CD19 CAR T-cell therapy (GLPG5101) for relapsed or refractory B-cell non-Hodgkin lymphoma (ATALANTA-1): phase 1 results from a single-arm, multicentre, phase 1/2 study.

What was studied

This early trial tested GLPG5101, a fresh CD19 CAR T-cell product, in B-cell non-Hodgkin lymphoma. The cells are made in a decentralised way. It ran in 5 hospitals in the Netherlands and Belgium. 24 adults who had tried earlier therapies got one infusion. There were 3 dose levels. The goals were safety and a dose for the next phase.

What they found

Median age was about 66 years. Median follow-up was about 24 months. 5 dose-limiting toxicities were reported. One was a death from bleeding inside the belly. All 23 people in the safety group had grade 3 or higher side events. Neutropenia was most common, in 22 people. Treatment-related deaths occurred in 4 people. The safety committee picked a phase 2 dose.

What it means for patients

The authors say fresh CAR T-cells can be made and given across hospitals. They call this feasible in people who had much prior therapy. They say the phase 2 part will give more on activity and safety.

Why it is not certain yet

Only 24 people took part. There was no comparison group. The abstract does not give tumor response results. Serious harms, including deaths, occurred. This is an early trial.

Source

CD19 CAR T-cell therapy (GLPG5101) for relapsed or refractory B-cell non-Hodgkin lymphoma (ATALANTA-1): phase 1 results from a single-arm, multicentre, phase 1/2 study.

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