NCT06809712 Human Leukocyte Antigen (HLA) Mismatched Unrelated Allogeneic Hematopoietic Stem Cell Transplantation
| NCT ID | NCT06809712 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | He Huang |
| Condition | Hematologic Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 29 participants |
| Start Date | 2022-08-04 |
| Primary Completion | 2026-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 29 participants in total. It began in 2022-08-04 with a primary completion date of 2026-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is a single center, prospective, single arm exploratory clinical trial that includes patients with hematological malignancies who are indicated for allogeneic hematopoietic stem cell transplantation (allo HSCT) but lack suitable donors. This project plans to use highly mismatched unrelated HLA mismatched donors. Ultimately, an unrelated human leukocyte antigen (HLA) mismatched allo HSCT transplantation plan will be established to improve the disease prognosis of this group of patients and truly enter the era of "everyone has a donor" for allo HSCT.
Eligibility Criteria
Inclusion Criteria: * Adult patients (18-60 years old) with hematological malignancies and indications for hematopoietic stem cell transplantation; * Non blood donors without human leukocyte antigen (HLA) high-resolution typing ≥ 9/10, or those who have difficulty finding non blood donors due to urgent medical conditions; * No suitable HLA matching haploidentical donor available; * There are suitable unrelated HLA mismatched (HLA high-resolution typing\<9/10) donors; * The subjects or their legal representatives shall sign an informed consent form before the start of the clinical study. Exclusion Criteria: * Patients with severe liver and kidney function (alanine aminotransferase\>2.5 times the upper limit of normal, blood creatinine\>1.5 times the upper limit of normal) and cardiopulmonary dysfunction (New York Heart Association (NYHA) III/IV heart function, ejection fraction\<50%, severe obstructive or restrictive ventilation dysfunction); * Merge active infections; * Eastern Cooperative Oncology Group Performance Status (ECOG) score ≥ 2 points; * Secondary tumors with merged activity; * Severe central nervous system or mental illness leading to the inability to autonomously choose to enter or exit clinical trials; * Combine other allo hematopoietic stem cell transplantation (HSCT) contraindications.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06809712 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Hematologic Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06809712 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06809712 currently recruiting?
Yes, NCT06809712 is actively recruiting participants. Contact the research team at yeyishan@hotmail.com for enrollment information.
Where is the NCT06809712 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT06809712 clinical trial?
NCT06809712 is sponsored by He Huang. The trial plans to enroll 29 participants.