- Center on Health Equity & Access
- Clinical
- Health Care Cost
- Health Care Delivery
- Insurance
- Policy
- Technology
- Value-Based Care
FDA Accepts First Allogeneic CAR T-Cell Therapy Trial
Celyad, a biopharmaceutical company that focuses on the development of chimeric antigen receptor (CAR) T-cell therapies, recently announced that the FDA has accepted its Investigational New Drug (IND) application for CYAD-101, the first non–gene-edited allogeneic clinical program.
Celyad, a biopharmaceutical company that focuses on the development of chimeric antigen receptor (CAR) T-cell therapies, recently announced that the FDA accepted its Investigational New Drug (IND) application for CYAD-101, the first non—gene-edited allogeneic clinical program.
Traditionally, CAR T-cell therapies are created by genetically modifying a patient’s own immune cells to target specific cancer cells before injecting them back into the patient. However, this can be difficult because researchers aren’t always able to collect enough cells from a patient to create the treatment. Conversely, in an allogeneic CAR T-cell therapy, immune cells are instead collected from healthy donors, rather than the patient.
The trial, titled Allo-SHRINK, looks to evaluate the safety and clinical activity of CYAD-101 in patients with unresectable colorectal cancer in combination with standard chemotherapy.
“We are pleased to have achieved this important milestone. Celyad is the first company clinically evaluating a non-gene edited CAR T candidate, which, we believe, offers significant advantages over gene-edited approaches,” Christian Homsy, MD, CEO of Celyad, said in a statement.
CYAD-101 is based on features of the company’s investigational autologous CYAD-01 CAR T with a novel peptide, TCR Inhibiting Molecule (TIM). This prevents the patients’ immune system from recognizing the cells as foreign. The cells in CYAD-01 produce a chimeric receptor called natural killer group 2D (NKG2D) that recognizes multiple tumor proteins.
Celyad’s investigational autologous CYAD-01 treatment is currently being tested in 3 phase 1 trials for different cancers, including SHRINK, which is investigating increasing doses CYAD-01 with chemotherapy in patients with colorectal cancer whose liver metastasis can be removed by surgery; LINK, which is examining increased doses of CYAD-01 in patients with colorectal cancer with liver metastases that cannot be removed by surgery; and THINK, which is evaluating CYAD-01 in 7 types of refractory cancers, including 5 solid tumors.
“Our non-gene edited program consists of a family of technologies aimed at reducing or eliminating T cell receptor (TCR) signaling without requiring genetic manipulation. CYAD-101 is part of a robust clinical development plan, establishing the foundations of next generation CAR T products,” said Homsy.
Exploring Racial, Ethnic Disparities in Cancer Care Prior Authorization Decisions
October 24th 2024On this episode of Managed Care Cast, we're talking with the author of a study published in the October 2024 issue of The American Journal of Managed Care® that explored prior authorization decisions in cancer care by race and ethnicity for commercially insured patients.
Listen
Addressing Cancer Care Challenges for Patients, and Ensuring Equity: Coral Omene, MD, PhD
June 22nd 2025Delivering value-based cancer care requires overcoming hurdles to access care and tailoring care that prioritizes the quality-of-life metrics the patient values, explained Coral Omene, MD, PhD.
Read More
Examining Low-Value Cancer Care Trends Amidst the COVID-19 Pandemic
April 25th 2024On this episode of Managed Care Cast, we're talking with the authors of a study published in the April 2024 issue of The American Journal of Managed Care® about their findings on the rates of low-value cancer care services throughout the COVID-19 pandemic.
Listen
