytosis, a rare hematologic disorder. “The FDA decision to lift the partial clinical hold is based on the FDA review of the fatal case which Innate, together with a steering committee of independent experts, determined to be related to aggressive disease progression and lacutamab unrelated,” it says.

Lacutamab is described as a first-in-class anti-KIR3DL2 humanized cytotoxicity-inducing antibody that is in clinical trials to treat cutaneous T-cell lymphoma and peripheral T-cell lymphoma.

FDA has granted the drug fast-track designation to treat patients with relapsed or refractory Sézary syndrome who have received at least two prior systemic therapies. The agency also granted it orphan drug status to treat cutaneous T-cell lymphoma.