Chimeric Therapeutics doses first patient in CHM 1101 Phase 1B trial to treat glioblastoma
Chimeric Therapeutics (ASX: CHM) has confirmed the first patient in its Phase 1B clinical trial into recurrent or progressive glioblastoma multiforme (GBM) has received a dose of CHM 1101 CAR T cell therapy.
The patient was dosed under the Sarah Cannon Transplant & Cellular Therapy program at St David’s South Austin Medical Center in Texas.
CHM 1101 was used as a second line therapy.
Chimeric managing director Jennifer Chow said it was a key milestone in the company’s development program.
“We are thrilled to have reached this point in the advancement of CHM 1101,” she said.
“We believe the full potential of this therapy for patients with recurrent and progressive glioblastoma will be unlocked through the advancement of our clinical development program and we look forward to continuing to move this trial forward.”
Chief medical officer Jason Litten said he was excited to have initiated the first patient under the Phase 1B trial, which builds off recent positive Phase 1A clinical data.
“We are looking forward to advancing the clinical development of this unique and potentially transformative cell therapy for patients with this devastating disease,” he said.
CHM 1101 is a first-in-class, autologous chlorotoxin CAR T treatment developed for the treatment of patients with solid tumours.
The Phase 1B clinical trial is being conducted under a US investigational new drug application and is designed in two parts.
Part A comprises dose confirmation and Part B will investigate dose expansion.
The first patient was treated in Part A of the Phase 1B trial as part of the initial dose confirmation cohort.
Phase 1A data
Advancement to Part B of the trial was designed to be contingent upon data from Phase 1A, which focused on heavily pre-treated patients who received CHM 1101 as a fourth line therapy.
It demonstrated a 55% disease control rate (DCR); an average 10 months survival in patients who achieved disease control; and a manageable safety profile.
One patient exceeded 18 months survival, while two other patients have exceeded 14 months survival and three remain alive and in follow-up treatment.
On completion of the Part B dose expansion cohort, Mr Litten said the company would design and initiate a registration trial in collaboration with global regulatory feedback.