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Experimental MegaLT injection targets dangerous low platelets in early trial

NCT ID NCT06534255

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

10 people

The number who actually took part.

Started

Dec 2024

Finished

May 2026

Lead sponsor

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

4 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

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

  • The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)

    Hefei, Anhui, 230036, China