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    Home > Active Ingredient News > Blood System > Industry heavyweight: Boshengji publishes long-term follow-up data of autologous CD7-CAR-T therapy in the treatment of r/r T-ALL/LBL

    Industry heavyweight: Boshengji publishes long-term follow-up data of autologous CD7-CAR-T therapy in the treatment of r/r T-ALL/LBL

    • Last Update: 2022-06-05
    • Source: Internet
    • Author: User
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    April 26, 2022/eMedClub News/--Recently, the team of Professor Zhang Mingming from the First Affiliated Hospital of Zhengzhou University and the R&D team of Boshengji Medical Technology (Suzhou) Co.
    , Ltd.
    A breakthrough result of CD7-CAR-T (PA3-17 injection) prepared by non-gene editing method in the treatment of relapsed and refractory T-ALL/T-LBL was jointly published in Cancer Research


    Different from previously published allogeneic CD7-CAR-T or donor-derived CD7-CAR-T treatment strategies, PA3-17 injection is an autologous CAR-T monotherapy targeting CD7

     In this study, the long-term follow-up of 8 patients was presented

    The results showed that 87.
    5% of the patients had more than 4 previous lines of treatment, and they all received a single infusion of PA3-17 injection after enrollment (only 1 patient received two reinfusions), and the infusion doses were the following three One of the dose levels: 1×106 CAR-T cells/kg, 1.
    5×106 CAR-T cells/kg, or 2×106 CAR-T cells/kg


    Among the 8 patients who received PA3-17 injection infusion, 6 patients (75.
    0%) achieved remission on day 30, and the remission rate increased to 87.
    5% (7/8) at 3 months; of these, 1 patient Maintained CR status for more than 12 months; the remaining patients maintained CR status for at least 3 months; in addition, for patients with T-lymphoblastic lymphoma involving the bone marrow (T-ALL/LBL), patients received PA3-17 injection After treatment, after the lymphoma was confirmed by PET-CT or CT scan, all lymphoma lesions (involving neck, axilla, peritoneum and other parts) reached CR status; bone marrow was detected by bone marrow smear and multicolor flow cytometry.
    All achieved CR and MRD- status


     ▲ Evaluation of imaging efficacy after infusion of PA3-17 injection in eLifer/r T-ALL/LBL patients (Image source: Reference 1) CAR-T cell expansion and persistence in vivo are key indicators of CAR-T efficacy.
    From the long-term follow-up data of the patients, CAR-T cells were effectively expanded in 8 patients.
    After about 12 days of reinfusion, the expansion of CAR-T cells in the body reached a peak, and the median copy peak was 857.
    2 cells.
    /µL, the presence of CAR-T cells could still be detected in patients even 270 days after reinfusion, confirming the good persistence of PA3-17 injection in vivo


     ▲ PK and PD analysis of PA3-17 injection in r/r T-ALL/LBL patients after infusion (image source reference 1) All 8 patients tolerated a single infusion of PA3-17 injection well, and No neurotoxic events (ICANS) were observed

    Although all 8 patients developed cytokine release syndrome (CRS) of varying degrees, the majority of patients (7 patients, 87.
    5%) had grade 1 or 2 CRS


    In addition, in this study, it can be seen from the long-term follow-up data of the patients that although the normal T cells of the patients will be cleared for a short time after the CAR-T cells are reinfused, the T cells of the patients will recover quickly.
    The reinfused autologous CD7-CAR-T cells proliferated in the patients, and on the other hand, the CD7-negative T cells in the patients would proliferate compensatively, and eventually all patients did not have obvious T cell deficiency


      ▲The patient's T cells recovered after infusion of PA3-17 injection (Image source: Document 1) Summary: r/r T-ALL/T-LBL is a highly aggressive hematological malignancy that is difficult to relapse The prognosis of patients treated with treatment is worse, the treatment options are very limited, and the 5-year survival rate is less than 10%

    The results of the long-term follow-up data of the PA3-17 injection-related study are gratifying, indicating that the product candidate is expected to become a potential CAR-T cell monotherapy

    It is believed that in the future, other indications other than T-ALL/LBL can be further expanded to meet more unmet clinical needs and benefit more patients

    About T-ALL/LBLT Lymphoblastic leukemia (T-ALL, T cell acute lymphoblastic leukemia) is a highly aggressive blood tumor

    Characterized by massive immature lymphoblastoid invasion of the bone marrow, standard treatments for T-ALL include radiation/chemotherapy and stem cell transplantation

    Standard chemotherapy regimens have only a 30%-40% response rate, and the median overall survival of responding patients is 6 months

    Among them, ETP-ALL has more extramedullary infiltration and retains the characteristics of more stem cells, resulting in a worse prognosis of its treatment; due to shared surface antigens and potential malignant cell contamination, CAR-T cells targeting T-ALL Therapeutic development is lagging behind

    In addition, since the FDA approved nelarabine in 2005 (commercialized by GlaxoSmithKline), no other new therapy for T-ALL has been approved, and in 2019 EHA (European Hematology Association) announced about nelarabine treatment The clinical phase IV data of T-ALL/T-LBL showed that the five-year survival rate of patients was only 18%, and the median survival time was 8 months

    About PA3-17 Injection The PA3-17 injection successfully developed by Boshengji adopts a non-gene editing strategy and has shown excellent pharmacokinetic and pharmacodynamic data in the previous study, with significant curative effect and high safety

    Moreover, due to the successful development of a highly optimized fully automatic preparation process, the cost is significantly reduced, and it is expected to become an innovative drug affordable for ordinary patients

    Currently, Boshengji is conducting a multi-center, investigator-initiated Phase I clinical trial in China to evaluate the safety and efficacy of PA3-17 injection in the treatment of relapsed and refractory T-ALL/LBL patients.
    This is also the world's first autologous CAR-T registration clinical trial based on CD7 target


    On April 19, 2022, the first patient of the Phase I clinical trial of PA3-17 injection was successfully reinfused in the First Affiliated Hospital of Zhengzhou University

    About Boshengji to become a leader in innovative cell drug research and development is Boshengji's vision, and it is Boshengji's mission to focus on unmet clinical needs and develop innovative drugs that patients really need

    Boshengji is a national high-tech enterprise with breakthrough tumor cell immunotherapy technology and cell drug product research and development as its main development goals

    The company focuses on the development of breakthrough First-in-class and Best-in-class CAR-T cell drugs with international leading level to benefit tumor patients

    References: 1.
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