The FDA has placed a partial clinical hold on the phase II TELLOMAK trial, which is evaluating the safety and efficacy of lacutamab in patients with advanced T-cell lymphomas. The hold follows concerns from regulatory authorities about Good Manufacturing Practice deficiencies at manufacturing subcontractor sites.
Lacutamab is a first-in-class anti-KIR3DL2 humanized cytotoxicity-inducing antibody. Prior to the clinical hold, the TELLOMAK trial enrolled patients with previously treated Sézary syndrome, mycosis fungoides, or peripheral T-cell lymphoma. The regulatory action means that no new patients can enroll in the trial until a new batch of the drug is available, but patients who are currently enrolled in the trial can re-consent and continue treatment due to the high degree of unmet medical need.
The FDA did not cite any safety issues related to the trial medication in its notice, while Innate Pharma, the manufacturer of lacutamab, noted that internal and third-party analysis found no evidence that the integrity of the product was compromised. The company added that it is transferring manufacturing to another subcontractor and anticipates a new batch of the trial drug to be available in the second half of 2020.