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NOT YET RECRUITING
NCT07576699
PHASE1/PHASE2

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

Sponsor: Cellenkos, Inc.

View on ClinicalTrials.gov

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)

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2026-07-01

Completion Date

2029-06-30

Last Updated

2026-05-11

Healthy Volunteers

No

Interventions

BIOLOGICAL

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

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