A Clinical Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of MegaLT Injection for Treating Refractory Thrombocytopenia Following Radiotherapy, Chemotherapy, or Transplantation.
NCT ID: NCT06534255
Last Updated: 2024-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
10 participants
INTERVENTIONAL
2024-12-04
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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MegaLT injection
Dosage Form: ex vivo three-dimensional induced umbilical cord blood mononuclear cells differentiated megakaryocyte injection (MegaLT injection).
Administration Route: Intravenous Infusion Regimen: Single or Multiple Infusions
MegaLT injection
Three dose groups were set: 1×10\^6/kg, 5×10\^6/kg, and 1×10\^7/kg. The dose escalation was carried out in ascending order using a "3+3" design. To ensure participant safety, enrollment followed a "1+2" rule. Specifically, the first participant in each dose group received the cell infusion and was observed for 14 days. If no dose-limiting toxicity (DLT) was observed, the remaining two participants could then be enrolled and receive cell therapy at the same dose level.
Interventions
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MegaLT injection
Three dose groups were set: 1×10\^6/kg, 5×10\^6/kg, and 1×10\^7/kg. The dose escalation was carried out in ascending order using a "3+3" design. To ensure participant safety, enrollment followed a "1+2" rule. Specifically, the first participant in each dose group received the cell infusion and was observed for 14 days. If no dose-limiting toxicity (DLT) was observed, the remaining two participants could then be enrolled and receive cell therapy at the same dose level.
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with refractory thrombocytopenia following radiotherapy/chemotherapy or transplantation;
* Adequate organ function：Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) \< 2.5\*upper limit of normal (ULN); Serum creatinine \< 1.5\* ULN; Total bilirubin level \< 1.5\* ULN; Coagulation function: International Normalized Ratio (INR) ≤ 1.5\* ULN, Activated Partial Thromboplastin Time (APTT) ≤ 1.5\*ULN; Hemoglobin ≥ 60 g/L, or hemoglobin maintained at this level after transfusion; Absolute neutrophil count (ANC) ≥ 1.0×10\^9/L;
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
* Voluntarily participating in the clinical trial, with full understanding of the trial details and having signed the informed consent form.
Exclusion Criteria
* Pregnant or breastfeeding women;
* Life expectancy less than 3 months;
* Severe infections or severe concurrent conditions such as heart, liver, lung, kidney, neurological, or metabolic diseases;
* History of severe thrombotic events or known thrombotic risk factors. Exceptions: Participants for whom the potential benefits of the study, as determined by the investigator, outweigh the potential risks of thromboembolic events;
* Uncontrolled infectious or other serious diseases, including but not limited to infections (e.g., HIV positive), congestive heart failure, unstable angina, arrhythmias, psychiatric disorders, or conditions that limit the ability to meet study requirements or pose unpredictable risks as judged by the primary physician;
* Active hepatitis B or C infection;
* Refractory thrombocytopenia post-transplant with Grade III-IV acute graft-versus-host disease (GVHD) \[according to NIH standards\] or severe chronic GVHD (NIH 2014 standards);
* History of organ transplantation or planned organ transplantation (excluding hematopoietic stem cell transplantation);
* Participation in another clinical study within 30 days prior to the baseline visit, involving any investigational drug or device; observational studies are allowed;
* Any other conditions deemed by the investigator to make the participant unsuitable for the clinical trial.
4 Years
75 Years
ALL
No
Sponsors
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Anhui Provincial Hospital
OTHER_GOV
Responsible Party
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Principal Investigators
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Xiaoyu Zhu, Ph.D
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of University of Science and Technology of China
Locations
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The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Hefei, Anhui, China
Countries
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Central Contacts
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Facility Contacts
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Xiaoyu Zhu, Ph.D
Role: primary
Aijie Huang, M.D
Role: backup
Other Identifiers
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MegaLT-2024
Identifier Type: -
Identifier Source: org_study_id