CK0802 for Treatment of Steroid Refractory Graft vs. Host Disease (GVHD)

Starting soon · Phase 1/Phase 2

Conditions studied: Steroid Refractory Graft Versus Host Disease

In brief

The purpose of this study is to determine the efficacy and safety of CK0802 Tregs for treatment of refractory GVHD (graft-versus-host disease)

Key facts

Study ID

NCT07576699

Run by

Cellenkos, Inc.

People needed

12

Starts

2026-07-01

Expected to finish

2029-06-30

Last updated by the study team

2026-05-11

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Full record on ClinicalTrials.gov

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