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.
Single group
Umbilical Cord Blood Megakaryocyte Injection (XJ-MK-002)
Biological/Vaccinedosage form: Injection dosage: 10 mL/bag, 1×10⁷ cells/mL frequency: Each subject will be administered a single infusion of XJ-MK-001 at their respective enrolled dose level.
Incidence, severity, and relationship to XJ-MK-001 of adverse events within 28 days post-infusion of XJ-MK-002.
Incidence and severity of adverse events within 28 days.
a) The incidence, severity of adverse events and their correlation with XJ-MK-002 during study period. b) Change in platelet counts from baseline to D28 after XJ-MK-002 infusion.
Adverse events were evaluated according to CTCAE 5.0, platelet counts measured by blood routine test.
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