CK0802 for Treatment of Steroid Refractory Graft vs. Host Disease (GVHD) (NCT07576699) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
CK0802 for Treatment of Steroid Refractory Graft vs. Host Disease (GVHD)
12 participantsStarted 2026-07-01
Plain-language summary
The purpose of this study is to determine the efficacy and safety of CK0802 Tregs for treatment of refractory GVHD (graft-versus-host disease)
Who can participate
Age range12 Years
SexALL
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Inclusion Criteria:
* 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
* Progressed after 3 days of treatment with 2 mg/kg methylprednisolone (MPE)
* No improvement after 7 days of treatment with 2 mg/kg MPE
* Progressed to a new organ after treatment with 1 mg/kg MPE for skin or upper gastrointestinal (UGI) aGVHD
* Progressed from nadir during or after a steroid taper
* 5\. Female subjects of childbearing potential (FPCP) must have a negative urine or serum pregnancy test.
* 6\. Agreed to abide by all protocol required procedures including study-related assessments, visits and long term follow up.
* 7\. Willing and able to provide written informed consent.
* 8\. Signed informed consent
Exclusion Criteria:
* 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.
* 5\. Subjects who are pregnant or breastfeeding.