Actively Recruiting
Umbilical Cord Blood Megakaryocyte Injection (XJ-MK-002) for Cancer Therapy-Induced Thrombocytopenia (CTIT)
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2025-09-09
16
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Umbilical Cord Blood Megakaryocyte Injection (XJ-MK-002) for Cancer Therapy-Induced Thrombocytopenia (CTIT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 75 years at the time of consent, any gender
- Confirmed malignant tumor diagnosis with thrombocytopenia caused by cancer treatments
- Platelet count between 50 x 10^9/L and 100 x 10^9/L with no bleeding, confirmed by blood tests
- No platelet or blood product transfusion within 72 hours before treatment
- ECOG performance status score of 0 to 2
- Estimated life expectancy over 3 months
- Women of childbearing potential and males with partners of childbearing potential agree to use effective contraception during the trial and for 6 months after; negative pregnancy test within 7 days before enrollment for women
You will not qualify if you...
- History of platelet transfusion refractoriness
- Severe allergic reactions related to blood transfusion
- Bleeding disorders or thrombocytopenia from causes other than cancer therapy
- Splenomegaly or hypersplenism
- Use of thrombopoietin-stimulating drugs within 7 days prior to treatment
- Severe bleeding such as cerebral hemorrhage or severe gastrointestinal bleeding
- Hemophilia or coagulation disorders
- Thromboembolic disease history within 6 months or catheter-related thrombosis within 1 month
- Cardiac diseases within 3 months or severe cardiovascular diseases
- Major organ surgery or severe trauma within 4 weeks before treatment
- Use of anticoagulant or antiplatelet drugs within 7 days before screening
- Abnormal coagulation function (APTT >1.5x ULN, INR >1.5x ULN)
- Liver or kidney function abnormalities beyond specified limits
- Blood count abnormalities: neutrophils <1.0 x 10^9/L, hemoglobin <80 g/L
- Positive tests for HIV, hepatitis B or C infection, or syphilis
- Uncontrolled severe infection requiring intravenous antibiotics
- Known allergies to the investigational product or its components
- Use of similar investigational products within 4 weeks or participation in other clinical trials
- History of hematopoietic stem cell transplantation with active graft-versus-host disease
- Pregnant or breastfeeding women
- Any other medical condition that prevents safe participation or follow-up according to the investigator's judgment
AI-Screening
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Trial Site Locations
Total: 1 location
1
Cancer Hospital Chinese Academy of Medical Sciences 17 Panjiayuan Nanli, Chaoyang District
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
Research Team
N
Ning Li
CONTACT
S
Shuhang Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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