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

Sponsor
Anhui Provincial Hospital
Study ID
NCT07696767
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Jul 10, 2026
Start date
Jul 31, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
7 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: MegaLT Injection
    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.

Primary Outcome Measure

Time to Platelet Engraftment [ Time Frame: From umbilical cord blood transplantation until documented platelet engraftment or the participant's last platelet assessment, assessed up to 6 months following MegaLT infusion. ]

Central Contacts

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