Clinical trial Recruiting at 1 site Phase1; Phase2 Interventional Ages 18 to 49

Using total body irradiation and a special antibody to treat nonmalignant diseases

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

Run by Fred Hutchinson Cancer Center · NCT04083183 · Data updated 2026-11-12

This study is testing a new treatment using total body radiation and a special antibody to help patients with nonmalignant diseases who are getting a stem cell transplant.

More Malignant Solid Neoplasm trials

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Ages18 Years to 49 Years
SexAll
Enrollment40 (estimated)
SponsorFred Hutchinson Cancer Center
Academic / other
Drugs / interventionsRadiation, cyclophosphamide, fludarabine
Locations1 site (Seattle, Washington)
StatusRecruiting
StartedJune 16, 2020
Main results expectedJanuary 9, 2028
Study endsJanuary 9, 2028
Registry record updatedJune 17, 2026
Trial IDNCT04083183 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 to 50 with nonmalignant diseases that can be treated with allogeneic hematopoietic cell transplantation.

Probably not a fit

Patients with malignant diseases or those outside the specified age range may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase I/II trial investigates the optimal dose of total body irradiation combined with astatine-211-labeled BC8-B10 monoclonal antibody for patients with nonmalignant diseases undergoing hematopoietic cell transplantation. The approach involves administering the monoclonal antibody, which targets CD45 positive cells, along with chemotherapy and total body irradiation to prepare the patient for a donor stem cell transplant. The goal is to eliminate abnormal cells and prevent the immune system from rejecting the donor cells. Patients will be monitored for up to five years post-treatment to assess outcomes and safety.

Why it matters

Potential benefit: If successful, this treatment could improve outcomes for patients with nonmalignant diseases requiring stem cell transplants.

How similar studies have gone: Other studies have shown promise with similar approaches, but this specific combination of treatments is novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Age \>= 18 years and \< 50 years
* Nonmalignant disease treatable by allogeneic hematopoietic cell transplantation (HCT). Patients with a nonmalignant disease that is not clearly defined must be approved by the principal investigator (PI)
* Karnofsky score \>= 70
* Patients must have normal elastography
* If ferritin is elevated, patient must have less than 7 mg/g liver iron concentration on liver T2 magnetic resonance imaging (MRI)
* Patients should have an official gastrointestinal (GI) consult prior to the transplant for full evaluation
* DONOR INCLUSION
* HLA matched related donor that is genotypically or phenotypically identical for HLA-A, -B, -C, -DRB1, -DQB1. Phenotypic identity must be confirmed by high-resolution typing. Sibling donors are preferred over other relationships
* Unrelated donor.

  * Matched for HLA-A, -B, -C, -DRB1, and DQB1 by high-resolution typing; OR
  * Mismatched for a single HLA-class 1 allele or HLA-DQB1 antigen or allele by high-resolution typing.

Note: A donor homozygous for one allele only at HLA-A, B, C, DRB1, or DQB1 is allowed (1 antigen mismatch for graft versus host disease \[GVHD\], 0 antigen mismatch for graft-rejection). In the case of a recipient who is homozygous at one locus, the mismatch is not allowed to be at that locus (0 antigen mismatch for GVHD, 1 antigen mismatch for graft-rejection)

* HLA haploidentical donor. There must be one shared HLA-haplotype based on inheritance. The noninherited haplotype is allowed to be mismatched at any or all of these loci: HLA-A, B, C, DRB1 or DQB1.
* Donor selection guideline recommendations: in the case where there are multiple donor options, donors should be selected based on the following priority numbered below:

  * Related donor genotypically HLA-matched
  * Related donor phenotypically HLA-matched
  * Unrelated donor HLA-matched
  * Unrelated donor with single allele level mismatch at class 1 (HLA-A, -B, or -C). For example, HLA-A02:01 versus HLA-A 02:02
  * Unrelated donor with single allele level mismatch at DQB1
  * HLA-haploidentical donor Note: We require that the donor testing be performed by a United States Clinical Laboratory Improvement Amendment (CLIA) approved laboratory. In the very rare case where the donor testing is not able to be performed in a CLIA approved laboratory, or there is confirmatory testing that needs to be performed, or for any donor identified from Europe and at risk for Creutzfeldt-Jakob Disease (CJD), we note this on the donor screening form and require that the unrelated donor medical director or the attending physician approves the use of the donor HPC-A product under urgent medical need

Exclusion Criteria:

* Patients with Fanconi Anemia
* Impaired cardiac function as evidenced by ejection fraction \< 35% (or, if unable to obtain ejection fraction, shortening fraction of \< 26%) or cardiac insufficiency requiring treatment or symptomatic coronary artery disease. Patients with a shortening fraction of \< 26% may be enrolled if approved by a cardiologist. In addition, patients with poorly controlled hypertension on multiple anti-hypertensive medications, symptomatic coronary artery disease, or patients on cardiac medications for antiarrhythmic or inotropic effects are excluded
* Impaired pulmonary function as evidenced by carbon monoxide diffusing capability test (DLCO) \< 35% of predicted or receiving supplemental continuous oxygen. In addition, if patients are unable to perform pulmonary function tests, then O2 saturation \< 92% on room air
* Impaired renal function as evidenced by estimated creatinine clearance less than 50 ml/min or serum creatinine \> 2 x upper normal limit or dialysis-dependent. Serum creatinine value must be within 28 days prior to start of conditioning

  \* The creatinine clearance may be estimated by the Cockcroft-Gault formula
* Impaired liver function as evidenced by abnormal hepatic function within 2 months prior to the astatine-211 infusion date defined as a total bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) \> 2 times the upper limit of normal (with the exception of elevated total bilirubin level, predominantly indirect bilirubin, in patients with hemoglobinopathy due to acute and/or chronic hemolysis). In addition, patients with the following liver abnormalities are excluded: fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension, alcoholic hepatitis, esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic dysfunction as evidenced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis, or symptomatic biliary disease
* An uncontrolled infection requiring deferral of conditioning as recommended by an infectious disease specialist. A viral upper respiratory tract infection does not constitute an uncontrolled infection in this context
* Patients who are known to be positive for HIV (human immunodeficiency virus)
* Women of childbearing potential who are pregnant or breast-feeding
* Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment
* Allergy to murine-based monoclonal antibodies
* Known contraindication to radiotherapy
* DONOR EXCLUSION
* Donors are excluded when preexisting immunoreactivity is identified that would jeopardize donor hematopoietic cell engraftment. The recommended procedure for patients with 10 of 10 HLA allele level (phenotypic) match is to obtain panel reactive antibody (PRA) screens to class I and class II antigens for all patients before hematopoietic cell transplantation (HCT). If the PRA shows \> 10% activity, then flow cytometric or B and T cell cytotoxic cross matches should be obtained. The donor should be excluded if any of the cytotoxic cross match assays are positive. For those patients with an HLA class I allele or class II allele or antigen mismatch or haploidentical donors, flow cytometric or B and T cell cytotoxic cross matches should be obtained regardless of the PRA results. A positive anti-donor cytotoxic crossmatch is an absolute donor exclusion

Where it's running

  • Fred Hutch/University of Washington Cancer Consortium
    Seattle, Washington, United States
    Recruiting

Study contacts

  • Principal investigator: Phuong Vo — Fred Hutch/University of Washington Cancer Consortium
  • Study coordinator: Phuong Vo
  • Email: ptvo@fredhutch.org
  • Phone: 206-667-2749

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.