Dose Level 2-Baylor College of Medicine-chronic lymphocytic leukemia

Dose Level 2-Baylor College of Medicine-chronic lymphocytic leukemia refers to a specific dosage cohort in a Phase I clinical trial (CLIPA/CLIMAT) evaluating an autologous cell-based immunotherapy for chronic lymphocytic leukemia (CLL). Developed by Baylor College of Medicine, the therapy consists of a patient's own B-CLL tumor cells that have been genetically modified, typically using adenoviral vectors, to express human CD40 ligand (CD40L) and secrete interleukin-2 (IL-2). At Dose Level 2, the treatment is administered as an injection containing a fixed dose of 2 x 10^7 IL-2-secreting cells and an escalated dose of 2 x 10^6 CD40L-expressing cells. The mechanism of action involves CD40L-mediated activation of the CD40 receptor on leukemia cells and antigen-presenting cells to enhance their immunogenicity (upregulating MHC and costimulatory molecules), while IL-2 acts as an agonist for IL-2 receptors to promote the expansion and activation of anti-tumor T-cells. The modified cells are irradiated prior to administration to serve as a therapeutic vaccine, stimulating a systemic anti-leukemic immune response.

Other names

Ad-hCD40L/Ad-hIL-2-modified autologous CLL cellsAutologous IL-2/CD40L-modified B-CLL cellsCD40L/IL-2-modified autologous B-CLL cells