Graft -Versus-host-diseasePhase 2NCT07246031
BPC2001 for the Prevention of Acute Graft-Versus-Host Disease Following Haploidentical Stem Cell Transplantation
A Phase 2 study testing BPC-2001 in people with Graft -Versus-host-disease and aGVHD, run by BioPhoenix Co., Ltd. at 2 sites in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Graft -Versus-host-disease, aGVHD, Haploidentical Stem Cell Transplantation
- What is being tested?
- BPC-2001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesChina
- Study dates
- 29 Oct 2025to 31 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ages ≥18 and ≤ 65 years.
- Before the start of the trial, the subject or his/her guardian is sufficient to understand and voluntarily sign the written informed consent form (ICF).
- Subjects have a hematologic malignancy as defined below and are considered candidates for haplo-SCT:
- Acute leukemia with morphologic complete remission (acute myelogenous leukemia [AML] or acute lymphoblastic leukemia [ALL]);
- Myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML), or myeloproliferative neoplasm (MPN) with < 10% blasts in the bone marrow.
- Organ function tolerated for transplantation:
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- Cardiac function: Left ventricular ejection fraction at rest ≥ 45%;
- Liver function: Total bilirubin < 1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 × ULN. Subjects who have been diagnosed with Gilbert's syndrome or malignant disease involvement are allowed to have a total bilirubin value > 1.5 × ULN;
- Serum creatine < 2 mg/dL or estimated creatinine clearance > 50 mL/min calculated using the Cockcroft-Gault equation；
- Pulmonary function tests (PFTs): diffusing capacity of the lung for carbon monoxide (DLCO) (corrected for hemoglobin) and/or forced expiratory volume in 1 second (FEV1) ≥ 50%.
- Subject is suitable for myeloablative haplotype related donor transplant.
- Subject is suitable for receiving first alloHSCT.
- The transplant donor must meet the following criteria:
- Donor ages > 30 years; If the donor ages is equal to or less than 30 years, the donor should be female for male subject;
- High-resolution typing of human leukocyte antigen (HLA)-A, -B, -C, DR, and DQ are matched at least 5/10;
- Meet the criteria for peripheral blood stem cell (PBSC) donation;
- Donor's specific antibodies are negative, <2,000 MFI.
- Source of allografts: using G-CSF as the mobilizing agent to mobilize PBSC transplant; bone marrow or cord blood is not allowed.
- Karnofsky Performance Status (KPS) score ≥ 60 points.
- Is a Candidate for anti-GvHD prophylaxis, including ATG, calcineurin inhibitor (CsA or tacrolimus [FK 506]) in combination with MTX and MMF.
- Female subjects of childbearing potential must have a negative serum pregnancy test prior to enrollment and must have agreed to use a double barrier method of contraception from the time of signing the ICF to 90 days after the last dose of investigational drug.
- Male subjects must agree to use effective contraception from the time of signing the ICF to 90 days after the last dose of investigational drug.
Who cannot join
- Any subjects who meet any of the following criteria will be excluded from study entry:
- Has had any other prior organ transplantation.
- Planned use of any additional or alternative drugs for GvHD prophylaxis than listed in the inclusion criteria.
- Has had received an investigational drug within 4 half-lives or within 14 days prior to HSCT, whichever is longer; or plans to participate in another clinical study prior to completion of all scheduled evaluations in this clinical study.
- Has other malignancies that are not controlled.
- Has evidence of active central nervous system (CNS) disease.
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- Patients with uncontrolled active bacterial, viral, or fungal infections.
- Known history of human immunodeficiency virus (HIV) or positive HIV antibody test.
- Hepatitis B virus surface antigen (HBsAg) or hepatitis B virus core antibody (HBcAb) is positive, and the hepatitis B virus (HBV) DNA in peripheral blood is above the limit of quantification; or hepatitis C virus (HCV) antibody and peripheral HCV RNA are positive; or the syphilis TRUST test is positive.
- Pregnant or lactating females.
- Has undergone major surgery within 1 month prior to the first dose of investigational drug.
- In the opinion of the investigator, the subject has any other medical condition that renders the subject unsuitable for participation in the study.
- Has a history of uncontrolled autoimmune disease or on active treatment.
- Vaccinated with live or attenuated vaccine within 4 weeks prior to the first dose of investigational drug.
- History of myocardial infarction, unstable angina, acute coronary syndrome, congestive heart failure (New York Heart Society classification ≥ class Ⅲ), or clinically significant arrhythmia within 6 months prior to receiving the investigational drug.
