Actively Recruiting
BPC2001 for the Prevention of Acute Graft-Versus-Host Disease Following Haploidentical Stem Cell Transplantation
Led by BioPhoenix Co., Ltd. · Updated on 2025-11-24
50
Participants Needed
1
Research Sites
121 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Phase IIb open label study evaluates the safety and efficacy of repeat doses of BPC2001 in combination with standard of care treatment for the prevention of acute graft-vs-host-disease (aGvHD) in subjects following Haploidentical Stem Cell Transplantation (Haplo-SCT).
CONDITIONS
Official Title
BPC2001 for the Prevention of Acute Graft-Versus-Host Disease Following Haploidentical Stem Cell Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 65 years
- Able to understand and voluntarily sign the informed consent form
- Diagnosed with a hematologic malignancy and candidate for haploidentical stem cell transplant (acute leukemia in remission, myelodysplastic syndrome, chronic myelomonocytic leukemia, or myeloproliferative neoplasm with <10% bone marrow blasts)
- Adequate organ function for transplantation: cardiac ejection fraction ≥45%, total bilirubin <1.5× upper limit of normal (ULN) unless Gilbert's syndrome or malignancy involvement, ALT and AST <2.5× ULN, serum creatinine <2 mg/dL or creatinine clearance >50 mL/min, lung function tests (DLCO and/or FEV1) ≥50%
- Suitable for myeloablative haplotype-related donor transplant
- Suitable for first allogeneic hematopoietic stem cell transplant
- Transplant donor aged >30 years or if ≤30 years, donor must be female for male subject
- Donor must have at least 5/10 HLA match by high-resolution typing
- Donor meets criteria for peripheral blood stem cell donation
- Donor's specific antibodies are negative (<2,000 MFI)
- Using peripheral blood stem cells mobilized by G-CSF (bone marrow or cord blood not allowed)
- Karnofsky Performance Status score ≥60
- Candidate for anti-GvHD prophylaxis including ATG, calcineurin inhibitor with MTX and MMF
- Female subjects of childbearing potential must have negative pregnancy test and use double barrier contraception through 90 days after last investigational drug dose
- Male subjects must agree to use effective contraception through 90 days after last investigational drug dose
You will not qualify if you...
- Prior organ transplantation
- Planned use of GvHD prophylaxis drugs other than those listed in inclusion criteria
- Received investigational drug within 4 half-lives or 14 days before transplant or plans to participate in another clinical study before completing evaluations
- Uncontrolled malignancies other than hematologic malignancy
- Active central nervous system disease
- Uncontrolled active bacterial, viral, or fungal infections
- Known HIV infection or positive HIV antibody test
- Positive hepatitis B surface antigen or core antibody with detectable HBV DNA, positive hepatitis C antibody with detectable HCV RNA, or positive syphilis TRUST test
- Pregnant or breastfeeding females
- Major surgery within 1 month before first investigational drug dose
- Other medical conditions making participation unsuitable
- History of uncontrolled autoimmune disease or on active treatment
- Vaccinated with live or attenuated vaccine within 4 weeks before first investigational drug dose
- History of recent serious heart conditions within 6 months
- Planned prophylactic donor lymphocyte infusion therapy
- Transplant donor is the subject's mother or collateral relative
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
Research Team
N
Nicole Shih, MSC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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