NCT04738981

Brief Summary

Randomized, open-label, multicenter study to investigate the efficacy and safety of umbilical cord-derived mesenchymal stem cells (UC-MSC) for the treatment of steroid-resistant acute graft-versus-host disease (aGVHD) following allogeneic hematopoietic stem cell transplantation (allo-HSCT), with a view to establishing an effective treatment protocol for steroid-resistant aGVHD.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 4, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2022

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2023

Completed
Last Updated

June 1, 2023

Status Verified

May 1, 2023

Enrollment Period

1.3 years

First QC Date

February 1, 2021

Last Update Submit

May 31, 2023

Conditions

Graft Vs Host Disease

Outcome Measures

Primary Outcomes (1)

  • Rate of complete remission

    Complete remission of aGVHD related symptoms and indicators

    4 weeks after treatment

Secondary Outcomes (3)

  • Overall survival

    At the end of Week 4 / 8 / 12 / 24 / 52.

  • Rate of partial remission

    4 weeks after treatment

  • Infusion toxicity

    From the beginning of to four hours after every infusion of UC-MSC

Study Arms (2)

UC-MSC and anti-CD25 mAb

EXPERIMENTAL

UC-MSC, iv, 1×10\^6 cells/kg, once a week, for 4 weeks. Anti-CD25 mAb, iv, 20mg，twice in first week and once a week thereafter, 4 weeks. Other treatment would replace it according to clinical experience if aGVHD continue to progress within 3 weeks of treatment or patients are lack of response after 4 weeks of treatment. The treatment would be repeated in another 4 weeks if patients receive partial response after the first 4 weeks of treatment.

Drug: UC-MSCDrug: Anti-CD25 mAb

Anti-CD25 mAb

ACTIVE COMPARATOR

Anti-CD25 mAb, iv, 20mg，twice in first week and once a week thereafter, for 4 weeks. Other treatment would replace it according to clinical experience if aGVHD continue to progress within 3 weeks of treatment or patients are lack of response after 4 weeks of treatment. The treatment would be repeated in another 4 weeks if patients receive partial response after first 4 weeks of treatment.

Drug: Anti-CD25 mAb

Interventions

UC-MSCDRUG

UC-MSC, iv, 1×10\^6 cells/kg, once a week, for 4 weeks.

Also known as: Umbilical cord-derived mesenchymal stem cells
UC-MSC and anti-CD25 mAb
Anti-CD25 mAbDRUG

Anti-CD25 mAb, iv, 20mg，twice in first week and once a week thereafter, for 4 weeks.

Also known as: Basiliximab
Anti-CD25 mAbUC-MSC and anti-CD25 mAb

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed diagnosed steroid-resistant aGVHD after allo-HSCT. 2. Neutrophile granulocyte (ANC) ≥ 0.5 x 10\^9/L. 3. Creatinine below 2 times normal upper limit . 4. Willing and able to sign written informed consent.

You may not qualify if:

  • \- 1. Untoleratation of the treatment. 2. Primary disease are not effectively controlled or are progressing. 3. Active infection (Bacteria, fungi, viruses ). 4. Combined with dysfunction of multiple organ. 5. Female patients who are nursing or pregnant, or who contemplate pregnancy during the study period.
  • \. Patients who are deemed unsuitable for the study by the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Insititute of Hematology, Peking University People's Hospital

Beijing, Beijing Municipality, 100010, China

Location

Related Publications (1)

  • Fu H, Sun X, Lin R, Wang Y, Xuan L, Yao H, Zhang Y, Mo X, Lv M, Zheng F, Kong J, Wang F, Yan C, Han T, Chen H, Chen Y, Tang F, Sun Y, Chen Y, Xu L, Liu K, Zhang X, Liu Q, Huang X, Zhang X. Mesenchymal stromal cells plus basiliximab improve the response of steroid-refractory acute graft-versus-host disease as a second-line therapy: a multicentre, randomized, controlled trial. BMC Med. 2024 Feb 27;22(1):85. doi: 10.1186/s12916-024-03275-5.

    PMID: 38413930DERIVED

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

PC61 monoclonal antibodyBasiliximab

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Xiaohui Zhang, doctor

    Peking University People's Hospital, Peking University Insititute of Hematology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice president of Peking Univeristy Institute of Hematology

Study Record Dates

First Submitted

February 1, 2021

First Posted

February 4, 2021

Study Start

February 1, 2021

Primary Completion

May 30, 2022

Study Completion

May 2, 2023

Last Updated

June 1, 2023

Record last verified: 2023-05

Locations

CN(1)