ORR of 84.6%: China-developed CD7 CAR-T Therapy PA3-17 Nominated for Breakthrough Therapy Designation

On August 7, the CDE website showed that Bo Sheng Ji Medicine Science and Technology (Suzhou) Co., LTD developedCD7 CAR-T Therapy PA3-17 InjectionProposed for inclusion in the breakthrough therapy category, indicated for the treatment ofAdult Relapsed/Refractory T Lymphoblastic Leukemia/Lymphoma. In Phase I clinical trials,PA3-17 has shown promise in treating this type of patientAn objective response rate of up to 84.6%（ORR）。

Screenshot source: CDE official website

Unlike traditional therapies such as CD19-CAR-T and BCMA-CAR-T, the development and clinical application of CD7-CAR-T cells have faced numerous challenges. For example: both tumor T cells and normal T cells express CD7, leading to mutual killing among CAR-T cells during the conventional manufacturing process, making it difficult to obtain an effective product; residual tumor T cells in the CAR-T cell product can prevent its release; temporary reduction of T lymphocytes increases the risk of infection, and so on.

According to Bo Sheng Ji Medicine Science and Technology (Suzhou) Co., LTD, its development ofPA3-17 adopts two innovative technologies:1. Nanobody Design, this innovative design can significantly enhance the killing and infiltration capabilities of CAR-T cells against tumors, enabling them to attack tumor cells more precisely and effectively;Second, PEBL blocking technology, using a non-gene-editing approach, ingeniously prevents CAR-T cells from attacking each other, significantly enhancing the safety of the treatment.

At the 2025 EHA conference, Bo Sheng Ji Medicine Science and Technology (Suzhou) Co., LTD announced the PA3-17 injection for the treatment of relapsed/refractory T lymphoblastic leukemia/lymphoma.（R/R T-ALL/LBL）Long-term follow-up data from the Phase I clinical trial. Thirteen patients with advanced R/R T-ALL/LBL who had failed multiple lines of treatment were treated with PA3-17 injection, and the data showed:

• Objective response rate as high as 84.6%（11/13）, among which76.9% of patients achieved complete remission, with significant anti-tumor effects.

• Among patients who achieved complete remission at 3 months,50% sustained relief for more than 15 months, and none of them have undergone stem cell transplantation, bringing new hope for the long-term survival of patients.

• Controllable Safety: No ICANS of grade 3 or higher occurred during the treatment; the incidence of CRS of grade 3 or higher was only 23.1%, with no grade 4 CRS.

Insight database shows that no CD7-targeted drug has been approved globally. In the CD7 CAR-T field, there are currently 25 drugs in research that have entered clinical trials worldwide.(Only active status is counted), 20 of which are developed by domestic enterprises/institutions. The fastest progress in research is in Phase II, from companies such as Yakobiotech, Bo sheng ji medicine science and technology (suzhou) co., LTD, Beiheng Biotechnology, and Chentai Pharmaceuticals.

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