(Limit: 5000 characters) The purpose of this phase I clinical study aims to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of SYS6055 Injection in participants with relapsed/refractory B-cell malignancies, and to provide evidence for recommending a dosage regimen for subsequent studies.
Age≥18 year, and voluntarily signed the Informed Consent Form (ICF);
Histologically confirmed B-cell malignancy with CD19 antigen-positive tumor cells;
Patients with relapsed/refractory B-cell malignancies who have failed standard therapy, including B-cell leukemia and B-cell lymphoma;
At least one measurable lesion according to the 2014 Lugano Response Criteria for Lymphoma;
History of other malignancy within 3 years or concurrent other active malignancy (participants with cured localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, carcinoma in situ of the breast, etc., may be enrolled);
Participants with bleeding diathesis, active bleeding, hemoptysis, or history of major bleeding within the previous 6 months; tumor invasion of major blood vessels shown by imaging (CT or MRI), or tumor judged by the investigator as highly likely to invade major blood vessels and cause fatal massive bleeding during the subsequent study period;
Participants with B-cell malignancies involving the central nervous system;
Received autologous hematopoietic stem cell transplantation within 3 months prior to the first dose;
Single group
SYS6055
DrugThe dose will be selected based on the dose cohort, with a single administration.
Dose-limiting toxicities (DLTs)
Occurrence of Adverse Events (AE) and Serious Adverse Events (SAE)
Recommended Phase 2 Dose (RP2D) or Maximum Tolerated Dose (MTD) of SYS6055
Objective Response Rate (ORR)
Time to Response（TTR）
Duration of Response (DoR)
Progression-free survival (PFS)
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