CK0802 / Cellenkos - LARVOL DELTA

CK0802 for Treatment of Steroid Refractory Graft vs. Host Disease (GVHD) (clinicaltrials.gov) - P1/2 | N=12 | Not yet recruiting | Sponsor: Cellenkos, Inc.

New P1/2 trial • Graft versus Host Disease • Immunology

Cellenkos…announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug application to initiate a Phase 1b/ 2a clinical trial of CK0802 for the treatment of patients with steroid-refractory graft-versus-host disease (GVHD) (PRNewswire) - "The multicenter, open-label Phase 1b/ 2a trial is designed to evaluate the safety, tolerability, and preliminary efficacy of multiple infusions of CK0802....The trial is scheduled to commence in the second half of 2026, with a clinical readout anticipated in early 2027."

IND • New P1/2 trial • Graft versus Host Disease

Randomized, Multi-Center, Double-Blinded, Placebo Controlled Safety and Early Efficacy Trial of Cryopreserved Cord Blood Derived T-Regulatory Cell Infusions (CK0802) in the Treatment of COVID-19 Induced ARDS. (RESOLVE Trial) (ASH 2021) - "Full data analysis of treatment groups (placebo; CK0802-100 million; CK0802-300 million) is ongoing and will be presented at the conference. Additional data to be presented will include: 3- and 6- month QOL, mental health, and cognitive index analyses, and paired Biomarker analysis."

Clinical • Acute Respiratory Distress Syndrome • Immunology • Infectious Disease • Inflammation • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases

RESOLVE: REgulatory T Cell infuSion fOr Lung Injury Due to COVID-19 PnEumonia (clinicaltrials.gov) - P1 | N=45 | Completed | Sponsor: Cellenkos, Inc. | Active, not recruiting ➔ Completed

Trial completion • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases

RESOLVE: REgulatory T Cell infuSion fOr Lung Injury Due to COVID-19 PnEumonia (clinicaltrials.gov) - P1; N=45; Active, not recruiting; Sponsor: Cellenkos, Inc.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases

RESOLVE: REgulatory T Cell infuSion fOr Lung Injury Due to COVID-19 PnEumonia (clinicaltrials.gov) - P1; N=45; Recruiting; Sponsor: Cellenkos, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

RESOLVE: REgulatory T Cell tranSfusion fOr Lung Injury Due to COVID-19 PnEumonia (clinicaltrials.gov) - P1; N=45; Not yet recruiting; Sponsor: Cellenkos, Inc.

Clinical • New P1 trial • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

Johns Hopkins Reports Promising Clinical Data in COVID-19 ARDS Treated with Cellenkos' Cord Blood T-Regulatory Cells (PRNewswire) - P=NA, N=2; "Physician-investigators at Johns Hopkins University Hospital report on the promising data of treatment of COVID-19 induced acute respiratory distress syndrome with allogeneic, cord blood derived T-regulatory (Treg) cell therapy....Patients received cell therapy under FDA Emergency Use IND for up to 3 doses. Clinical improvement was evident within 48 hours of first infusion and correlated with concurrent dampening of the cytokine storm....The multicenter clinical trial is set to launch in Q3 2020..."

Clinical data • Cytokine storm • New trial • Infectious Disease • Novel Coronavirus Disease

Cellenkos Inc. announces FDA clearance to initiate phase 1 double- blinded, randomized, placebo-controlled trial of cryopreserved cord blood-derived T-regulatory cells (CK0802) for treatment of Covid-19 associated acute respiratory distress syndrome (PRNewswire) - "Cellenkos Inc....announced today that the US Food & Drug Administration (FDA) has cleared the way to initiate a Phase 1 clinical trial of CK0802 (Cryopreserved Cord Blood Derived T-Regulatory Cells) for treatment of COVID-19....The trial is designed as a randomized, double-blinded, placebo-controlled study to assess safety and preliminary efficacy in this hospitalized patient population....'CK0802 will be assessed for both toxicity and 28-day treatment success, as co-primary outcomes.'"

New P1 trial • Infectious Disease • Novel Coronavirus Disease