- Plan to use prophylaxis donor lymphocyte infusion (DLI) therapy.
- The transplant donor is the subject's mother or collateral relative.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Xiaodong Mo, PhD, +86 13810096698, mxd453@163.com
Xiaodong Mo, PhD
- Recruiting
Tongji Medical College of Huazhong University of Science and Technology
Wuhan
Nicole Shih, +886289788901 ext. 103, nicoleshih@biophoenixco.com
Yang Cao, PhD
About this study
Official title: An Open-Label, Single-Arm, Phase Ⅱb Clinical Study of BPC2001 for the Prevention of Acute Graft-Versus-Host Disease Following Haploidentical Stem Cell Transplantation
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).
Read the detailed description
This is an open-label, single center, single-arm study to evaluate six weekly doses of BPC2001 in combination with standard of care treatment (Beijing Protocol) for the prevention of aGvHD in subjects following Haplo-SCT. The study includes a Safety Run-in Phase to assess the safety and tolerability of 30 days DLT after the first dose of BPC2001 followed by an Expansion Phase in which the efficacy of 6 weekly doses of BPC2001 in addition to standard of care for GvHD prophylaxis will be assessed.
- Being tested
- BPC-2001
- Keywords
- aGvHD, Haplo-SCT, BPC2001, BioPhoenix, KRN-7000
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPC-2001Drug
Also called KRN-7000
Subjects will receive 6 weekly doses of BPC2001, 100 μg/kg via IV administration after completion of Haplo-SCT.
| Study group | Role | What they receive |
|---|---|---|
| Safety run-in and Expansion | Experimental | Safety Run-in Phase:
Up to 2 cohorts of at least 3 subjects will be enrolled in the Safety Run-in Phase. The Safety Run in Phase will enroll at least 6 subjects in total. Initially, 3 subjects will be enrolled, treated, and assessed for the dose-limiting toxicity (DLT).
Expansion Phase:
Once a dose/schedule with an acceptable safety/PK profile is determined by the SRC, enrollment will continue to the Expansion Phase. The Expansion Phase will enroll 44 subjects. The dose of BPC2001 will be tentatively 100 μg/kg on a weekly basis for 6 doses, and the specific dose and/or schedule will be determined by the SRC based on the data of the Safety Run-in Phase. Receives: Drug: BPC-2001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grades II-IV aGVHD
To assess the incidence of Grades II-IV aGvHD by Day 100 (D100) after the last infusion of stem cell (the Mount Sinai aGvHD International Consortium [MAGIC] criteria)
Measured: Day 100 after the last infusion of stem cell
AE of BPC2001 in addition to the graft-versus-host disease (GvHD) prophylaxis regimen
Incidence, nature, and severity of treatment-emergent adverse events (AEs)
Measured: 1 year post-transplant
SAE of BPC2001 in addition to the graft-versus-host disease (GvHD) prophylaxis regimen
Incidence, nature, and severity of serious adverse events (SAEs)
Measured: 1 year post-transplant
Lab test values of BPC2001 in addition to the graft-versus-host disease (GvHD) prophylaxis regimen
Incidence, nature, and severity of laboratory test values (complete blood count, serum chemistry test, coagulation test and urinalysis)
Measured: 1 year post-transplant
Vital sign of BPC2001 in addition to the graft-versus-host disease (GvHD) prophylaxis regimen
Incidence, nature, and severity of vital sign measures including temperature, blood pressure (systolic/diastolic), pulse, and respiratory rate
Measured: 1 year post-transplant
Graft failure of BPC2001 in addition to the graft-versus-host disease (GvHD) prophylaxis regimen
Incidence, nature, and severity of graft failure
Measured: 1 year post-transplant
Secondary outcomes (23)
Grades II-IV aGVHD
Acute GVHD will be graded and assessed within 180 days post-transplant
Measured: Day 180 post-transplant
Total and moderate-severe cGvHD
Incidence of total and moderate-severe cGvHD assessment
Measured: Day 180 and 1 year post-transplant
Non-relapse Mortality (NRM) Rates
The probability of mortality not preceded by relapse of the underlying malignancy will be estimated
Measured: Day 100, Day 180 and 1 year post-transplant
Disease-free Survival (DFS)
The probability of survival without relapse of the underlying malignancy will be estimated
Measured: Day 180 and 1 year post-transplant
GvHD-free, Relapse Free Survival (GRFS)
The probability of survival without relapse of the underlying malignancy, without severe (grades 3-4) acute GVHD, and without chronic GVHD requiring systemic immunosuppression will be estimated
Measured: Day 180 and 1 year post-transplant
Overall Survival (OS)
The probability of survival will be estimated
Measured: Day 180 and 1 year post-transplant
PK Profile_Cmax after a single dose of BPC2001
To calculate the PK parameters of the total drug and free drug (if feasible) in the plasma sample, including but not limited to: maximum observed concentration (Cmax) after a single dose
