A Phase I/II study to determine the safety and efficacy of a combination of anti-CD3 & anti-CD7 ricin A immunotoxins (T-Guard) for treating steroid-resistant acute graft-versus-host disease.
Phase 2
Completed
- Conditions
- Immuunsysteemaandoeningen: acute omgekeerde afstotingsziekteacute graft-versus-host diseaseGVHD
- Registration Number
- NL-OMON44132
- Lead Sponsor
- Xenikos BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
Inclusion Criteria
Patients suffering from severe acute GVHD (Grade II-IV) that is progressing after 3 days, or nonimproving after 7 days, of prednisolone at 2 mg/kg a day.
Exclusion Criteria
Patients receiving concomitant investigational therapeutics for acute GVHD, including agents used
for GVHD prophylaxis, at the time of enrollment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>PRIMARY<br /><br><br /><br>* The acute GVHD response rate on study Day 28.</p><br>
- Secondary Outcome Measures
Name Time Method