IN8bio’s Phase 1 trial of INB-100, a gamma-delta T cell therapy for complex leukemias like AML, has shown promising results. All AML patients in the trial remain in complete remission with a median follow-up of 20.1 months, exceeding one-year progression-free survival and overall survival rates compared to historical control groups. The persistence of gamma-delta T cells beyond one year suggests the potential for durable remissions.
These findings hold significant potential for improving outcomes in high-risk AML patients, particularly those who undergo reduced-intensity conditioning and often face high relapse rates. The therapy’s apparent tolerability, without significant side effects like cytokine release syndrome or neurotoxicity, further enhances its potential to change the treatment landscape. This positive safety profile, coupled with durable remissions, could lead to wider adoption and improved quality of life for patients who often have limited effective options.
The trial data demonstrate a 100% remission rate in AML patients after almost two years post-transplant, significantly higher than the one-year progression-free survival (67.8% and 57.4%) and overall survival (74.7% and 66.7%) reported by CIBMTR and KUCC, respectively. Importantly, these positive results are observed in a patient population with a median age of 68, often with complex, high-risk disease and prior treatment failures, including CAR-T therapies. The absence of severe side effects like cytokine release syndrome and neurotoxicity, combined with manageable graft-versus-host disease, reinforces the therapy’s favorable safety profile.
IN8bio’s positive clinical data for INB-100 suggests a potential shift in the treatment paradigm for high-risk AML. The company’s ongoing efforts to expand the trial network and lay the groundwork for a potential registrational trial indicate a commitment to bringing this promising therapy to a broader patient population. Future updates on the trial’s progress and regulatory pathway will be critical for gauging the therapy’s ultimate potential to improve outcomes for patients with this challenging disease.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
