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

NCT ID: NCT06792682

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-14
• Study Completion Date: 2028-02-29

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Umbilical Cord Blood Mononuclear Cells

Group Type: EXPERIMENTAL

Dose escalation

Intervention Type: 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.

Dose extension

Intervention Type: 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.

Interventions

Dose escalation

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.

Intervention Type: BIOLOGICAL

Dose extension

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Age≥18 years old; gender is not limited.

2. 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.

3. Eastern Cooperative Oncology Group (ECOG) physical status score ≤ 2 points.

4. Subjects sign informed consent.

Exclusion Criteria

1. Serious infection not controlled.

2. Active bleeding.

3. Patients with cardiac insufficiency (ejection fraction<50%), or suffering from serious heart disease, including myocardial infarction, cardiac insufficiency, etc.

4. 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).

5. Pregnant or lactating women.

6. Concurrent malignant tumors of other organs.

7. Failure to understand or follow the research protocol.

8. Patients participating in other clinical investigations.

9. Other conditions that the investigators consider inappropriate to participate in the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Hematology & Blood Diseases Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institute of Hematology & Blood Diseases Hospital, China

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

erlie EL Jiang

Role: CONTACT

jiangerlie@ihcams.ac.cn

+86-15122538106

Facility Contacts

jiang erlie

Role: primary

jiangerlie@ihcams.ac.cn

+86-15122538106

Other Identifiers

IIT2024098

Identifier Type: -

Identifier Source: org_study_id