BPC2001 for the Prevention of Acute Graft-Versus-Host Disease Following Haploidentical Stem Cell Transplantation

Inclusion Criteria:

1. Male or female ages ≥18 and ≤ 65 years.

2. Before the start of the trial, the subject or his/her guardian is sufficient tounderstand and voluntarily sign the written informed consent form (ICF).

3. Subjects have a hematologic malignancy as defined below and are consideredcandidates for haplo-SCT:

4. Acute leukemia with morphologic complete remission (acute myelogenous leukemia [AML] or acute lymphoblastic leukemia [ALL]);

5. Myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML), ormyeloproliferative neoplasm (MPN) with < 10% blasts in the bone marrow.

6. Organ function tolerated for transplantation:

7. Cardiac function: Left ventricular ejection fraction at rest ≥ 45%;

8. Liver function: Total bilirubin < 1.5 × upper limit of normal (ULN); alanineaminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 × ULN.Subjects who have been diagnosed with Gilbert's syndrome or malignant diseaseinvolvement are allowed to have a total bilirubin value > 1.5 × ULN;

9. Serum creatine < 2 mg/dL or estimated creatinine clearance > 50 mL/mincalculated using the Cockcroft-Gault equation；

10. Pulmonary function tests (PFTs): diffusing capacity of the lung for carbonmonoxide (DLCO) (corrected for hemoglobin) and/or forced expiratory volume in 1second (FEV1) ≥ 50%.

11. Subject is suitable for myeloablative haplotype related donor transplant.

12. Subject is suitable for receiving first alloHSCT.

13. The transplant donor must meet the following criteria:

14. Donor ages > 30 years; If the donor ages is equal to or less than 30 years, thedonor should be female for male subject;

15. High-resolution typing of human leukocyte antigen (HLA)-A, -B, -C, DR, and DQare matched at least 5/10;

16. Meet the criteria for peripheral blood stem cell (PBSC) donation;

17. Donor's specific antibodies are negative, <2,000 MFI.

18. Source of allografts: using G-CSF as the mobilizing agent to mobilize PBSCtransplant; bone marrow or cord blood is not allowed.

19. Karnofsky Performance Status (KPS) score ≥ 60 points.

20. Is a Candidate for anti-GvHD prophylaxis, including ATG, calcineurin inhibitor (CsAor tacrolimus [FK 506]) in combination with MTX and MMF.

21. Female subjects of childbearing potential must have a negative serum pregnancy testprior to enrollment and must have agreed to use a double barrier method ofcontraception from the time of signing the ICF to 90 days after the last dose ofinvestigational drug.

22. Male subjects must agree to use effective contraception from the time of signing theICF to 90 days after the last dose of investigational drug.

Exclusion Criteria:

Any subjects who meet any of the following criteria will be excluded from study entry:

1. Has had any other prior organ transplantation.

2. Planned use of any additional or alternative drugs for GvHD prophylaxis than listedin the inclusion criteria.

3. Has had received an investigational drug within 4 half-lives or within 14 days priorto HSCT, whichever is longer; or plans to participate in another clinical studyprior to completion of all scheduled evaluations in this clinical study.

4. Has other malignancies that are not controlled.

5. Has evidence of active central nervous system (CNS) disease.

6. Patients with uncontrolled active bacterial, viral, or fungal infections.

7. Known history of human immunodeficiency virus (HIV) or positive HIV antibody test.

8. 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 thelimit of quantification; or hepatitis C virus (HCV) antibody and peripheral HCV RNAare positive; or the syphilis TRUST test is positive.

9. Pregnant or lactating females.

10. Has undergone major surgery within 1 month prior to the first dose ofinvestigational drug.

11. In the opinion of the investigator, the subject has any other medical condition thatrenders the subject unsuitable for participation in the study.

12. Has a history of uncontrolled autoimmune disease or on active treatment.

13. Vaccinated with live or attenuated vaccine within 4 weeks prior to the first dose ofinvestigational drug.

14. History of myocardial infarction, unstable angina, acute coronary syndrome,congestive heart failure (New York Heart Society classification ≥ class Ⅲ), orclinically significant arrhythmia within 6 months prior to receiving theinvestigational drug.

15. Plan to use prophylaxis donor lymphocyte infusion (DLI) therapy.

16. The transplant donor is the subject's mother or collateral relative.