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CK0801 for Treatment of Aplastic Anemia

NCT07499102 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-04-03

No results posted yet for this study

Summary

This Phase 2, multicenter, open-label study is evaluating CK0801 for the treatment of aplastic anemia in adults with persistent transfusion dependence after at least one prior line of therapy or intolerance to standard-of-care treatment. CK0801 is an allogeneic cord blood-derived regulatory T-cell therapy administered intravenously. The study is designed to assess safety and clinical activity, including hematologic response, transfusion independence, duration of response, survival outcomes, and patient-reported outcomes. Exploratory assessments include immune reconstitution, biomarkers, pharmacokinetics, immunogenicity, and donor-specific antibodies. The primary endpoint is overall response at Day 180.

Conditions

  • Aplastic Anemia

Interventions

DRUG

CK0801

CK0801 is an investigational allogeneic, cord blood-derived regulatory T-cell product administered by intravenous infusion. The planned dose is 1 x 10\^7 CK0801 Tregs/kg using actual body weight, capped at 100 kg.

Sponsors & Collaborators

  • Cellenkos, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-03
Primary Completion
2028-08-03
Completion
2029-08-03
FDA Drug
Yes

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07499102 on ClinicalTrials.gov