Therapy types in clinical development highlighted below for the treatment of ALS include cell and gene therapies along with small molecule drugs. An autologous T-cell therapy, RAPA-501, was developed by RAPA Therapeutics to address the lack of compounds for treatment of neuroinflammation in ALS and is currently recruiting for a Phase II/III clinical trial (NCT04220190). This trial is an expansion cohort that was added to access RAPA-501 cells efficiency in standardrisk ALS patients. In this ongoing clinical trial, RAPA-501 cells were found to be safe, have multiple anti-inflammatory effects, and showed early signs of preserving pulmonary function. RAPA-501 cells express both the TREG and Th2 transcription factors forkhead box P3 (FOXP3) and GATA-binding protein 3 (GATA3), are enriched for expression of the T-cell homing molecule CD103 and the ATP ectonucleotidase molecules CD39 and CD73. They also suppress effector T-cell inflammatory molecules and CNS microglial cell inflammatory molecules. RAPA-501 cells are also available through an expanded access clinical trial (NCT06169176) to patients living with high-risk ALS and are not eligible for other ALS clinical trials. These trials will research therapy feasibility, safety, and efficacy including biomarker measurements for neuroinflammation.