BPC2001 for the Prevention of Acute Graft-Versus-Host Disease Following Haploidentical Stem Cell Transplantation
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBioPhoenix Co., Ltd.
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
BPC-2001
DrugSubjects will receive 6 weekly doses of BPC2001, 100 μg/kg via IV administration after completion of Haplo-SCT.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Safety run-in and ExpansionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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)
Time frame
Day 100 after the last infusion of stem cell2
AE of BPC2001 in addition to the graft-versus-host disease (GvHD) prophylaxis regimen
Incidence, nature, and severity of treatment-emergent adverse events (AEs)
Time frame
1 year post-transplant3
SAE of BPC2001 in addition to the graft-versus-host disease (GvHD) prophylaxis regimen
Incidence, nature, and severity of serious adverse events (SAEs)
Time frame
1 year post-transplant4
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)
Time frame
1 year post-transplantSecondary outcomes
1
Grades II-IV aGVHD
Acute GVHD will be graded and assessed within 180 days post-transplant
Time frame
Day 180 post-transplant2
Total and moderate-severe cGvHD
Incidence of total and moderate-severe cGvHD assessment
Time frame
Day 180 and 1 year post-transplant3
Non-relapse Mortality (NRM) Rates
The probability of mortality not preceded by relapse of the underlying malignancy will be estimated
Time frame
Day 100, Day 180 and 1 year post-transplant4
Disease-free Survival (DFS)
The probability of survival without relapse of the underlying malignancy will be estimated
Time frame
Day 180 and 1 year post-transplantSponsors and contacts
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Source ClinicalTrials.gov