AbataceptPhase 1/2NCT04686929
Abatacept s.c. for aGVHD Prevention in Haplo-HCT
A Phase 1/2 study testing Abatacept s.c. in people with Abatacept and Acute-graft-versus-host Disease, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abatacept, Acute-graft-versus-host Disease, Haplo-identical HCT
- What is being tested?
- Abatacept s.c.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2021to 31 Jan 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age≧18 years
- ECOG score 0-2 / Karnofsky score≧80
- haplo-HCT is proposed
- Conditioning with motified Bu/Cy+ATG regimen
- Having the following hematologic malignancies with transplant indications:
- Acute leukemia
Show all 11Show fewer
- Myelodysplastic syndrome
- Aggressive lymphoma
- Expected survival ≥ 3 months
- Written informed Consent can be acquired
- Agree to use effective contraception
Who cannot join
- With a history of allo-HCT previously
- Allergic/intolerant to Abatacept
- Contraindications to the use of Abatacept
- HIV infection, or active HBV infection or HCV infection
- Uncontrolled active infection
- Vital organ function intolerated to transplantation
Show all 10Show fewer
- 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
- 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)
- Pregnant and lactational women
- Any life-threatening disease, medical condition, or organ dysfunction unfit for participants, or may interfere with the absorption or metabolism of Abatacept
Trial locations and contacts
1 site in 1 country.
China1 site
the First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
About this study
Official title: The Efficacy and Safety of Subcutaneous Abatacept in the Prevention of Acute Graft-versus-host Disease After Haplo-identical Donor Hematopoietic Cell Transplantation
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.
- Being tested
- Abatacept s.c.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abatacept s.c.Drug
subcutaneous abatacept: 250mg (d-1) , 125mg (d+5, +14, +21, +28, +35, +42, +49, +56) combined with CsA, MTX, MMF.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | The participants in Cohort 1 will receive abatacept s.c Receives: Drug: Abatacept s.c. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of overt aGVHD
The incidence of grade II-IV aGVHD post-transplantation
Measured: 100 days post-HCT
Secondary outcomes (4)
Incidence of aGVHD
The incidence of grade I-IV aGVHD post-transplantation
Measured: 100 days post-HCT
Incidence of severe aGVHD
The incidence of grade III-IV aGVHD post-transplantation
Measured: 100 days post-HCT
Early transplant-related mortality
The incidence of early transplant-related mortality
Measured: 100 days post-HCT
Relapse
The incidence of relapse/progression of underlying disease
Measured: 100 days post-HCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start1 Jun 2021
- Primary completion31 May 2023
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AbataceptStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CHEN Jia, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04686929
- Sponsor's protocol ID
- SZ9102
- Status last verified
- Jun 2026
- First submitted
- 23 Dec 2020
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Subcutaneous Abatacept in the Prevention of Acute Graft-versus-host Disease After Haplo-identical Donor Hematopoietic Cell Transplantation
- ClinicalTrials.gov ID
- NCT04686929
- Acronym / sponsor ID
- SZ9102
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 29 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Abatacept s.c.The participants in Cohort 1 will receive abatacept s.c |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age≧18 years
- ECOG score 0-2 / Karnofsky score≧80
- haplo-HCT is proposed
- Conditioning with motified Bu/Cy+ATG regimen
- Having the following hematologic malignancies with transplant indications:
Key exclusion criteria (10 listed)
- With a history of allo-HCT previously
- Allergic/intolerant to Abatacept
- Contraindications to the use of Abatacept
- HIV infection, or active HBV infection or HCV infection
- Uncontrolled active infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abatacept s.c.subcutaneous abatacept: 250mg (d-1) , 125mg (d+5, +14, +21, +28, +35, +42, +49, +56) combined with CsA, MTX, MMF. | Drug | Cohort 1 |
Primary outcome
Incidence of overt aGVHD
Time frame: 100 days post-HCT
The incidence of grade II-IV aGVHD post-transplantation
4 secondary outcomes
Incidence of aGVHD
Time frame: 100 days post-HCT
Incidence of severe aGVHD
Time frame: 100 days post-HCT
Early transplant-related mortality
Time frame: 100 days post-HCT
Relapse
Time frame: 100 days post-HCT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Abatacept s.c. in people with Abatacept and Acute-graft-versus-host Disease, run by The First Affiliated Hospital of Soochow University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of overt aGVHD (time frame: 100 days post-HCT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.