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# Clinical Hold for Innate Lacutamab Trials
- URL: https://www.fdaweb.com/clinical-hold-for-innate-lacutamab-trials/
- Published: 2023-10-05T12:00:00.000Z
- Updated: 2026-09-14T19:01:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155489

FDA has placed a partial clinical hold on the Innate Pharma lacutamab IND, leading to a pause in patient enrollment in the company’s Phase 2 TELLOMAK and Phase 1b PTCL trials in cutaneous and peripheral T-cell lymphoma. A company [statement](https://www.innate-pharma.com/media/all-press-releases/innate-pharma-provides-update-lacutamab-clinical-program?ref=fdaweb.com) says the hold follows one fatal case of hemophagocytic lymphohistiocytosis.

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.