Experimental MegaLT injection targets dangerous low platelets in early trial
NCT ID NCT06534255
First seen Jun 26, 2026 · Last updated Jul 08, 2026 · Updated 3 times
Summary
This early-phase trial tests a new cell therapy called MegaLT for people with dangerously low platelet counts that don't improve after radiation, chemotherapy, or stem cell transplant. Only 10 participants will receive the injection at different doses to check safety and how the body handles it. The study is not yet recruiting and focuses on finding a safe dose, not proving it works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- MegaLT injection (a cell therapy)
- What this could lead to
- If it works, this could point toward a new treatment for dangerously low platelet counts that don't respond to standard care.
- What could go wrong
- This is a very early, tiny Phase 1 trial with only 10 people. It primarily checks safety, not effectiveness. The treatment may not work or could cause side effects like graft-versus-host disease.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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10 people
The number who actually took part.
- Started
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Dec 2024
- Finished
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May 2026
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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4 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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: * Age between 4 and 75 years (inclusive) at screening; gender is not restricted; * 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: * Patients with any malignant tumor relapse; * 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.
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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.
Contacts and locations
Locations
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The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Hefei, Anhui, 230036, China