Although the TCB-202-001 trial ended prematurely due to the COVID-19 pandemic, promising results warrant a phase 2 trial.
Infusion of OmnImmune, an allogeneic Vγ9Vδ2 cell therapy, was safe in patients with acute myeloid leukemia (AML) enrolled in the phase 1 TCB-202-001 trial clinical trial (NCT03790072) and warrant further study in a phase 2 trial, according to recent data published in Clinical Lymphoma Myeloma and Leukemia.1
"I feel privileged to be part of the team that achieved the successful publication on our phase I trial using OmnImmune® (haploidentical allogeneic γδ T lymphocytes) in advanced AML patients," Emilio Cosimo, PhD, Director, Product Development, TC Biopharm, said in a statement.2 "The study shows the safety of this type of cell therapy and is the basis for TCB's next steps in the allogeneic cell therapy sector."
The trial dosed 7 participants with 106/kg (n = 3), 107/kg (n = 3), or 108/kg (n = 1) allogeneic γδ T cells.1 Five participants survived to day 14 post treatment; 1 died from infection on day 14 that was deemed unrelated to the cell therapy, and another discontinued the study at day 14 due to disease progression, leaving 4 that were evaluated at day 28 post treatment.All participants received fludarabine (4 days, 25-50 mg/m2) and cyclophosphamide (2 days, 500 mg/m2) lymphodepletion
Investigators found that 1 patient had a complete remission (CR), 1 had a morphologic leukemia-free state, 1 had stable disease, and 1 had no evidence of response. One of these patients had evidence of disease control with repeat infusions up to 100 days after first dosing. The trial terminated prematurely due to the COVID-19 pandemic.
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”The contribution of lymphodepleting chemotherapy to responses seen cannot be ruled out. Main limitation of the study is the low number of patients and interruption due to COVID-19 pandemic,” first author Jan Vydra, PhD, Institute of Haematology and Blood Transfusion, Prague, Czech Republic, and colleagues wrote.1 “These positive phase 1 results support progression to phase 2 clinical trials.”
Vγ9Vδ2 cells were well-tolerated, with no treatment-related serious adverse events, up to a cell dose of 108/kg. No cases of graft versus host disease or neurotoxicity were observed. One patient experienced a possible grade 1 case of cytokine release syndrome, although symptoms were nonspecific.
"The results of our phase I clinical trial of γδ T cell immunotherapy of advanced AML support further research and development of this cell therapy platform, as it was shown to be both safe and feasible in this setting,” Vydra added to the statement.2
Patients that survived past 28 days were reinfused without additional lymphodepletion and no dose-limiting toxicities were observed.1 The 3 responding patients have had continued or deepened responses.
"This marks the first publication generated by TC Biopharm, a hallmark moment for our company and our team to be recognized within the industry," Bryan Kobel, chiefexecutive officer, TC BioPharm, added.2 "I'd like to thank Dr. Vydra for all his hard work running the study and our former clinical director, Tomasz Zaremba, as well as Angela Scott, Dr. Mike Leek, Dr. Sebastian Wanless, Dr. Emilio Cosimo and the rest of the contributors. We look forward to additional publications in the future from our team."