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NCT07499102
CK0801 for Treatment of Aplastic Anemia
Phase 2 trial testing CK0801 in Aplastic Anemia in 12 participants. Not yet recruiting.
3 August 2028
Quick facts
| Lead sponsor | Cellenkos, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 12 |
| Start date | 3 August 2026 |
| Primary completion | 3 August 2028 |
| Estimated completion | 3 August 2029 |
Drugs / interventions tested
- CK0801 — full drug profile →
Conditions studied
- Aplastic Anemia — all drugs for Aplastic Anemia →
Sponsor
Cellenkos, Inc. — full company profile →
Who can join
18 and older, any sex, with Aplastic Anemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07499102
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of CK0801
Trials testing the same drug.
- NCT03773393 — A Clinical Trial of CK0801 (a New Drug) in Patients With Bone Marrow Failure Syndrome (BMF) · Phase 1 · active not recruiting
Other recruiting trials for Aplastic Anemia
Currently open trials in the same condition.
- NCT07101770 — A Prediction Model in Pregnant Women With Aplastic Anemia · recruiting
- NCT06752694 — Ruxolitinib Based GVHD Prophylaxis Regimen Before, During, and After Hematopoietic Cell Transplantation in Older Adult P · Phase 2 · recruiting
- NCT06936930 — Reproductive and Mental Health of Patients With Aplastic Anemia · recruiting
- NCT06689800 — Let's Get REAL: Family Health Communication Tool in Pediatric Stem Cell Transplant and Cellular Therapy · NA · recruiting
- NCT06613880 — Standard Immunosuppressive Therapy Combined With Romiplostim N01 as First-line Treatment for Severe Aplastic Anemia · Phase 2 · recruiting
Other Cellenkos, Inc. trials
Trials by the same sponsor.
- NCT05423691 — Leading in MPNs Beyond Ruxolitinib in Combo With T-Regs · Phase 1 · recruiting
- NCT04468971 — REgulatory T Cell infuSion fOr Lung Injury Due to COVID-19 PnEumonia · Phase 1 · completed
- NCT03773393 — A Clinical Trial of CK0801 (a New Drug) in Patients With Bone Marrow Failure Syndrome (BMF) · Phase 1 · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07499102 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Cellenkos, Inc.
- Last refreshed: 3 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07499102.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing