GVHD prophylaxis

Phase 2Biologic

NNational Cancer Institute (NCI)

GVHD prophylaxis is one of 36 biologic programs targeting HIV. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

HIVRecruiting

Allogeneic Hematopoietic Cell TransplantActive, not recruiting

HIVPreclinical

Recruiting

Allogeneic Hematopoietic Cell TransplantPhase 2

Active, not recruiting

Competition

Competitive Landscape

39 competitors in HIV

#DrugCompanyPhaseTrials

Tivicay

GSK

Approved

5 2

Cabenuva

GSK

Approved

3 3

Sustiva

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Approved

6 4

Pifeltro

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Fostemsavir

1 6

Selzentry

GSK

Phase 2

4 7

INCMGA00012

Incyte

Phase 3

1 8

Daraprim

CClinique Sainte Clotilde

Phase 2

2 9

Fosamax

OOrganon and Co

Phase 2

1 10

Topamax

WWim Janssens

Phase 2

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2028

PreclinicalRecruiting

HIV

NCT05470491

Q2 2030

Phase 2Active, not recruiting

Allogeneic Hematopoietic Cell Transplant

NCT03663933

Q4 2030

Phase 2Active, not recruiting

Peripheral T-Cell Lymphoma

NCT03922724

Q4 2036

Phase 2Recruiting

Primary T-Cell Immunodeficiency Disorders

NCT02579967

Clinical

Trials by Indication[1]

Leukemia2 trials

Allogeneic Stem Cell Transplantation Followed By Targeted Immune Therapy In Average Risk Leukemia

Completed·—·Phase 1·NCT01020539·18 enrolled

Pilot Trial of Targeted Immune-Depleting Chemotherapy and Reduced-Intensity Matched Unrelated Double Cord Blood Transplant for the Treatment of Leukemias, Lymphomas, and Pre-Malignant Blood Disorders

Terminated·NNational Cancer Institute (NCI)·Phase 1·NCT00973804·4 enrolled

Transplantation1 trial

Reduced Intensity (RIC) Conditioning And Transplantation of HLA-Haplo-HCT

Completed·MMasonic Cancer Center, University of Minnesota·Phase 2·NCT02988466·78 enrolled

Bone Marrow Transplant1 trial

Bone Marrow Transplant From Partially Matched Donors and Nonmyeloablative Conditioning for Blood Cancers (BMT CTN 0603)

Completed·MMedical College of Wisconsin·Phase 2·NCT00849147·55 enrolled

Myeloid Malignancies1 trial

Post Transplant High-Dose Cy as GvHD Prophylaxis in 1 HLA Mismatched Unrelated HSCT for Myeloid Malignancies

Completed·GGruppo Italiano Trapianto di Midollo Osseo·Phase 2·NCT03270748·78 enrolled

Severe Aplastic Anemia1 trial

Peripheral Blood Allogenic Stem Cell Transplantation Using Non-anti Thymocyte Globulin Regimens in Severe Aplastic Anemia Patients

Unknown status·—·Phase 2/3·NCT03295058·50 enrolled

8 more indications

Conditioning1 trial

Treosulfan-TMI Conditioning and Rapamycin GvHD Prophylaxis Before Allo-HSCT

Terminated·IIRCCS San Raffaele·Phase 1·NCT03963024·9 enrolled

Lymphoma1 trial

Autologous or Donor Stem Cell Transplantation in Treating Patients With Recurrent Non-Hodgkin's Lymphoma (BMT CTN 0202)

Terminated·MMedical College of Wisconsin·Phase 2/3·NCT00096460·30 enrolled

Stem Cell Transplant1 trial

Evaluating the Safety and Effectiveness of an Umbilical Cord Blood Stem Cell Transplant (BMT CTN 0604)

Completed·MMedical College of Wisconsin·Phase 2·NCT00864227·54 enrolled

Myelodysplastic Syndrome1 trial

Peripheral Blood Stem Cell Transplantation From Family Haploidentical Donors in Patients With Myelodysplastic Syndrome and Acute Leukemia Under Primary Prophylaxis With Posaconazole

Completed·CCiceri Fabio·Phase 2·NCT03434704·10 enrolled

Allogeneic Hematopoietic Cell Transplant1 trial

Allogeneic Hematopoietic Cell Transplantation for Disorders of T-cell Proliferation and/or Dysregulation

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT03663933·71 enrolled

HIV1 trial

A Phase I/II Trial of Allogeneic Reduced-Intensity, HLA-Haploidentical Allogeneic Hematopoietic Cell Transplantation Followed by GVHD Prophylaxis With Cyclophosphamide, Bortezomib and Maraviroc for Hematologic Malignancies in People Living With HIV (PLWH)

Recruiting·NNational Cancer Institute (NCI)·Preclinical·NCT05470491·265 enrolled

Primary T-cell Immunodeficiency Disorders1 trial

Pilot Trial of Allogeneic Blood or Marrow Transplantation for Primary Immunodeficiencies

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT02579967·354 enrolled

Peripheral T-Cell Lymphoma1 trial

Phase II Trial of Allogeneic Hematopoietic Cell Transplantation for Peripheral T Cell Lymphoma

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT03922724·118 enrolled

Sources

References

[1]
ClinicalTrials.gov — 14 trial records for GVHD prophylaxis. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — GVHD prophylaxis compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for GVHD prophylaxis. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — National Cancer Institute (NCI) company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Biologic[2]
Highest Phase: Phase 2[1]
Company: NNational Cancer Institute (NCI)

GVHD prophylaxis

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2028

Q2 2030

Q4 2030

Q4 2036

Trials by Indication[1]

Leukemia2 trials

Transplantation1 trial

Bone Marrow Transplant1 trial

Myeloid Malignancies1 trial

Severe Aplastic Anemia1 trial

Conditioning1 trial

Lymphoma1 trial

Stem Cell Transplant1 trial

Myelodysplastic Syndrome1 trial

Allogeneic Hematopoietic Cell Transplant1 trial

HIV1 trial

Primary T-cell Immunodeficiency Disorders1 trial

Peripheral T-Cell Lymphoma1 trial

References

Drug Info

Quick Facts

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