IN8bio has reported data from the ongoing Phase I clinical trial of its allogeneic gamma-delta T cell therapy candidate, INB-100, to treat leukaemia patients who are undergoing haploidentical hematopoietic stem cell transplant (HSCT).
So far, three high-risk acute myeloid leukaemia (AML) patients with complex cytogenetics have received the allogeneic derived, gamma-delta T cells that were extended and activated ex vivo.
The company noted that two of the subjects who received INB-100 have been in remission for 23.3 and 21 months and the third subject is continuing remission at 9.3 months following the cell therapy.
According to the exploratory clinical correlative findings, strong reconstitution of the immune system was observed in patients who received the treatment.
Positive trends in immune cell levels, including alpha-beta T cells, B cells and gamma-delta T cells were reported. This indicates that in subjects who received the cell therapy, the systemic immune system may demonstrate durable positive trends.
The safety and toxicity profile of INB-100 continues to be manageable without any therapy-associated Grade 3 or greater adverse events noted.
The single-institution, dose-escalation trial is underway at The University of Kansas Cancer Center (KUCC) in the US.
In the trial, INB-100 was given systemically to leukaemia patients after haploidentical HSCT.
Safety and tolerability are the primary endpoints of the trial while rates of graft versus host disease, overall survival and relapse rate are included as the secondary endpoints.
IN8bio chief scientific officer and co-founder Lawrence Lamb said: “We are encouraged by the patients’ responses to INB-100 treatment given this population’s high risk for recurrence.
“As we near the two-year mark in remission for our first and longest enrolled patient, we continue to monitor data from our ongoing clinical correlative studies, which are indicating a positive systemic immune response following the infusion of INB-100.”
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