CK0802 for Treatment of Steroid Refractory Graft vs. Host Disease (GVHD)
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age12+
SponsorCellenkos, Inc.
About this trial
The purpose of this study is to determine the efficacy and safety of CK0802 Tregs for treatment of refractory GVHD (graft-versus-host disease)
Eligibility criteria
Qualifiers
1. Age ≥12 years old (first 3 subjects will be ≥ 18 years)
2. Grade 2-4 acute GVHD (aGVHD) at baseline
3. No other prior aGVHD treatment
4. Steroid Refractory
Disqualifiers
1. 30 days prior treatment with any other investigational agent after allogeneic HSCT.
2. Known HIV seropositivity.
3. Uncontrolled infection, not responding to appropriate antimicrobial agents after seven days of therapy. The Protocol PI is the final arbiter of eligibility.
4. Subjects with uncontrolled inter-current illness that in the opinion of the investigator would place the subject at greater risk of severe toxicity and/or impair the activity of CK0802.
Trial design
Treatments tested in this trial
- CK0802 (Allogeneic, Cryopreserved, Cord blood-derived T-regulatory cells, cells that are not HLA matched)
Treatment groups
12 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov