NCT07110090

Umbilical Cord Blood Megakaryocyte Injection (XJ-MK-002) for Cancer Therapy-Induced Thrombocytopenia (CTIT)

A Dose-Escalation Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Umbilical Cord Blood Megakaryocyte Injection (XJ-MK-002) in Patients With Cancer Therapy-Induced Thrombocytopenia (CTIT)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

XJ-MK-002 injection is a cord blood-derived megakaryocyte suspension, which, following intravenous infusion, undergoes differentiation and fragmentation into platelets under hemodynamic shear stress and physiological regulation within the in vivo environment, thereby elevating platelet levels. The primary endpoint of this study is: • Incidence and severity of adverse events within 28 days. Secondary endpoints include: * Incidence and severity of adverse events during the trial period; * Evaluation of changes in platelet counts from baseline at 1h, 2h, 4h, D2, D3, D7, D14, and D28 after XJ-MK-002 infusion. Exploratory endpoints comprise: * Assessment of the modified platelet recovery rate (PPR) and corrected count increment (CCI) at 1h, 2h, 4h, D2, D3, D7, D14, and D28 post-infusion of XJ-MK-002; * Investigation of the pharmacokinetic parameters of XJ-MK-002, including but not limited to Cmax, Tmax, and AUC0-t.

Conditions

• Thrombocytopenia
• Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Umbilical Cord Blood Megakaryocyte Injection (XJ-MK-002)	dosage 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.

Timeline

• Start date: 2025-08-28
• Primary completion: 2026-06-01
• Completion: 2026-07-01
• First posted: 2025-08-07
• Last updated: 2025-09-09

Locations

1 site across 1 country: China