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Not yet recruiting NCT07576699

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

Phase I / Phase II Interventional Steroid Refractory Graft Versus Host Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CK0802 (Allogeneic, Cryopreserved, Cord blood-derived T-regulatory cells, cells that are not HLA matched).
Who it may be relevant to
Registry conditions: Steroid Refractory Graft Versus Host Disease. Basic parameters: from 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Detailed description

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

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

Primary outcome measures

  • Phase 1b [Time frame: Day +29]
  • Phase 2a [Time frame: D +29]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • WALLACE AB. The exposure treatment of burns. Lancet. 1951 Mar 3;1(6653):501-4. doi: 10.1016/s0140-6736(51)91975-7. No abstract available. PMID 14805109
  • Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials. 1989 Mar;10(1):1-10. doi: 10.1016/0197-2456(89)90015-9. PMID 2702835
  • Levine JE. Prediction and Prognostication of Acute Graft-Versus-Host Disease by MAGIC Biomarkers. Am J Hematol. 2025 May;100 Suppl 3(Suppl 3):5-13. doi: 10.1002/ajh.27594. PMID 40123552
  • Malard F, Huang XJ, Sim JPY. Treatment and unmet needs in steroid-refractory acute graft-versus-host disease. Leukemia. 2020 May;34(5):1229-1240. doi: 10.1038/s41375-020-0804-2. Epub 2020 Apr 3. PMID 32242050
  • Mahat U, Przepiorka D, Fashoyin-Aje LA. Remestemcel-L-rknd for Steroid-Refractory Acute Graft-vs-Host Disease in Pediatric Patients. JAMA. 2025 Jul 1;334(1):81-82. doi: 10.1001/jama.2025.6179. PMID 40397429
  • Shneider NA, Nesta AV, Rifai OM, Yasek J, Elyaman W, Aziz-Zaman S, Lyu MA, Levy SHS, Hoover BN, Vlad G, Huang M, Zeng K, Sadeghi T, Reddy A, Flowers CR, Parmar S. Clinical Safety and Preliminary Efficacy of Regulatory T Cells for ALS. NEJM Evid. 2025 May;4(5):EVIDoa2400249. doi: 10.1056/EVIDoa2400249. Epub 2025 Apr 22. PMID 40261116
  • Gladstone DE, Kim BS, Mooney K, Karaba AH, D'Alessio FR. Regulatory T Cells for Treating Patients With COVID-19 and Acute Respiratory Distress Syndrome: Two Case Reports. Ann Intern Med. 2020 Nov 17;173(10):852-853. doi: 10.7326/L20-0681. Epub 2020 Jul 6. No abstract available. PMID 32628535
  • Kadia TM, Huang M, Pemmaraju N, Abbas HA, Ly C, Masarova L, Yilmaz M, Lyu MA, Zeng K, Sadeghi T, Cook R, DiNardo CD, Daver N, Issa GC, Jabbour E, Borthakur G, Jain N, Garcia-Manero G, Parmar S, Flowers C, Kantarjian H, Verstovsek S. Phase 1 Study of CK0801 in Treatment of Bone Marrow Failure Syndromes. NEJM Evid. 2024 Jun;3(6):EVIDoa2300362. doi: 10.1056/EVIDoa2300362. Epub 2024 May 28. PMID 38804782

Identifiers

NCT: NCT07576699 · CK0802-101-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