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RECRUITING
NCT04083183
PHASE1/PHASE2

Total Body Irradiation and Astatine-211-Labeled BC8-B10 Monoclonal Antibody for the Treatment of Nonmalignant Diseases

Sponsor: Fred Hutchinson Cancer Center

View on ClinicalTrials.gov

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.

Official title: Targeted Astatine-211-Labeled BC8-B10 Monoclonal Antibody as Reduced Intensity Conditioning for Nonmalignant Diseases

Key Details

Gender

All

Age Range

18 Years - 49 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2020-06-16

Completion Date

2028-01-09

Last Updated

2025-12-18

Healthy Volunteers

No

Interventions

BIOLOGICAL

Astatine At 211 Anti-CD45 Monoclonal Antibody BC8-B10

Given IV

DRUG

Fludarabine

Given IV

DRUG

Cyclophosphamide

Given IV

BIOLOGICAL

Lapine T-Lymphocyte Immune Globulin

Given IV

RADIATION

Total-Body Irradiation

Undergo TBI

PROCEDURE

Hematopoietic Cell Transplantation

Undergo hematopoietic cell transplantation

DRUG

Mycophenolate Mofetil

Given PO or IV

DRUG

Sirolimus

Given PO

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow aspiration

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

Locations (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States