Measured: Day 0 through Day 35
PK Profile_Tmax after a single dose of BPC2001
To calculate the PK parameters of the total drug and free drug (if feasible) in the plasma sample, including but not limited to: time to maximum concentration (Tmax) after a single dose
Measured: Day 0 through Day 35
PK Profile_AUC0-t after a single dose of BPC2001
To calculate the PK parameters of the total drug and free drug (if feasible) in the plasma sample, including but not limited to: area under the concentration versus time curve from time 0 to the time point of the last measurable concentration (AUC0-t) after a single dose
Measured: Day 0 through Day 35
PK Profile_AUC0-inf after a single dose of BPC2001
To calculate the PK parameters of the total drug and free drug (if feasible) in the plasma sample, including but not limited to: area under the concentration versus time curve from time 0 extrapolated to infinite (AUC0-inf) after a single dose
Measured: Day 0 through Day 35
PK Profile_t1/2 after a single dose of BPC2001
To calculate the PK parameters of the total drug and free drug (if feasible) in the plasma sample, including but not limited to: terminal half-life (t1/2) after a single dose
Measured: Day 0 through Day 35
PK Profile_CL after a single dose of BPC2001
To calculate the PK parameters of the total drug and free drug (if feasible) in the plasma sample, including but not limited to: clearance (CL) after a single dose
Measured: Day 0 through Day 35
PK Profile_Vd after a single dose of BPC2001
To calculate the PK parameters of the total drug and free drug (if feasible) in the plasma sample, including but not limited to: volume of distribution (Vd) after a single dose
Measured: Day 0 through Day 35
PK Profile_Cmax after multiple doses of BPC2001
To calculate the PK parameters of the total drug and free drug (if feasible) in the plasma sample, including but not limited to: Cmax after multiple doses
Measured: Day 0 through Day 35
PK Profile_Tmax after multiple doses of BPC2001
To calculate the PK parameters of the total drug and free drug (if feasible) in the plasma sample, including but not limited to: Tmax after multiple doses
Measured: Day 0 through Day 35
PK Profile_AUC0-t after multiple doses of BPC2001
To calculate the PK parameters of the total drug and free drug (if feasible) in the plasma sample, including but not limited to: AUC0-t after multiple doses
Measured: Day 0 through Day 35
PK Profile_AUC0-inf after multiple doses of BPC2001
To calculate the PK parameters of the total drug and free drug (if feasible) in the plasma sample, including but not limited to: AUC0-inf after multiple doses
Measured: Day 0 through Day 35
PK Profile_t1/2 after multiple doses of BPC2001
To calculate the PK parameters of the total drug and free drug (if feasible) in the plasma sample, including but not limited to: t1/2 after multiple doses
Measured: Day 0 through Day 35
PK Profile_Ctrough after multiple doses of BPC2001
To calculate the PK parameters of the total drug and free drug (if feasible) in the plasma sample, including but not limited to: trough concentration (Ctrough) after multiple doses
Measured: Day 0 through Day 35
PK Profile_CLss after multiple doses of BPC2001
To calculate the PK parameters of the total drug and free drug (if feasible) in the plasma sample, including but not limited to: clearance at steady state (CLss) after multiple doses
Measured: Day 0 through Day 35
PK Profile_Vss after multiple doses of BPC2001
To calculate the PK parameters of the total drug and free drug (if feasible) in the plasma sample, including but not limited to: volume of distribution at steady state (Vss) after multiple doses
Measured: Day 0 through Day 35
PK Profile_ARCmax after multiple doses of BPC2001
To calculate the PK parameters of the total drug and free drug (if feasible) in the plasma sample, including but not limited to: accumulation factors ARCmax after multiple doses
Measured: Day 0 through Day 35
PK Profile_ARAUC after multiple doses of BPC2001
To calculate the PK parameters of the total drug and free drug (if feasible) in the plasma sample, including but not limited to: ARAUC after multiple doses
Measured: Day 0 through Day 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start29 Oct 2025
- Primary completion30 Apr 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Graft -Versus-host-diseaseStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioPhoenix Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiaodong Mo, PhD, Study chair, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07246031
- Sponsor's protocol ID
- BPC2001-01
- Status last verified
- Aug 2026
- First submitted
- 22 Sep 2025
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
7.General Office of National Health Commission. Clinical Application Management Standards for Allogeneic Hematopoietic Stem Cell Transplantation Technology (2022 Edition).
