Personalized Immunotherapeutic for Antibiotic-resistant Infection

NCT ID: NCT02508584

Last Updated: 2020-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-12
• Study Completion Date: 2019-06-12

Brief Summary

M. A. suffers from hypogammaglobulinemia that has been complicated by refractory Mycoplasma hominis septic arthritis. He has been receiving the antibiotic valnemulin under Emergency Investigational New Drug (eIND) 114686 following many prior treatments with standard antibiotics. M.A. has also been receiving intravenous immunoglobulin (IVIG) replacement. The antibiotic and IVIG have been helpful, but not sufficient for cure. Antibodies have been shown to be critical for defense against mycoplasma. Hyperimmune serum against mycoplasma isolated from rabbit or goat has been effective in cases of chronic erosive arthritis in the setting of immune deficiency, and in some cases resulted in cures. The investigators propose to use M. hominis isolated from M. A. to vaccinate one transgenic cow (developed by SAB Biotherapeutics), purify human antibody after vaccination, test the purified antibody in killing assays to confirm potency, and then administer the purified human IgG to M. A. after FDA compassionate use IND application and local Institutional Review Board (IRB) approval.

Detailed Description

M. A. suffers from hypogammaglobulinemia that has been complicated by refractory Mycoplasma hominis septic arthritis. He has been receiving the antibiotic valnemulin under Emergency Investigational New Drug (eIND) 114686 following many prior treatments with standard antibiotics. M.A. has also been receiving intravenous immunoglobulin (IVIG) replacement. The antibiotic and IVIG have been helpful, but not sufficient for cure.

Antibodies have been shown to be critical for defense against mycoplasma. Hyperimmune serum against mycoplasma isolated from rabbit or goat has been effective in cases of chronic erosive arthritis in the setting of immune deficiency, and in some cases resulted in cures.

SAB Biotherapeutics, Inc. (formerly Sanford Applied Biosciences, LLC) located in Sioux Falls, SD, have developed transchromosomic (Tc) cows containing human immunoglobulin (Ig) heavy (IgH) and light (IgL) chain loci in the setting of inactivated bovine IgH and Ig lambda loci. To date, SAB Biotherapeutics (SAB) has several products in development that have been tested in animal models, but to date no human trials.

Investigators propose to use M. hominis isolated from M. A. to vaccinate one transgenic cow, purify antibody after vaccination, test the purified antibody in killing assays to confirm potency, and then administer the purified human IgG to M. A. after FDA compassionate use IND application and local Institutional Review Board (IRB) approval.

M. A. is a highly educated person with full decision making capacity and is well aware of the uncertainties and risks associated with this treatment. This proposal is designed to offer this patient an alternative and perhaps curative approach to his disease.

Conditions

Infection; Immune Deficiency; Hypogammaglobulinemia; Septic Arthritis; Mycoplasma Hominis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

This is a single patient treatment IND

Group Type: EXPERIMENTAL

anti-mycoplasma hominis antibodies

Intervention Type: BIOLOGICAL

provision of customized anti-mycoplasma hominis antibodies in the context of a treatment IND.

Interventions

anti-mycoplasma hominis antibodies

provision of customized anti-mycoplasma hominis antibodies in the context of a treatment IND.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Adult with decision making capacity afflicted with chronic mycoplasma hominis septic arthritis despite standard treatments.

Exclusion Criteria

• None

• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Duane Robert Wesemann

Associate Physician and Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Duane R. Wesemann, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hosptial

Locations

Brigham and Women's Hosptial

Boston, Massachusetts, United States

Countries

United States

References

Silver JN, Ashbaugh CD, Miles JJ, Wu H, Marecki GT, Hwang JK, Jiao JA, Abrams M, Sullivan EJ, Wesemann DR. Deployment of Transchromosomal Bovine for Personalized Antimicrobial Therapy. Clin Infect Dis. 2018 Mar 19;66(7):1116-1119. doi: 10.1093/cid/cix977.

Reference Type: RESULT

PMID: 29272362 (View on PubMed)

Other Identifiers

2015P001027

Identifier Type: -

Identifier Source: org_study_id