OncoMatch/Clinical Trials/NCT07110090
Umbilical Cord Blood Megakaryocyte Injection (XJ-MK-002) for Cancer Therapy-Induced Thrombocytopenia (CTIT)
Is NCT07110090 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Umbilical Cord Blood Megakaryocyte for thrombocytopenia.
Treatment: Umbilical Cord Blood Megakaryocyte — 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.
Check if I qualifyExtracted eligibility criteria
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: anti-tumor treatment
thrombocytopenia due to anti-tumor treatments (e.g., chemotherapy, immunotherapy, targeted therapy, and radiotherapy)
Cannot have received: platelet transfusion or blood products containing platelet components
No transfusion of platelets or blood products containing platelet components within 72 hours prior to investigational product administration.
Cannot have received: thrombopoietin-stimulating drugs (recombinant human thrombopoietin (rhTPO), recombinant human interleukin-11 (rhIL-11), romiplostim, eltrombopag, hetrombopag, leucogen tablets, aminopeptidase tablets, caffeic acid tablets)
Use of thrombopoietin-stimulating drugs within 7 days prior to receiving the investigational product, including recombinant human thrombopoietin (rhTPO), recombinant human interleukin-11 (rhIL-11), romiplostim, eltrombopag, hetrombopag, leucogen tablets, aminopeptidase tablets, and caffeic acid tablets.
Cannot have received: anticoagulant drugs and/or antiplatelet therapy (vitamin K antagonists, low molecular weight heparin, factor Xa inhibitors (e.g., rivaroxaban), thrombin inhibitors, aspirin)
Exception: except for minimal heparin use for catheter locking
Use of anticoagulant drugs within 7 days before screening, including vitamin K antagonists, low molecular weight heparin (except for minimal heparin use for catheter locking), factor Xa inhibitors (e.g., rivaroxaban), thrombin inhibitors, and/or antiplatelet therapy (e.g., aspirin).
Cannot have received: investigational product with a similar mechanism of action
Exception: except for observational, non-interventional clinical trials, or the follow-up period of an interventional clinical trial
Use of any investigational product with a similar mechanism of action within 4 weeks prior to administration of the investigational product, or current participation in another clinical trial (except for observational, non-interventional clinical trials, or the follow-up period of an interventional clinical trial).
Lab requirements
Blood counts
Absolute neutrophils count <1.0×10⁹/L, hemoglobin <80g/L
Kidney function
creatinine clearance (Ccr) <50 mL/min, or serum creatinine (Cr) >1.5×ULN
Liver function
liver function (for non-liver cancer patients or those without liver metastasis): total bilirubin (TBIL) >2.5×ULN, alanine aminotransferase (ALT) >2.5×ULN, aspartate aminotransferase (AST) >2.5×ULN
Liver and kidney function abnormalities: liver function (for non-liver cancer patients or those without liver metastasis): total bilirubin (TBIL) >2.5×ULN, alanine aminotransferase (ALT) >2.5×ULN, aspartate aminotransferase (AST) >2.5×ULN; renal function: creatinine clearance (Ccr) <50 mL/min, or serum creatinine (Cr) >1.5×ULN. Complete blood count abnormalities: Absolute neutrophils count <1.0×10⁹/L, hemoglobin <80g/L.
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