The Safety and Efficacy of Umbilical Cord Blood Mononuclear Cells in Patients With Secondary Poor Graft Function After Hematopoietic Stem Cell Transplantation

NCT06792682 | Recruiting Phase 1

• 1 other identifier: IIT2024098
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This study is conducted in a prospective, single-center clinical design and is divided into two stages: dose escalation and dose extension. Patients meeting the diagnostic criteria of secondary poor graft function are selected as the study objects. The safety data of umbilical cord blood mononuclear cells in the treatment of secondary poor graft function are obtained through dose escalation stage, and then one dose is selected for dose extension stage to explore the efficacy of umbilical cord blood mononuclear cells in treating secondary poor graft function.

Conditions

Poor Graft Function

Keywords

Secondary poor graft function; Umbilical cord blood mononuclear cells

Outcome Measures

Primary Outcomes (1)

• Safety assessment

  Incidence of adverse events

  From date of the last infusion of umbilical cord blood mononuclear cells until the date of end of follow-up, assessed up to 24 months

Secondary Outcomes (2)

• The recovery time of platelet

  Two months after the last infusion of umbilical cord blood mononuclear cells

• The recovery time of neutrophil

  Two months after the last infusion of umbilical cord blood mononuclear cells

Study Arms (1)

Umbilical Cord Blood Mononuclear Cells

EXPERIMENTAL

Biological: Dose escalation; Biological: Dose extension

Interventions

Dose escalation BIOLOGICAL

Three dose groups are preset. The doses are 2.0×10\^6/kg/time, 3.5×10\^6/kg/time and 5.0×10\^6/kg/ time respectively, in accordance with the "3+3" dose escalation principle, and proceed in turn. Each subject receives conventional treatment plus umbilical cord blood mononuclear cells therapy, with 4 consecutive intravenous infusions of umbilical cord blood mononuclear cells at 1 week intervals.

Umbilical Cord Blood Mononuclear Cells

Dose extension BIOLOGICAL

According to the safety data of dose escalation stage, one dose group is selected for extension. Each subject receives conventional treatment plus umbilical cord blood mononuclear cells therapy, with 4 consecutive intravenous infusions of umbilical cord blood mononuclear cells at 1 week intervals.

Umbilical Cord Blood Mononuclear Cells

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 old; gender is not limited.
• Meet the diagnostic criteria for secondary poor graft function: After 28 days of transplantation, patients who had achieved hematopoietic reestablishment (ANC ≥ 0.5×10\^9/L for 3 consecutive days without G-CSF application, PLT ≥ 20×10\^9/L for 7 consecutive days without platelet infusion, Hb ≥ 80g/L for 2 consecutive weeks without red blood cell infusion) again developed two or three line cytopenia lasting more than 2 weeks. Bone marrow examination revealed low myelodysplasia, remission of primary disease, complete donor chimeric cells, and no severe graft-versus-host disease (GVHD) or disease recurrence.
• Eastern Cooperative Oncology Group (ECOG) physical status score ≤ 2 points.
• Subjects sign informed consent.

You may not qualify if:

• Serious infection not controlled.
• Active bleeding.
• Patients with cardiac insufficiency (ejection fraction\<50%), or suffering from serious heart disease, including myocardial infarction, cardiac insufficiency, etc.
• Patients with hepatic and renal insufficiency (total bilirubin\>35µmol/L, ALT and AST\>2 times of the upper limit of normal; serum creatinine\>130µmol/L).
• Pregnant or lactating women.
• Concurrent malignant tumors of other organs.
• Failure to understand or follow the research protocol.
• Patients participating in other clinical investigations.
• Other conditions that the investigators consider inappropriate to participate in the study.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

Institute of Hematology & Blood Diseases Hospital, China

Tianjin, Tianjin Municipality, 300020, China

RECRUITING

Central Study Contacts

erlie EL Jiang

CONTACT

+86-15122538106; jiangerlie@ihcams.ac.cn

Study Design

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

Study Record Dates

• First Submitted: December 27, 2024
• First Posted: January 27, 2025
• Study Start: February 14, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: March 13, 2025

Record last verified: 2025-01

Locations

CN (1)