Using a monoclonal antibody to prevent graft-versus-host disease in thalassemia patients after stem cell transplantation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of a recombinant humanized anti-CD25 monoclonal antibody in preventing graft-versus-host disease (GVHD) in patients with transfusion-dependent thalassemia undergoing haploidentical or matched unrelated donor hematopoietic stem cell transplantation. Participants will be randomly assigned to receive either the monoclonal antibody or a control treatment. The study aims to determine the incidence of GVHD and assess the safety and quality of life of participants over a two-year follow-up period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* patients with transfusion-dependent thalassemia;
* patients who are planning to receive matched unrelated donor hematopoietic stem cell transplantation (MUD-HSCT) or HLA haploidentical donor hematopoietic stem cell transplantation (HID-HSCT);
* physical condition score (Lansky/Karnofsky score) ≥ 70%;
* patients (or legal guardians) voluntarily participate in the study and sign the informed consent form

Exclusion Criteria:

* patients with HLA-matched hematopoietic stem cell donors and willing to receive HLA-matched hematopoietic stem cell transplantation;
* patients with known infectious diseases such as hepatitis B, hepatitis C, AIDS, syphilis, human T-lymphotropic virus, etc.;
* patients with serious active bacterial, viral, fungal, malaria or parasitic infections;
* patients with autoimmune deficiency diseases;
* patients with a history of malignant tumors or current malignant tumors;
* patients with important organ diseases or abnormal laboratory tests, including but not limited to: 1) patients with cirrhosis, liver fibrosis or active hepatitis, and/or abnormal liver function tests (alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥2.5×ULN; alkaline phosphatase ≥2.5×ULN); 2) patients with heart disease, or left ventricular ejection fraction (LVEF) \<60%, or severe iron deposition in the heart; 3) kidney disease, or blood creatinine ≥1.5×ULN with creatinine clearance \<30% of normal level; 4) patients with endocrine dysfunction;
* patients with uncorrected bleeding disease;
* patients with severe mental illness (such as severe depression, schizophrenia, etc.) or cognitive dysfunction (dementia, delirium, etc.), which are unable to cooperate with the study;
* peripheral blood white blood cell (WBC) count \<3×10\^9/L or platelet count \<100×10\^9/L;
* patients having received thalidomide treatment within the past 3 months;
* patients having received any type of gene and/or cell therapy in the past;
* patients with severe allergies;
* female patients who are pregnant, breastfeeding, or planning to become pregnant within 1 year of participating in this trial;
* patients who are participating in other clinical trials;
* other situations that are not suitable for participation in this clinical trial as assessed by the investigator.

Where it's running

• Maoming People's Hospital
  Maoming, Guangdong, China Recruiting
• Liuzhou Workers' Hospital
  Liuzhou, Guangxi, China Recruiting
• The First Affiliated Hospital of Guangxi Medical University
  Nanning, Guangxi, China Recruiting
• Yulin Red Cross Hospital
  Yulin, Guangxi, China Recruiting
• Hainan Provincial People's Hospital
  Haikou, Hainan, China Recruiting

Study contacts

• Study coordinator: Rongrong Liu
• Email: liurongrong@stu.gxmu.edu.cn
• Phone: +86 0771 5356510

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Evaluating GMCN-508A for treating transfusion-dependent α-thalassemia

  This study is testing a new treatment using a patient's own stem cells to see if it can help young people with transfusion-dependent α-thalassemia live healthier lives.

  Recruiting Phase 1 First Affiliated Hospital of Guangxi Medical University · Nanning, Guangxi · NCT05757245

• Gene-modified stem cell therapy for transfusion-dependent beta-thalassemia

  A small, early-phase study will test a one-time infusion of a patient’s own genetically edited stem cells to see if it reduces transfusion needs in adults and children with transfusion-dependent beta-thalassemia.

  Recruiting at 2 sites Phase 2 Fondazione Telethon · Rome, Lazio and 1 other locations · NCT07680803

• Mitapivat for pediatric transfusion-dependent thalassemia (α- or β-TDT)

  This pediatric trial tests whether mitapivat can reduce or lessen the need for transfusions in children with transfusion-dependent alpha- or beta-thalassemia.

  Recruiting at 4 sites Phase 3 Agios Pharmaceuticals, Inc. · Atlanta, Georgia and 3 other locations · NCT07506863

• Treatment for Beta-Thalassemia using KL003 Cell Injection

  This study is testing a new gene therapy using KL003 cell injections to see if it can help young people with severe beta-thalassemia reduce their need for blood transfusions.

  Recruiting at 2 sites Phase 1/2 Kanglin Biotechnology (Hangzhou) Co., Ltd. · Shanghai, Shanghai Municipality and 1 other locations · NCT06280378

• Comparing growth and development in children with beta-thalassemia after gene therapy

  This study looks at how gene therapy affects the growth and development of children with beta-thalassemia compared to those getting regular treatments and healthy kids.

  Recruiting Institute of Hematology & Blood Diseases Hospital, China · Tianjin, Tianjin Municipality · NCT05991336

• Evaluating a new gene therapy for transfusion-dependent beta-thalassemia

  This study is testing a new gene therapy to see if it can help people with transfusion-dependent beta-thalassemia reduce or stop their need for regular blood transfusions.

  Recruiting Early Phase 1 First Affiliated Hospital of Guangxi Medical University · Nanning, Guangxi · NCT05762510

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.