Efficacy and Safety of MegaLT Injection for Platelet Recovery After Umbilical Cord Blood Transplantation

NCT07696767 | Not Yet Recruiting Early Phase 1

• 1 other identifier: MegaLT-2026
• Study Type: interventional
• Target: 7
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a single-arm, early safety and feasibility exploratory study to evaluate the efficacy and safety of MegaLT Injection in promoting platelet recovery after umbilical cord blood transplantation. Adults with malignant hematologic diseases who undergo umbilical cord blood transplantation will receive a single intravenous infusion of MegaLT Injection on day 14 after transplantation. Two dose levels will be evaluated sequentially, and platelet recovery, platelet transfusion requirements, and safety outcomes will be assessed.

Conditions

Thrombocytopenia; Hematologic Malignacies; Platelet Recovery After Umbilical Cord Blood Transplantation

Keywords

MegaLT Injection; Umbilical Cord Blood Transplantation; Platelet Recovery; Platelet Engraftment; Thrombocytopenia

Outcome Measures

Primary Outcomes (2)

• Time to Platelet Engraftment

  Platelet engraftment is defined as the first day of 7 consecutive days with platelet count ≥20×10\^9/L without platelet transfusion.

  From umbilical cord blood transplantation until documented platelet engraftment or the participant's last platelet assessment, assessed up to 6 months following MegaLT infusion.

• Platelet Engraftment by Day 28

  Cumulative incidence of platelet engraftment by day 28 after transplantation, defined as 7 consecutive days with platelet count ≥20×10\^9/L without platelet transfusion.

  At day 28 after umbilical cord blood transplantation

Secondary Outcomes (5)

• Platelet Recovery by Day 28

  At day 28 after umbilical cord blood transplantation

• Time to Platelet Count Thresholds

  From umbilical cord blood transplantation until documented platelet count recovery at each threshold or the participant's last platelet assessment, assessed up to 6 months following MegaLT infusion.

• Platelet Transfusion Volume

  From MegaLT Injection to 4 weeks after injection

• Neutrophil Engraftment by Day 28

  At day 28 after umbilical cord blood transplantation

• Megakaryocyte Level in Bone Marrow

  At 4 weeks after MegaLT Injection

Other Outcomes (6)

• Adverse Events

  From MegaLT Injection to 6 months after injection

• Bleeding Events

  From MegaLT Injection to 6 months after injection

• Transplant-Related Complications and Mortality

  From umbilical cord blood transplantation to 100 days after transplantation

Study Arms (1)

MegaLT Injection

EXPERIMENTAL

Participants will receive MegaLT Injection by intravenous infusion on day 14 after umbilical cord blood transplantation. Dose escalation will proceed sequentially from 1×10\^6/kg to 2.5×10\^6/kg. Each participant will receive one assigned cell dose; multiple infusions may be considered if necessary according to the protocol.

Biological: MegaLT Injection

Interventions

MegaLT Injection BIOLOGICAL

MegaLT Injection is prepared from eligible umbilical cord blood cells through directed expansion and quality control to obtain a megakaryocyte cell product. Participants will receive MegaLT Injection by intravenous infusion on day 14 after umbilical cord blood transplantation. The assigned dose will be 1×10\^6/kg or 2.5×10\^6/kg, with sequential dose escalation from the low-dose level to the high-dose level. Each participant will receive one assigned cell dose; multiple infusions may be considered if necessary according to the protocol.

MegaLT Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years, male or female.
• Patients with a definite diagnosis of hematologic malignancy who are undergoing umbilical cord blood transplantation.
• Patients at day 14 after umbilical cord blood transplantation.
• ECOG performance status ≤2.
• Patients who voluntarily agree to participate in this clinical trial, fully understand the study content, and sign the informed consent form.

You may not qualify if:

• Patients with relapse of any malignant tumor.
• Pregnant or lactating women.
• Patients with severe infection or severe cardiac, hepatic, pulmonary, renal, neurologic, or metabolic disease.
• Patients with a history of severe thrombotic events or known risk factors for thrombosis. Exception: participants for whom the investigator determines that the potential benefit of study participation outweighs the potential risk of thromboembolic events.
• Patients with uncontrolled infectious disease or other serious diseases, including but not limited to infection such as HIV positivity, congestive heart failure, unstable angina, cardiac arrhythmia, psychosis, social circumstances that would limit compliance with study requirements, or any condition that the treating physician considers may pose unpredictable risks.
• Patients with active hepatitis B or hepatitis C.
• Patients who have previously received organ transplantation or are planning to receive organ transplantation, except for hematopoietic stem cell transplantation.
• Patients who participated in another clinical study and used any investigational drug or device within 30 days before the baseline visit. Participation in observational studies is allowed.
• Patients considered by the investigator to be unsuitable for participation in this clinical trial for any other reason.

Sponsors & Collaborators

• Anhui Provincial Hospital: lead

MeSH Terms

Conditions

Thrombocytopenia

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Central Study Contacts

Xiaoyu Zhu, MD, PhD

CONTACT

+86-551-62282931; xiaoyuz@ustc.edu.cn

Aijie Huang, MD

CONTACT

huangaijie@mail.ustc.edu.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2026
• First Posted: July 10, 2026
• Study Start: July 31, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share