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

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

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

This clinical trial will be conducted in two parts where the first part of Phase 1b will determine the safety and tolerability of CK0802 in patients with steroid refractory GVHD and the second part of Phase 2a will examine the preliminary efficacy of CK0802 in patients with steroid refractory GVHD

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.