Ciurea SO, Al Malki MM, Kongtim P, Fuchs EJ, Luznik L, Huang XJ, Ciceri F, Locatelli F, Aversa F, Castagna L, Bacigalupo A, Martelli M, Blaise D, Ben Soussan P, Arnault Y, Handgretinger R, Roy DC, O'Donnell PV, Bashey A, Solomon S, Romee R, Gayoso J, Lazarus HM, Ballen K, Savani BN, Mohty M, Nagler A. The European Society for Blood and Marrow Transplantation (EBMT) consensus recommendations for donor selection in haploidentical hematopoietic cell transplantation. Bone Marrow Transplant. 2020 Jan;55(1):12-24. doi: 10.1038/s41409-019-0499-z. Epub 2019 Mar 4.
PubMed 30833742Wang Y, Chang YJ, Xu LP, Liu KY, Liu DH, Zhang XH, Chen H, Han W, Chen YH, Wang FR, Wang JZ, Chen Y, Yan CH, Huo MR, Li D, Huang XJ. Who is the best donor for a related HLA haplotype-mismatched transplant? Blood. 2014 Aug 7;124(6):843-50. doi: 10.1182/blood-2014-03-563130. Epub 2014 Jun 10.
PubMed 24916508Duramad O, Laysang A, Li J, Ishii Y, Namikawa R. Pharmacologic expansion of donor-derived, naturally occurring CD4(+)Foxp3(+) regulatory T cells reduces acute graft-versus-host disease lethality without abrogating the graft-versus-leukemia effect in murine models. Biol Blood Marrow Transplant. 2011 Aug;17(8):1154-68. doi: 10.1016/j.bbmt.2010.11.022. Epub 2010 Dec 8.
PubMed 21145405Socie G, Blazar BR. Acute graft-versus-host disease: from the bench to the bedside. Blood. 2009 Nov 12;114(20):4327-36. doi: 10.1182/blood-2009-06-204669. Epub 2009 Aug 27.
PubMed 19713461Hematopoietic Stem Cell Application Group, Chinese Society of Hematology, Chinese Medical Association. [Chinese expert consensus on the diagnosis and treatment of acute graft-versus-host disease after hematopoietic stem cell transplantation (2024)]. Zhonghua Xue Ye Xue Za Zhi. 2024 Jun 14;45(6):525-533. doi: 10.3760/cma.j.cn121090-20240608-00214. Chinese.
PubMed 391344821. Huang Xiaojun. Haploidentical Hematopoietic Stem Cell Transplantation Beijing Protocol, Chinese Journal of Organ Transplantation. 2017;38(2): 65-68.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Arm, Phase Ⅱb Clinical Study of BPC2001 for the Prevention of Acute Graft-Versus-Host Disease Following Haploidentical Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT07246031
- Acronym / sponsor ID
- BPC2001-01
- Keywords
- aGvHD, Haplo-SCT, BPC2001, BioPhoenix, KRN-7000
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- BioPhoenix Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Oct 2025 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 24 Nov 2025 (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.
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).
Detailed description
This is an open-label, single center, single-arm study to evaluate six weekly doses of BPC2001 in combination with standard of care treatment (Beijing Protocol) for the prevention of aGvHD in subjects following Haplo-SCT. The study includes a Safety Run-in Phase to assess the safety and tolerability of 30 days DLT after the first dose of BPC2001 followed by an Expansion Phase in which the efficacy of 6 weekly doses of BPC2001 in addition to standard of care for GvHD prophylaxis will be assessed.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Safety run-in and Expansion | Experimental | Drug: BPC-2001Safety Run-in Phase: Up to 2 cohorts of at least 3 subjects will be enrolled in the Safety Run-in Phase. The Safety Run in Phase will enroll at least 6 subjects in total. Initially, 3 subjects will be enrolled, treated, and assessed for the dose-limiting toxicity (DLT). Expansion Phase: Once a dose/schedule with an acceptable safety/PK profile is determined by the SRC, enrollment will continue to the Expansion Phase. The Expansion Phase will enroll 44 subjects. The dose of BPC2001 will be tentatively 100 μg/kg on a weekly basis for 6 doses, and the specific dose and/or schedule will be determined by the SRC based on the data of the Safety Run-in Phase. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Male or female ages ≥18 and ≤ 65 years.
