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CompletedNCT04686929Updated Jun 11, 2026

Abatacept s.c. for aGVHD Prevention in Haplo-HCT

A Phase 1/2 interventional study of Abatacept s.c. in Abatacept, Acute-graft-versus-host Disease and Haplo-identical HCT, sponsored by The First Affiliated Hospital of Soochow University. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-11.

Sponsored by The First Affiliated Hospital of Soochow University · Phase 1/2, Interventional, and Prevention

Phase
Phase 1/2
Study type
Interventional
Enrollment
29
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Acute graft-versus-host disease (aGVHD) is a potentially fatal complication after allogeneic hematopoietic cell transplantation (HCT), particularly for that with a HLA-mismatched donor. Abatacept has been demonstrated as a potent drug to reduce the risk of aGVHD, but the efficacy of subcutaneous form has yet been investigated. This trial is designed to preliminarily determin the efficacy and saftey of subcutaneous abatacept in the prevention of aGVHD after haplo-identical HCT.

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Conditions studied

  • Abatacept
  • Acute-graft-versus-host Disease
  • Haplo-identical HCT
  • Prevention
03

In context

Lead sponsor

The First Affiliated Hospital of Soochow University is the lead sponsor of 252 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age≧18 years
  2. ECOG score 0-2 / Karnofsky score≧80
  3. haplo-HCT is proposed
  4. Conditioning with motified Bu/Cy+ATG regimen
  5. Having the following hematologic malignancies with transplant indications:

    1. Acute leukemia
    2. Myelodysplastic syndrome
    3. Aggressive lymphoma
  6. Expected survival ≥ 3 months
  7. Written informed Consent can be acquired
  8. Agree to use effective contraception

Exclusion criteria

Exclusion Criteria:

  1. With a history of allo-HCT previously
  2. Allergic/intolerant to Abatacept
  3. Contraindications to the use of Abatacept
  4. HIV infection, or active HBV infection or HCV infection
  5. Uncontrolled active infection
  6. Vital organ function intolerated to transplantation
  7. Other malignancies except for the following diseases: malignant tumors that have been cured for at least 3 years without active lesions; adequete treated non-melanoma skin cancer, malignant amygdala, and carcinoma in situ without active lesions
  8. Evidence of complications or medical conditions that may interfere with research or put the subjects at serious risk, including but not limited to severe cardiovascular disease (e.g. New York Heart Association grade III or IV heart disease, myocardial infarction in the past 6 months, unstable arrhythmia or unstable angina) and/or severe lung disease (e.g. history of severe obstructive lung disease and symptomatic bronchospasm)
  9. Pregnant and lactational women
  10. Any life-threatening disease, medical condition, or organ dysfunction unfit for participants, or may interfere with the absorption or metabolism of Abatacept
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
29 participants (actual)

Study arms

  • Experimental
    Cohort 1

    The participants in Cohort 1 will receive abatacept s.c

    Drug: Abatacept s.c.

Interventions

  • DrugAbatacept s.c.

    subcutaneous abatacept: 250mg (d-1) , 125mg (d+5, +14, +21, +28, +35, +42, +49, +56) combined with CsA, MTX, MMF.

06

What researchers measure

Primary outcomes

  1. Incidence of overt aGVHD

    The incidence of grade II-IV aGVHD post-transplantation

    Time frame: 100 days post-HCT

Secondary outcomes

  1. Incidence of aGVHD

    The incidence of grade I-IV aGVHD post-transplantation

    Time frame: 100 days post-HCT

  2. Incidence of severe aGVHD

    The incidence of grade III-IV aGVHD post-transplantation

    Time frame: 100 days post-HCT

  3. Early transplant-related mortality

    The incidence of early transplant-related mortality

    Time frame: 100 days post-HCT

  4. Relapse

    The incidence of relapse/progression of underlying disease

    Time frame: 100 days post-HCT

Other outcomes

  1. Engraft failure

    Failed to engraft with donor cells

    Time frame: 100 days post-HCT

  2. Blood cell recovery

    Neutrophil count recover to 1000/ul and platelet count recover to 20000/ul

    Time frame: 100 days post-HCT

07

Study locations

1 site
  • the First Affiliated Hospital of Soochow University
    Suzhou, Jiangsu 215006, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04686929
Lead sponsor
The First Affiliated Hospital of Soochow University
Responsible party
CHEN Jia (M.D., The First Affiliated Hospital of Soochow University) — Principal investigator
First posted
Dec 29, 2020
Start date
Jun 1, 2021
Primary completion
May 31, 2023
Completion
Jan 31, 2026
Last update
Jun 11, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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