Clinical trial NCT04083183: Total Body Irradiation and Astatine-211-Labeled BC8-B10 Monoclonal Antibody for the Treatment of Nonmalignant Diseases
Official title: Targeted Astatine-211-Labeled BC8-B10 Monoclonal Antibody as Reduced Intensity Conditioning for Nonmalignant Diseases
Conditions: Non-Malignant Neoplasm
Summary: This phase I/II trial studies the best dose of total body irradiation with astatine-211 BC8-B10 monoclonal antibody for the treatment of patients with nonmalignant diseases undergoing hematopoietic cell transplant. Radiation therapy uses high energy gamma rays to kill cancer cells and shrink tumors. Astatine-211-labeled BC8-B10 monoclonal antibody is a monoclonal antibody, called anti-CD45 monoclonal antibody BC8-B10, linked to a radioactive/toxic agent called astatine 211. Anti-CD45 monoclonal antibody BC8-B10 is attached to CD45 antigen positive cancer cells in a targeted way and delivers astatine 211 to kill them. Giving astatine-211 BC8-B10 monoclonal antibody and total-body irradiation before a donor stem cell transplant may help stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells.
Interventions:
description: Given IV
name: Astatine At 211 Anti-CD45 Monoclonal Antibody BC8-B10
other_name: APAMISTAMAB-B10-ASTATINE AT-211
Astatine 211-Labeled Anti-CD45 Monoclonal Antibody BC8-B10
Astatine At 211 MAb BC8-B10
At 211 Anti-CD45 Monoclonal Antibody BC8-B10
At 211 MAb BC8-B10
type: Biological
description: Given IV
name: Fludarabine
other_name: 2-Fluoro-9-beta-arabinofuranosyladenine
2-Fluorovidarabine
2-Fluorovidarabine, 21679-14-1
21679-14-1
9-Beta-D-arabinofuranosyl-2-fluoro-9H-purin-6-amine
9-Beta-D-arabinofuranosyl-2-fluoroadenine
Fluradosa
type: Drug
description: Given IV
name: Cyclophosphamide
other_name: CP monohydrate
CTX
Carloxan
Ciclofosfamida
Ciclofosfamide
Cicloxal
Clafen
Claphene
Cycloblastin
Cycloblastine
Cyclophospham
Cyclophosphamid monohydrate
Cyclophosphamide Monohydrate
Cyclophosphamidum
Cyclophosphan
Cyclophosphane
Cyclostin
Cyclostine
Cytoxan
WR-138719
type: Drug
description: Given IV
name: Lapine T-Lymphocyte Immune Globulin
other_name: Anti-thymocyte Globulin Rabbit
Grafalon
Rabbit ATG
Rabbit Anti-Human Thymocyte Globulin (RATG)
Rabbit Anti-Thymocyte Globulin
Rabbit Antithymocyte Globulin
Thymoglobulin
rATG
type: Biological
description: Undergo TBI
name: Total-Body Irradiation
other_name: SCT_TBI
TBI
TOTAL BODY IRRADIATION
Whole Body Irradiation
Whole-Body Irradiation
type: Radiation
description: Undergo hematopoietic cell transplantation
name: Hematopoietic Cell Transplantation
other_name: HCT
HSCT
Hematopoietic Stem Cell Transplantation
Stem Cell Transplant
type: Procedure
description: Given PO or IV
name: Mycophenolate Mofetil
other_name: 115007-34-6
Cellcept
MMF
type: Drug
description: Given PO
name: Sirolimus
other_name: RAPA
Rapamune
Rapamycin
SILA 9268A
WY-090217
type: Drug
description: Undergo bone marrow aspiration
name: Bone Marrow Aspiration
type: Procedure
description: Undergo blood sample collection
name: Biospecimen Collection
type: Procedure
Study arms:
design_group_description: Patients receive astatine At 211 anti-CD45 monoclonal antibody BC8-B10 IV on any day between days -10 and -7, fludarabine IV on days -6 to -2, cyclophosphamide IV over 1 hour on days -6 to -5 and 3 to 4, and thymoglobulin IV over 4-6 hours on days -4 to -2. Patients undergo TBI on day -1 and hematopoietic cell transplant on day 0. Beginning day 5, patients also receive mycophenolate mofetil PO or IV thrice daily every 8 hours up to day 35 if no GVHD present and sirolimus PO daily until day 365. Patients undergo blood sample collection and may undergo bone marrow aspiration throughout the study.
design_group_title: Treatment (astatine 211,fludarabine,cyclophosphamide,TBI,HCT)
design_group_type: Experimental
Sponsor: Fred Hutchinson Cancer Research Center
Collaborators: National Heart, Lung & Blood Institute
Drug name mappings:
name: 磷酸氟达拉滨
lang: CN
name: Fludarabine Phosphate
lang: EN
name: フルダラビンリン酸エステル
lang: JP
name: 环磷酰胺
lang: CN
name: Cyclophosphamide
lang: EN
name: シクロホスファミド水和物
lang: JP
name: 西罗莫司
lang: CN
name: Sirolimus
lang: EN
name: シロリムス
lang: JP
name: 吗替麦考酚酯
lang: CN
name: Mycophenolate Mofetil
lang: EN
name: ミコフェノール酸 モフェチル
lang: JP
name: At 211 MAb BC8-B10
lang: EN