Personalized Immunotherapeutic for Antibiotic-resistant Infection
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|ClinicalTrials.gov Identifier: NCT02508584|
Recruitment Status : Completed
First Posted : July 27, 2015
Last Update Posted : January 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Infection Immune Deficiency Hypogammaglobulinemia Septic Arthritis Mycoplasma Hominis||Biological: anti-mycoplasma hominis antibodies||Early Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Personalized Immunotherapeutic for Antibiotic-resistant Infection|
|Actual Study Start Date :||April 12, 2016|
|Actual Primary Completion Date :||June 12, 2019|
|Actual Study Completion Date :||June 12, 2019|
This is a single patient treatment IND
Biological: anti-mycoplasma hominis antibodies
provision of customized anti-mycoplasma hominis antibodies in the context of a treatment IND.
- Presence or absence of mycoplasma hominis cultured from joint and wound fluid [ Time Frame: from date of initiation of therapy up to 1 year ]see publication below
- Patency of fistula as assessed by clinical exam [ Time Frame: from date of initiation of therapy up to 1 year ]see publication below
- Pain reduction as measured by pain scale and amount of pain medication required [ Time Frame: from date of initiation of therapy up to 1 year ]see publication below
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02508584
|United States, Massachusetts|
|Brigham and Women's Hosptial|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Duane R. Wesemann, MD, PhD||Brigham and Women's Hosptial|