FDA Grants RMAT Designation to Galapagos NV’s CART Therapy for Mantle Cell Lymphoma

The FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to GLPG5101, an experimental CAR T-cell therapy being developed by Galapagos NV. This designation is specifically for the treatment of patients with relapsed/refractory mantle cell lymphoma (MCL) and is based on promising clinical data from the ongoing Phase 1/2 ATALANTA-1 trial.

Promising Clinical Trial Results

GLPG5101 is being evaluated in patients with several types of B-cell non-Hodgkin lymphomas. The RMAT designation was granted following a review of data from the trial, which, as of January 21, 2025, showed high objective response rates (ORR) and complete response (CR) rates. The therapy has also demonstrated a manageable safety profile with low rates of severe side effects like cytokine release syndrome (CRS) and neurotoxicity syndrome (ICANS).

Prior data, presented at the 2024 ASH Annual Meeting, highlighted the therapy’s efficacy:

• Mantle Cell Lymphoma (MCL): 100% ORR and CR rate among the 8 patients evaluated.
• Marginal Zone/Follicular Lymphoma: 95% ORR and CR rate.
• Diffuse Large B-cell Lymphoma (DLBCL): 69% ORR and 54% CR rate.

The RMAT designation is expected to accelerate the development and FDA review process for GLPG5101, allowing for a closer collaboration with the FDA to bring this potential new treatment to patients faster.

How the ATALANTA-1 Trial Works

The ATALANTA-1 trial is a multi-center study investigating the safety and effectiveness of GLPG5101 in various lymphomas.

• Phase 1 focused on finding the right dose for the therapy by testing different levels of CAR T-cells.
• Phase 2 is now evaluating that optimal dose in different groups of patients, with the MCL group being a key focus.

Patients eligible for the trial must have specific relapsed/refractory B-cell lymphomas, be at least 18 years old, and meet certain health criteria. The trial excludes patients with other active cancers, unresolved side effects from previous therapies, or certain health conditions like significant heart or neurological disease. The main goal for most groups in Phase 2 is to measure the objective response rate, or how many patients see their cancer shrink or disappear.