Table 3. Treg-cell immunotherapy trials... | American Society of Hematology

Table 3.

Treg-cell immunotherapy trials for COVID-19

Trial	Treatment	Population	Study design	Phase	Estimated enrollment	Blood disorder eligibility
NCT05027815	Cryopreserved ex vivo expanded polyclonal CD4⁺CD127^loCD25⁺ cells	18 to 70 y SARS-CoV-2 + RT-PCR Diagnosis of ARDS requiring intubation within 72 h of enrollment Chest imaging consistent with COVID-19 pneumonia	Nonrandomized, open label, dose escalation trial at 3 doses (100, 200, 400 × 10⁶ cells)	1/2 (recruiting)	18	Excluded for known or suspected immune suppression and/or a history of bone marrow or stem cell transplantation
NCT04468971	CK0802	≥18 y SARS-CoV-2 RT-PCR positive Moderate to severe ARDS Intubated for less than 120 h	Multicenter, double blinded, randomized, placebo-controlled safety and early efficacy trial Arm 1: placebo Arm 2: CK0802 at 1 × 10⁸ cells Arm 3: CK0802 at 3 × 10⁸ cells	1 (active, not recruiting)	45	Not excluded

Trial	Treatment	Population	Study design	Phase	Estimated enrollment	Blood disorder eligibility
NCT05027815	Cryopreserved ex vivo expanded polyclonal CD4⁺CD127^loCD25⁺ cells	18 to 70 y SARS-CoV-2 + RT-PCR Diagnosis of ARDS requiring intubation within 72 h of enrollment Chest imaging consistent with COVID-19 pneumonia	Nonrandomized, open label, dose escalation trial at 3 doses (100, 200, 400 × 10⁶ cells)	1/2 (recruiting)	18	Excluded for known or suspected immune suppression and/or a history of bone marrow or stem cell transplantation
NCT04468971	CK0802	≥18 y SARS-CoV-2 RT-PCR positive Moderate to severe ARDS Intubated for less than 120 h	Multicenter, double blinded, randomized, placebo-controlled safety and early efficacy trial Arm 1: placebo Arm 2: CK0802 at 1 × 10⁸ cells Arm 3: CK0802 at 3 × 10⁸ cells	1 (active, not recruiting)	45	Not excluded