- Before the start of the trial, the subject or his/her guardian is sufficient to understand and voluntarily sign the written informed consent form (ICF).
- Subjects have a hematologic malignancy as defined below and are considered candidates for haplo-SCT:
- Organ function tolerated for transplantation:
- Subject is suitable for myeloablative haplotype related donor transplant.
Key exclusion criteria (17 listed)
- Has had any other prior organ transplantation.
- Planned use of any additional or alternative drugs for GvHD prophylaxis than listed in the inclusion criteria.
- Has had received an investigational drug within 4 half-lives or within 14 days prior to HSCT, whichever is longer; or plans to participate in another clinical study prior to completion of all scheduled evaluations in this clinical study.
- Has other malignancies that are not controlled.
- Has evidence of active central nervous system (CNS) disease.
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 |
|---|---|---|
| BPC-2001Also: KRN-7000Subjects will receive 6 weekly doses of BPC2001, 100 μg/kg via IV administration after completion of Haplo-SCT. | Drug | Safety run-in and Expansion |
Primary outcome
Grades II-IV aGVHD
Time frame: Day 100 after the last infusion of stem cell
To assess the incidence of Grades II-IV aGvHD by Day 100 (D100) after the last infusion of stem cell (the Mount Sinai aGvHD International Consortium [MAGIC] criteria)
AE of BPC2001 in addition to the graft-versus-host disease (GvHD) prophylaxis regimen
Time frame: 1 year post-transplant
Incidence, nature, and severity of treatment-emergent adverse events (AEs)
SAE of BPC2001 in addition to the graft-versus-host disease (GvHD) prophylaxis regimen
Time frame: 1 year post-transplant
Incidence, nature, and severity of serious adverse events (SAEs)
Lab test values of BPC2001 in addition to the graft-versus-host disease (GvHD) prophylaxis regimen
Time frame: 1 year post-transplant
Incidence, nature, and severity of laboratory test values (complete blood count, serum chemistry test, coagulation test and urinalysis)
Vital sign of BPC2001 in addition to the graft-versus-host disease (GvHD) prophylaxis regimen
Time frame: 1 year post-transplant
Incidence, nature, and severity of vital sign measures including temperature, blood pressure (systolic/diastolic), pulse, and respiratory rate
Graft failure of BPC2001 in addition to the graft-versus-host disease (GvHD) prophylaxis regimen
Time frame: 1 year post-transplant
Incidence, nature, and severity of graft failure
23 secondary outcomes
Grades II-IV aGVHD
Time frame: Day 180 post-transplant
Total and moderate-severe cGvHD
Time frame: Day 180 and 1 year post-transplant
Non-relapse Mortality (NRM) Rates
Time frame: Day 100, Day 180 and 1 year post-transplant
Disease-free Survival (DFS)
Time frame: Day 180 and 1 year post-transplant
GvHD-free, Relapse Free Survival (GRFS)
Time frame: Day 180 and 1 year post-transplant
Overall Survival (OS)
Time frame: Day 180 and 1 year post-transplant
PK Profile_Cmax after a single dose of BPC2001
Time frame: Day 0 through Day 35
PK Profile_Tmax after a single dose of BPC2001
Time frame: Day 0 through Day 35
PK Profile_AUC0-t after a single dose of BPC2001
Time frame: Day 0 through Day 35
PK Profile_AUC0-inf after a single dose of BPC2001
Time frame: Day 0 through Day 35
PK Profile_t1/2 after a single dose of BPC2001
Time frame: Day 0 through Day 35
PK Profile_CL after a single dose of BPC2001
Time frame: Day 0 through Day 35
PK Profile_Vd after a single dose of BPC2001
Time frame: Day 0 through Day 35
PK Profile_Cmax after multiple doses of BPC2001
Time frame: Day 0 through Day 35
PK Profile_Tmax after multiple doses of BPC2001
Time frame: Day 0 through Day 35
PK Profile_AUC0-t after multiple doses of BPC2001
Time frame: Day 0 through Day 35
PK Profile_AUC0-inf after multiple doses of BPC2001
Time frame: Day 0 through Day 35
PK Profile_t1/2 after multiple doses of BPC2001
Time frame: Day 0 through Day 35
PK Profile_Ctrough after multiple doses of BPC2001
Time frame: Day 0 through Day 35
PK Profile_CLss after multiple doses of BPC2001
Time frame: Day 0 through Day 35
PK Profile_Vss after multiple doses of BPC2001
Time frame: Day 0 through Day 35
PK Profile_ARCmax after multiple doses of BPC2001
Time frame: Day 0 through Day 35
PK Profile_ARAUC after multiple doses of BPC2001
Time frame: Day 0 through Day 35
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Background7.General Office of National Health Commission. Clinical Application Management Standards for Allogeneic Hematopoietic Stem Cell Transplantation Technology (2022 Edition).
