UCMSC-Exo for Chemotherapy-induced Myelosuppression in Acute Myeloid Leukemia

NCT06245746 | Recruiting Phase 1

• 1 other identifier: UHCT231013
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to explore the safety and efficacy of UCMSC-Exo in consolidation chemotherapy-induced myelosuppression in patients with acute myeloid leukemia after achieving complete remission.

Conditions

Acute Myeloid Leukemia; Neutropenia; Anemia; Thrombocytopenia; Infections; Bleeding

Keywords

umbilical cord derived mesenchymal stem cells exosomes; chemotherapy-induced myelosuppression; neutropenia; anemia; thrombocytopenia; infections; bleeding; acute myeloid leukemia; chemotherapy

Outcome Measures

Primary Outcomes (3)

• Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

  To investigate the safety characteristics, percentages will be calculated and grade will be evaluated.

  From the day that UCMSC-Exo is infused to up to 28 days (short-term safety follow-up) and 1 year (long-term safety follow-up)

• Dose-limiting toxicities（DLT)

  During the DLT observation period, the subject has an adverse event that is reasonably related to UCMSC-Exo infusion (possibly, likely or definitely related).

  From the day that UCMSC-Exo is infused to up to 14 days

• Maximum tolerated dose (MTD)

  During the dose-escalation, the highest dose of dose-limiting toxicity for subjects no more than 1/6 in the dose group of at least 6 evaluable subjects of the study drug.

  From the day that UCMSC-Exo is infused to up to 14 days

Secondary Outcomes (13)

• Time to absolute neutrophil count recovery

  From the start of chemotherapy to up to 42 days

• Incidence of febrile neutropenia

  From the start of chemotherapy to up to 42 days

• Duration of febrile neutropenia

  From the start of chemotherapy to up to 42 days

• Incidence of severe thrombocytopenia

  From the start of chemotherapy to up to 42 days

• Time to severe thrombocytopenia recovery

  From the start of chemotherapy to up to 42 days

Study Arms (1)

UCMSC-Exo intervention

EXPERIMENTAL

UCMSC-Exo will be preset with 3 escalation dose levels in single time infusion.

Biological: umbilical cord derived mesenchymal stem cells exosomes (UCMSC-Exo)

Interventions

umbilical cord derived mesenchymal stem cells exosomes (UCMSC-Exo) BIOLOGICAL

UCMSC-Exo will be infused intravenously.

UCMSC-Exo intervention

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Aged between 18 and 60 years old;
• Acute myeloid leukemia (AML, AML subtype M3 excluded) diagnosed according to the 2022 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia, who have achieved complete remission (CR1) and are going to receive consolidation therapy (cytarabine or cytarabine-based combined regimen, the cycle of consolidation therapy is not limited);
• The participant or his/her legal guardian is adequately informed of the nature and risks of the study, voluntarily participates in the study with signed informed consent;
• Male or female;
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2 (by the day chemotherapy is initiated)
• Estimated survival of at least 3 months;
• Adequate major organ function:
• Respiratory function: indoor oxygen saturation of at least 95%;
• Cardiac function: ejection fraction of left ventricular of at least 45%;
• Hepatic function: alanine aminotransferase/aspartate aminotransferase of at most 2.5 times/upper limit of normal value and serum total bilirubin of at most 1.5 times/upper limit of normal value;
• Renal function: Serum creatinine of at most 1.5 times/upper limit of normal value;
• Participants who do not receive any type of anti-cancer therapy within 2 weeks before enrollment (radiation therapy, chemotherapy and/or immune therapy, et al.), and treatment-associated toxicities induced by previous therapy has recovered to Grade 1 or below (except for low grade toxicities such as alopecia).
• For female participants, they should be surgical sterilized or post-menopausal, or agree to utilize a medically recognised method of contraception (such as intrauterine device, condom) during treatment period of the study and within 6 months after the end of treatment period of the study; For male participants, they should be surgical sterilized or agree to utilize a medically recognised method of contraception (such as intrauterine device, condom) during treatment period of the study and within 6 months after the end of treatment period of the study;

You may not qualify if:

• Central nervous system manifestations of acute myeloid leukemia at diagnosis;
• Secondary acute myeloid leukemia;
• Myelosuppression induced by conditions other than anti-cancer therapy;
• Previous radiation therapy performed on sternum or pelvis;
• Specifically diagnosed and uncontrolled infection at enrollment (Uncontrolled is defined as exhibiting ongoing signs and symptoms of infection without improvement despite anti-infective agents) ;
• Uncontrolled active bleeding at enrollment;
• Severe underlying comorbidities affecting survival, including cachexia, severe malnutrition, etc;
• Estimated survival of at most 48 hours;
• Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection;
• History of or current human immunodeficiency virus (HIV) infection;
• Syphilis infection;
• Continuous usage of immunosuppressants or received organ transplantation in the last 6 months;
• Participation in clinical trials of other drugs within 6 weeks before enrollment;
• Previous participation in clinical stem cell or exosome research;
• Receive any agent concurrently with UCMSC-Exo infusion which inhibits cell division (hydroxyurea, low-dose cytarabine or methotrexate, etc) ;

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

Wuhan Union Hospital

Wuhan, Hubei, 430000, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Neutropenia; Anemia; Thrombocytopenia; Infections; Hemorrhage

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Agranulocytosis; Leukopenia; Cytopenia; Leukocyte Disorders; Blood Platelet Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Qiubai Li, Professor

  Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qiubai Li, Professor

CONTACT

85726808; qiubaili@hust.edu.cn

Di Wu

CONTACT

18790696175; 373181302@qq.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. & Ph.D., Professor

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 7, 2024
• Study Start: February 26, 2025
• Primary Completion: February 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)