CD7 targeted “off-the-shelf” CAR-T demonstrates robust in vivo expansion and high efficacy in the treatment of patients with relapsed and refractory T-cell malignancies

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T-cell acute lymphoblastic leukemia (T-ALL) represents an area of high unmet medical needs. Once relapsed, patients have limited treatment options and usually a poor prognosis. T-ALL antigens such as CD7 is extensively expressed in normal T cells and natural killer (NK) cells, and extending the success of CAR-T therapy to T cell malignancies was challenged by CAR-T cell fratricide, the high production cost, long lagging time and potential product contaminations. GC027 is an “off-the-shelf” allogeneic CD7 targeted CAR-T therapeutic product for T cell malignancies. It demonstrated superior cell expansion and anti-leukemia efficacy in mouse xenograft model. In our previous study, we observed promising efficacy result in the first two r/r T-ALL patient treated with GC027. Deep and durable response in these two patients suggests the potential of a “off-the-shelf” allogeneic CAR-T product as a promising standalone therapy. In the expanded study, 11 out of 12 patients had extensive GC027 cell expansion, rapid eradication of T-lymphoblasts, and reached complete response within 1-month post infusion. At data cut-off of Nov. 30, 2022, 1 patient had progression free survival of > 3 years. With manageable toxicity profile, GC027 demonstrated superior clinical efficacy and durability in T cell malignancies.