GD2Bi-aATC

GD2Bi-aATC is an immunotherapy approach that consists of activated T cells (ATC) armed with anti-CD3 x anti-GD2 bispecific antibody (GD2Bi). This therapy is designed to redirect T cells to target GD2-positive tumors, particularly neuroblastoma and osteosarcoma[2][3]. The treatment involves collecting a patient's T cells, expanding and activating them ex vivo using CD3/CD28 beads, and then arming them with the GD2Bi antibody. These armed T cells (GD2BATs) are then infused back into the patient, typically along with low-dose IL-2 and GM-CSF as immune adjuvants[2][6]. ### Mechanism of Action GD2Bi-aATC works by redirecting the non-MHC restricted cytotoxicity of activated T cells to GD2-positive tumor cells. The bispecific antibody binds to both CD3 on T cells and GD2 on tumor cells, creating a bridge that allows the T cells to recognize and kill the tumor cells[2][6]. Preclinical studies have shown that GD2BATs effectively kill GD2-positive tumor targets, proliferate, and induce the release of Th1 type cytokines upon engagement with GD2-positive tumor targets[2][4]. ### Clinical Development GD2Bi-aATC has been investigated in a Phase I/II clinical trial (NCT02173093) for patients with GD2-positive tumors, including neuroblastoma, osteosarcoma, and desmoplastic small round cell tumors[3][5]. The trial followed a standard 3+3 dose escalation design with dose levels of 40, 80, and 160 × 10^6 GD2BATs/kg/infusion, administered twice weekly for a total of 8 infusions[3][6]. ### Safety Profile The treatment has demonstrated a manageable safety profile. The most common side effect is a mild, dose-independent form of cytokine release syndrome with grades 2-3 fevers/chills, headaches, and occasional hypotension for up to 48 hours after infusion[3]. Notably, patients did not develop significant pain, which is a common side effect with anti-GD2 antibody therapies[3]. The maximum tolerated dose was not reached in the Phase I study[3][6]. ### Clinical Efficacy Evidence of clinical activity has been observed in several patients, including: - A patient with osteosarcoma who had a PET response - A patient with neuroblastoma who had a complete bone marrow response and remained progression-free for 2.5 years after completing treatment - Another neuroblastoma patient who had a minor response on MIBG scan[3] The treatment has also been shown to induce endogenous immune responses, suggesting in vivo immunization of patients against their own tumor-associated antigens[2][6]. ### Current Status As of May 2025, GD2Bi-aATC continues to be investigated for the treatment of GD2-positive tumors, with evidence supporting further development in larger Phase II clinical trials[2].

Other names

GD2BATsGD-2BATsGD 2BATs