The purpose of this study is to assess the safety, tolerability, and preliminary efficacy of SYNCAR-100 in patients with CD19-positive relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL). Participants who have signed the informed consent form will undergo screening against the inclusion and exclusion criteria. Eligible participants will receive study drug administration once weekly for a total of four doses, followed by a 1-year safety and efficacy follow-up observation period. After the completion of the study, long-term follow-up may be required for participants to monitor their health and survival status until 15 years post-treatment, or until the occurrence of patient death, loss to follow-up, or withdrawal of consent.
1.Aged 18 to 75 years (inclusive), of any gender.
2.Karnofsky Performance Status score ≥ 70.
3.Estimated life expectancy ≥ 12 weeks.
4.Positive CD19 expression on tumor cells confirmed by flow cytometry in bone marrow or peripheral blood.
1.Isolated extramedullary leukemia or isolated extramedullary relapse.
2.Central nervous system (CNS) involvement of leukemia at CNS2 stage.
3.A history of other malignant tumors, except for the following: cured non-melanoma skin cancer, carcinoma in situ of the uterine cervix, localized prostate cancer, superficial bladder cancer, ductal carcinoma in situ, or other malignant tumors with disease-free survival for more than 5 years.
4.Positive test results for any of the following infectious diseases: HIV; HCV; HBsAg; positive HBcAb with concurrent positive HBV DNA copy number; TPPA.
Single group
SYNCAR-100 Injection
DrugSubjects will receive intravenous injections once weekly for a total of 4 injections.
Adverse events（AE）
Evaluated through laboratory investigations, 12-lead electrocardiography, and vital signs.
Overall Response Rate（ORR）
Assessed according to the remission criteria for acute lymphoblastic leukemia (ALL)
Minimal Residual Disease（MRD）
Assessed according to the remission criteria for acute lymphoblastic leukemia (ALL)
Duration of Response（DOR）
Assessed according to the remission criteria for acute lymphoblastic leukemia (ALL)
Progression-Free Survival（PFS）
Assessed according to the remission criteria for acute lymphoblastic leukemia (ALL)
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Zhejiang University
Lead sponsor
Bisheng (Beijing) Biotechnology Co., Ltd.
Collaborator
