Cord blood cells aim to fix Chemo-Caused low platelets
NCT ID NCT07110090
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This early-stage trial is testing a single infusion of cells from umbilical cord blood (called XJ-MK-002) in 16 cancer patients whose platelet counts have dropped due to chemotherapy or other cancer treatments. The main goal is to see if the treatment is safe and tolerable, and to check if it can help raise platelet levels. The study is small and open-label, meaning everyone knows what they are getting, and it uses three different doses to find the safest and most promising one.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- umbilical cord blood megakaryocyte injection (XJ-MK-002)
- What this could lead to
- If it works, this could offer a new way to treat dangerously low platelet counts caused by cancer treatments, reducing the need for platelet transfusions.
- What could go wrong
- This is a very early, small Phase 1 trial with only 16 people, so it is primarily testing safety. The treatment may not raise platelets enough, and there could be side effects like allergic reactions or infection.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 16 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Aug 2025
- Expected to finish
-
Jul 2026
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Subjects aged 18 to 75 years (inclusive) at the time of signing the informed consent, regardless of gender. 2. 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 3. No transfusion of platelets or blood products containing platelet components within 72 hours prior to investigational product administration. 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2. 5. Estimated life expectancy of more than 3 months. 6. Female subjects of childbearing potential (WOCBP) and male subjects with WOCBP partners must agree to use highly effective contraception methods in accordance with ICH M3 (R2) guidelines during the trial and for 6 months after administration. Male subjects must also agree not to donate sperm during this period. WOCBP must have a negative pregnancy test result within 7 days prior to enrollment. Exclusion Criteria: 1. History of platelet transfusion refractoriness. 2. History of severe allergic reactions related to blood transfusion. 3. History of bleeding disorders or thrombocytopenia caused by conditions other than CTIT. 4. Splenomegaly or hypersplenism. 5. 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. 6. Subjects with existing severe bleeding (e.g., cerebral hemorrhage, severe gastrointestinal bleeding, or severe hemoptysis). 7. Subjects with hemophilia or coagulation disorders. 8. History of thromboembolic diseases (deep vein thrombosis, arterial thrombosis) within 6 months before screening, or patients with catheter-related thrombosis within 1 month before screening. 9. History of cardiac diseases within 3 months before screening, or a history of severe cardiovascular diseases (e.g., congestive heart failure (NYHA Class 3/4), known arrhythmias that increase the risk of thromboembolic events (e.g., atrial fibrillation, atrial flutter, unstable angina), coronary stent placement, angioplasty, or coronary artery bypass grafting). 10. Major organ surgery (excluding needle biopsy) or severe trauma within 4 weeks before administration of the investigational product or anticipated major surgery during the trial. 11. 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). 12. Coagulation function abnormalities: activated partial thromboplastin time (APTT) \>1.5× upper limit of normal (ULN); international normalized ratio (INR) \>1.5×ULN. 13. 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. 14. Complete blood count abnormalities: Absolute neutrophils count \<1.0×109/L, hemoglobin \<80g/L (use of erythropoietin infusion therapy according to clinical standards is allowed during screening). 15. Positive serology tests during screening: positive anti-HIV antibody or anti-treponema pallidum specific antibody test; or positive hepatitis C antibody with HCV RNA copy number above the upper limit of normal, positive hepatitis B surface antigen, or history of hepatitis B infection; or positive hepatitis B core antibody with HBV-DNA ≥2000 IU/mL within the last 3 months before screening. 16. Uncontrolled severe chronic or active infection requiring intravenous antibiotic treatment before administration. 17. Subjects with known allergies to the investigational product, its active ingredients, or any of its excipients. 18. 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). 19. History of hematopoietic stem cell transplantation with acute graft-versus-host disease requiring therapeutic intervention. 20. Pregnant or lactating female subjects. 21. Any other medical condition that, in the investigator's judgment, precludes participation in this study or completion of follow-up observations.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Cancer Hospital Chinese Academy of Medical Sciences 17 Panjiayuan Nanli, Chaoyang District
RECRUITINGBeijing, Beijing Municipality, 100021, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can colorectal surgery patients go home in two days?
- Can a personal navigator help young cancer patients through treatment?
- Can a smartwatch predict which cancer patients return to hospital?
- Two-Drug combo aims to stall advanced breast cancer
- Blood thinner flush could boost tumor biopsy success
- Could a frailty score predict which older cancer patients survive intensive care?