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

NCT07576699 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: CK0802-101-1
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief 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)

Conditions

Steroid Refractory Graft Versus Host Disease

Keywords

gvhd; Tregs; graft vs. host disease; steroid refractory; steroid refractory GVHD; CK0802; T regulatory cells; CK0802 Tregs

Outcome Measures

Primary Outcomes (2)

• Phase 1b

  Dose limiting toxicities of CK0802 in SR GVHD as assessed by the incidence and severity of AE and SAEs determined by the NCI-CTCAE Version 6.0.

  Day +29

• Phase 2a

  Overall Response (OR) at day +29. Overall response (OR) will include complete response (CR) and partial response (PR). Response to be determined from the maximum acute GVHD stage and grade in each organ

  D +29

Study Arms (1)

Treatment Arm

EXPERIMENTAL

CK0802 Tregs will be administered intravenously at a fixed dose of 100 million Treg cells.

Biological: CK0802 (Allogeneic, Cryopreserved, Cord blood-derived T-regulatory cells, cells that are not HLA matched)

Interventions

CK0802 (Allogeneic, Cryopreserved, Cord blood-derived T-regulatory cells, cells that are not HLA matched) BIOLOGICAL

Subjects will receive seven planned doses of CK0802 on study day +1, +3 (+/-1 day), +5 (+/-1 day), +7 (+/- 2 day), +14 (+/- 3 days), +21 (+/-3 days) and +28 (+/-3 days). A total of 7 doses will be administered. If Day 29 assessment shows PR or MR, then 4 additional weekly infusion of CK0802 Tregs can be administered (study days: 35 (+/- 2 day), 42 (+/- 2 day), 49 (+/- 2 day), and 55(+/- 2 day)), for a total of 11 infusions

Treatment Arm

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age ≥12 years old (first 3 subjects will be ≥ 18 years)
• \. Grade 2-4 acute GVHD (aGVHD) at baseline
• \. No other prior aGVHD treatment
• \. 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
• \. Female subjects of childbearing potential (FPCP) must have a negative urine or serum pregnancy test.
• \. Agreed to abide by all protocol required procedures including study-related assessments, visits and long term follow up.
• \. Willing and able to provide written informed consent.
• \. Signed informed consent

You may not qualify if:

• \. 30 days prior treatment with any other investigational agent after allogeneic HSCT.
• \. Known HIV seropositivity.
• \. Uncontrolled infection, not responding to appropriate antimicrobial agents after seven days of therapy. The Protocol PI is the final arbiter of eligibility.
• \. 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.
• \. Subjects who are pregnant or breastfeeding.

Sponsors & Collaborators

• Cellenkos, Inc.: lead

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MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Cryopreservation

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Tissue Preservation; Histocytological Preparation Techniques; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Preservation, Biological; Therapeutics; Investigative Techniques

Central Study Contacts

Clinical Trial Specialist

CONTACT

8002178247; contact@cellenkosinc.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multiple doses of CK0802 will be administered intravenously over approximately a month

Study Record Dates

• First Submitted: May 1, 2026
• First Posted: May 8, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share