- Background: PubMed 30833742Ciurea SO, Al Malki MM, Kongtim P, Fuchs EJ, Luznik L, Huang XJ, Ciceri F, Locatelli F, Aversa F, Castagna L, Bacigalupo A, Martelli M, Blaise D, Ben Soussan P, Arnault Y, Handgretinger R, Roy DC, O'Donnell PV, Bashey A, Solomon S, Romee R, Gayoso J, Lazarus HM, Ballen K, Savani BN, Mohty M, Nagler A. The European Society for Blood and Marrow Transplantation (EBMT) consensus recommendations for donor selection in haploidentical hematopoietic cell transplantation. Bone Marrow Transplant. 2020 Jan;55(1):12-24. doi: 10.1038/s41409-019-0499-z. Epub 2019 Mar 4.
- Background: PubMed 24916508Wang Y, Chang YJ, Xu LP, Liu KY, Liu DH, Zhang XH, Chen H, Han W, Chen YH, Wang FR, Wang JZ, Chen Y, Yan CH, Huo MR, Li D, Huang XJ. Who is the best donor for a related HLA haplotype-mismatched transplant? Blood. 2014 Aug 7;124(6):843-50. doi: 10.1182/blood-2014-03-563130. Epub 2014 Jun 10.
- Background: PubMed 21145405Duramad O, Laysang A, Li J, Ishii Y, Namikawa R. Pharmacologic expansion of donor-derived, naturally occurring CD4(+)Foxp3(+) regulatory T cells reduces acute graft-versus-host disease lethality without abrogating the graft-versus-leukemia effect in murine models. Biol Blood Marrow Transplant. 2011 Aug;17(8):1154-68. doi: 10.1016/j.bbmt.2010.11.022. Epub 2010 Dec 8.
- Background: PubMed 19713461Socie G, Blazar BR. Acute graft-versus-host disease: from the bench to the bedside. Blood. 2009 Nov 12;114(20):4327-36. doi: 10.1182/blood-2009-06-204669. Epub 2009 Aug 27.
- Background: PubMed 39134482Hematopoietic Stem Cell Application Group, Chinese Society of Hematology, Chinese Medical Association. [Chinese expert consensus on the diagnosis and treatment of acute graft-versus-host disease after hematopoietic stem cell transplantation (2024)]. Zhonghua Xue Ye Xue Za Zhi. 2024 Jun 14;45(6):525-533. doi: 10.3760/cma.j.cn121090-20240608-00214. Chinese.
- Background1. Huang Xiaojun. Haploidentical Hematopoietic Stem Cell Transplantation Beijing Protocol, Chinese Journal of Organ Transplantation. 2017;38(2): 65-68.
- Individual participant dataSharing planned: No
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Graft-Versus-Host Disease, Graft-versus-leukemia
RecruitingPhase 1/2
The Lowest Effective Dose of Post-Transplantation Cyclophosphamide in Combination With Sirolimus and Mycophenolate Mofetil as Graft-Versus-Host Disease Prophylaxis After Reduced Intensity Conditioning and Peripheral Blood Stem Cell Transplantation
Peripheral Blood Stem Cell Transplantation, Hematopoietic Stem Cell Transplantation
RecruitingPhase 1/2
Phase I/II Study of Pacritinib, A JAK2/IRAK1/CSF1R Inhibitor, in Refractory Chronic Graft-Versus-Host Disease (cGVHD) After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
Graft vs Host Disease
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.
Xiaodong Mo, PhD study chair
Peking University People's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BPC-2001 in people with Graft -Versus-host-disease and aGVHD, run by BioPhoenix Co., Ltd. at 2 sites 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 22 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 phase mean?
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicole Shih, MSC (+886-2-8978 8901 ext. 103, nicoleshih@biophoenixco.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grades II-IV aGVHD (time frame: Day 100 after the last infusion of stem cell). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07246031, which also lists 7 linked publications.
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 17 Aug 2026.