Prophylaxis of Graft-versus-host Disease With Anti-CD25 Antibody in Patients Underwent HSCT

Wang Xin

Status and phase: Not yet enrolling; Phase 2

Conditions: GVHD

Treatments: Drug: low-dose ATG; Drug: CD25 treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT06334367

SWYX:NO.2022-1028

Details and patient eligibility

About

The risk of Graft-versus-host Disease(GVHD) is significantly associated with the mortality rate of patients undergoing allogeneic hematopoietic stem cell transplantation. The occurrence of GVHD increases the hospitalization rate and economic burden of patients. In order to explore better methods for controlling GVHD, we designed a clinical trial using CD25 monoclonal antibody for GVHD prevention. Our previous studies have shown that reduced-dose anti-thymocyte globulin(ATG) in the conditioning regimen can achieve the same effect as full-dose ATG. Here, we try to explore the preventive effect of CD25 antibody on acute and chronic GHVD under low-dose ATG pretreatment condition.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with a clear diagnosis of hematologic disease, weighing ≥30kg, aged 18-60, of any gender and race;
• Willing to undergo haploidentical hematopoietic stem cell transplantation;
• Voluntarily participate in this study;
• Each subject must sign an informed consent form (ICF) indicating their understanding of the purpose and procedures of the study, and their willingness to participate. Considering the patient 's condition, if the patient' s signature is unfavorable for disease treatment, the informed consent form should be signed by the legal guardian or the patient 's immediate family member.

Exclusion criteria

• Those with severe organ dysfunction or diseases, such as heart, liver, kidney, and pancreatic diseases;
• Patients who cannot tolerate CD25 monoclonal antibody treatment;
• Subjects and/or authorized family members who refuse allo-HSCT treatment;
• Any life-threatening diseases, physical conditions, or organ system dysfunctions that the researcher believes may jeopardize the safety of the subject and pose unnecessary risks to the study; drug dependence; uncontrolled mental illness in subjects; cognitive dysfunction;
• Those who have participated in other similar clinical studies within the past 3 months;
• Those deemed unsuitable for inclusion by the researcher (such as patients expected to be unable to adhere to treatment due to financial issues, etc.).

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

CD25 treatment

Experimental group

Description:

The humanized CD25 antibody was administered at 1 mg/kg iv on days+4 and +7 after HSCT.

Treatment:

Drug: CD25 treatment

Drug: low-dose ATG

control group

Other group

Treatment:

Drug: low-dose ATG