This study is a single-center, open-label, single-arm, dose-escalation clinical trial to assess safety \& tolerability of XJ-MK-002 in CTIT patients. It plans to recruit subjects aged 18 to 75 years old with chemotherapy-induced thrombocytopenia (CTIT). The study is designed with three dose levels: low dose (1.0×108 viable cells per person), medium dose (3.0×108 viable cells per person), and high dose (6.0×108 viable cells per person). The first dose group (low dose) will enroll one subject for accelerated titration, while the other two dose groups will enroll at least three subjects each. Subjects successfully enrolled will receive only one cell therapy session. After the cell therapy, they will undergo a 28-day dose-limiting toxicity (DLT) observation period.
Subjects aged 18 to 75 years (inclusive) at the time of signing the informed consent, regardless of gender.
Histologically and/or cytologically confirmed diagnosis of a malignant tumor, with thrombocytopenia due to anti-tumor treatments (e.g., chemotherapy, immunotherapy, targeted therapy, and radiotherapy), 50×10⁹/L≤platelet count (PLT) is ≤100×10⁹/L, confirmed by blood tests (with reconfirmation on the day prior to infusion) and with no bleeding
No transfusion of platelets or blood products containing platelet components within 72 hours prior to investigational product administration.
Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
History of platelet transfusion refractoriness.
History of severe allergic reactions related to blood transfusion.
History of bleeding disorders or thrombocytopenia caused by conditions other than CTIT.
Splenomegaly or hypersplenism.