A Phase Ib/IIa multicentric study to determine the safety and efficacy of a combination of anti-CD3 & anti-CD7 ricin A immunotoxins (T-Guard) for the treatment of steroid-resistant acute Graft-versus-Host Disease. - T-Guard for acute GVHD

Xenikos BV0 sites20 target enrollmentNovember 25, 2013

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Acute Graft-versus-Host Disease (GVHD) not responding on regular first line therapy of 2 mg/kg corticosteroids daily.
Sponsor: Xenikos BV
Enrollment: 20
Status: Active, not recruiting
Last Updated: 8 years ago

No summary available.

Registry

who.int

Start Date

November 25, 2013

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•\- Patients suffering from acute GVHD which is staged as Grade II\-IV (Appendix 1\) according to the modified Glucksberg Criteria and progressing after 3 days, or not improving after 7 days, of methylprednisolone at a dose of 2 mg/kg per day.
•\- Age \= 18 years.
•\- Patients or an impartial witness (in case the patient is capable to provide verbal consent but not capable to sign the informed consent) should have given written informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 16
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range 4

•\- Patients receiving concomitant investigational therapeutics for acute GVHD, including investigational agents used for GVHD prophylaxis, at the time of enrollment.
•\- Patients with signs or symptoms suggestive of chronic GVHD.
•\- Patients requiring mechanical ventilation, requiring vasopressor support, requiring hemodialysis, having serum creatinine \> 266 µmol/l (\> 3mg/dl), or having a serum albumin level of 15 g/l or less.
•\- Patients having uncontrolled infections.
•\- Patients with current signs or symptoms of active intrapulmonary disease.
•\- Patients with known hypersensitivity to any of the components of the study drug (murine mAb or RTA).
•\- Female patients who are pregnant, breast feeding, or, if sexually active, unwilling to use effective birth control for the duration of the study.
•\- Male patients who are, if sexually active, unwilling to use effective birth control for 30 days after the last infusion.
•\- Patients participating in a clinical trial with another investigational medicinal product within 30 days prior to providing informed consent.
•\- Patients whose decision to participate might be unduly influenced by perceived expectation of gain or harm by participation, such as patients in detention due to official or legal order.