Previously reported readouts from the Phase 1 INB-100 program have shown no severe graft-versus-host disease, persistence of allogeneic γδ T cells for up to one year post-infusion, and long-term leukemic remissions in multiple high-risk patients, including the earliest treated who are now beyond four to five years relapse-free relative to historical experience.
The core development today is operational: The Ohio State University has been added as a clinical site to the ongoing Phase 1 trial (NCT03533816) evaluating INB-100, a donor-derived allogeneic γδ T cell therapy administered after haploidentical stem cell transplant for leukemias. The sponsor is positioning the additional site to accelerate enrollment and complete the trial’s expansion cohort, with multiple centers reported to be actively screening and an updated data cut planned for next year.
Strategically, the site expansion reads as a scale and credibility play ahead of the next design decision. Haploidentical transplantation has grown as a practical option across diverse populations, but relapse and GVHD remain the operative risks that define post-transplant management. INB-100 targets that gap with an adoptive cellular approach intended to preserve graft-versus-leukemia while mitigating toxicity. Adding a high-volume transplant center broadens access to eligible patients, potentially smooths referral flow, and builds a trial network that can stress-test logistics around donor sourcing, cell processing, and synchronized infusion in the immediate post-transplant window. It also signals momentum to investors and regulators as the program moves from signal generation against historical benchmarks toward the level of evidence that would be required for a comparative study.
For sites, this is another example of academic transplant programs absorbing complex, protocol-driven cell therapy workflows layered onto standard post-transplant care. The operational lift spans donor-recipient chain-of-identity, apheresis and manufacturing scheduling, conditioning regimens, and release testing coordinated to transplant day timelines. CROs and vendors will need to harmonize apheresis logistics, cryo-chain management, and assay consistency across centers, while ensuring protocol adherence in a patient population with rapid clinical inflection points. Sponsors should expect ongoing scrutiny of manufacturing reproducibility across batches and sites, given the field’s sensitivity to product variability in allogeneic cell therapies. Regulators, meanwhile, will focus on durability, relapse kinetics, and GVHD incidence measured against contemporary haplo standards, with particular attention to how real-world comparators are selected and adjudicated.
The broader context is a crowded post-transplant intervention space that includes maintenance small molecules, antibody and NK-based approaches, and MRD-directed intensification. INB-100’s value proposition will hinge on whether the early safety signal and functional persistence translate to a measurable reduction in relapse without trading off on GVHD or infections in a prospective, controlled setting. Diversity of enrollment will matter as haploidentical access is often leveraged to reach underrepresented groups, and regulators have been explicit about performance across heterogeneous cohorts.
Next, watch the pace of expansion cohort enrollment across the enlarged site network, the maturation of one- and two-year relapse-free and overall survival landmarks, and confirmatory immune reconstitution data tied to clinical outcomes. The pivotal design question is whether the program advances into a randomized post-transplant study versus contemporary haplo standard of care; the feasibility of central manufacturing at scale, batch-release timelines, and inter-site product consistency will be gating factors. If the safety profile holds and the durability signal deepens, expedited pathways could come into view, but reliance on historical controls will not suffice for registration.
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.
