The first patient has been dosed in Celyad Oncology’s Phase 1 clinical trial evaluating CYAD-211, an investigational donor-derived CAR T-cell therapy for treating relapsed or refractory multiple myeloma.
The IMMUNICY-1 trial (NCT04613557) intends to recruit 12 patients who received two or more prior lines of treatment, including an immunomodulatory agent and a proteasome inhibitor. Enrollment is ongoing in Belgium and the U.S.
“Dosing the first patient with CYAD-211 marks another major milestone to systematically advance our pipeline of non-gene edited allogeneic CAR T candidates,” Frédéric Lehmann, MD, vice-president of clinical development and medical affairs at Celyad Oncology, said in a press release.
“Enrollment in the IMMUNICY-1 trial will continue over the coming months and we expect to report proof-of-concept data from the initial dose cohorts [groups] of the trial during the first half of 2021,” Lehmann added.
Celyad is focused on the discovery and development of chimeric antigen receptor T-cell therapy, or CAR T-cell therapy, in which T-cells (a type of immune cell) are collected and genetically engineered to target and eliminate specific cancer cells.
CYAD-211 is an investigational donor-derived (allogenic) CAR T-cell therapy in which T-cells are modified to target the B-cell maturation antigen (BCMA), a protein that is highly produced by myeloma cells.
A second component of this investigational treatment is a short hairpin RNA (shRNA) that aims to reduce a specialized protein receptor that occurs naturally in T-cells — the T-cell receptor (TCR) — and helps these cells recognize their targets during an immune response.
While CYAD-211’s first component seeks to make the therapy an effective treatment for myeloma, the second seeks to reduce the risk of graft-versus-host disease, a potentially life-threatening condition in which donor immune cells attack the patient’s healthy tissue.
“BCMA is highly expressed in multiple myeloma patients and we hope to see a positive clinical benefit with our approach of targeting BCMA with our first-in-class CAR T which is underpinned by our shRNA technology,” Lehmann said.
IMMUNICY-1 is an open-label, dose-escalation study testing the safety and clinical activity of a single CYAD-211 infusion in adults with myeloma who have relapsed from or are refractory (resistant) to standard therapy.
Before receiving CYAD-211, patients undergo a chemotherapy regimen — consisting of fludarabine and cyclophosphamide — that aims to eliminate existing cancer cells and to create room for the modified T-cells.
Participants then will receive ascending doses of CYAD-211, ranging from 30 to 300 million cells, to determine the most effective and safest dose for further trials.
“We are proud to participate in the IMMUNICY-1 trial which will evaluate CYAD-211 in the treatment of relapsed or refractory multiple myeloma patients,” said Sébastien Anguille, PhD, a CAR-T specialist at the Antwerp University Hospital.
“Based on the encouraging preclinical data, we believe this new allogeneic CAR T targeting BCMA has the potential to become an important therapy for such a challenging patient population,” Anguille said.
Celyad also received additional €3.4 million (about $4.1 million) in funding from SPW-Recherche of the Walloon Region, Belgium, in the form of recoverable cash advances, for the development of CYAD-211.
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