Abstract 300P
Background
Glioblastoma is the most common intracranial malignant tumors, which is difficult to treat and has poor prognosis. T cell immunotherapy is becoming a powerful strategy for the treatment of cancer and may provide an opportunity to improve the prognosis of patients with advanced glioma.This trial has three purposes: 1) to evaluate the safety and feasibility of allogeneic CAR-T cells in human body; 2) Lumbar injection and intratumoral injection were compared; 3) Preliminarily evaluate the effectiveness of our product in patients with advanced glioma.
Methods
We are developing allogeneic universal CAR-T cells for IL13Rα2 (IL13Rα2 UCAR-T cells) for the treatment of advanced glioma. This is a off-the-shelf anti- IL13Rα2 allogeneic CAR-T cells candidate product, which is made of a series of healthy donor materials, avoiding many shortcomings of autologous car-t products. We report here initial findings from our first-in-human clinical trial [ChiCTR2000028801].
Results
We have treated a total of 7 patients, and the longest time after the first injection has been 21 months. The most common side effects are fever and anorexia. The significant increase of inflammatory factors such as interleukin-6 and interleukin-8 can be detected in cerebrospinal fluid, but the cytokine storm seen in the application of CAR-T cells in hematologic malignancies is not seen. Among the 7 patients, one patient had complete remission (CR) and lasted for 10 months, 4 patients had partial remission (PR), which was defined as tumor regression of more than 50%, and 2 patients had disease stability (SD). Therefore, the overall effective rate was 71.42% (5 / 7) and the disease control rate was 100% (7 / 7). The patient with the longest follow-up had survived for 18 months after the first injection. We monitored the number of IL13Rα2 UCAR-T cells in cerebrospinal fluid by flow cytometry or copy number detection. We found that our IL13Rα2 UCAR-T cells could survive in cerebrospinal fluid for more than 30 days.
Conclusions
These early clinical findings suggest that lumbar puncture delivery of allogeneic IL13Rα2 UCAR-T cells is safe and well-tolerated, and that IL13Rα2 UCAR T cells are capable of eliciting potent antitumor responses against recurrent glioma.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Jiangsu T-Maximum Biotech Co., Ltd.
Disclosure
All authors have declared no conflicts of interest.