- The phase 1 clinical trial data for CLTX CAR T has unveiled a 75% disease control rate at lowest dose level (Level 1) of CLTX CAR T cells.
- CLTX CAR T (CHM 1101) is a novel and promising CAR T therapy for the treatment of patients with glioblastoma.
- CLTX CAR T was generally well tolerated with no dose limiting toxicities, and persistence of CLTX CAR T cells was shown throughout treatment.
Australian clinical stage cell therapy company Chimeric Therapeutics Limited (ASX:CHM) is set to present its two abstracts for CLTX CAR T at the 27th annual scientific meeting of the Society for Neuro-Oncology (SNO) on 19 November 2021.
The two abstracts, CTIM-29 and EXTH-10 have shown positive results from Chimeric’s CLTX CAR T phase 1 clinical trial.
CLTX CAR T (CHM 1101) is a novel and promising CAR T therapy for treating glioblastoma patients. The therapy, developed by scientists at the City of Hope Medical Centre in California, is currently being studied in a phase 1 clinical trial.
“Clinical evaluation of chlorotoxin-directed CAR T cells for patients with recurrent glioblastoma”, Abstract CTIM-29 sheds light on the CLTX preliminary clinical data.
The clinical data released in this abstract is from the ongoing CLTX CAR T phase 1 clinical trial in four patients with MMP2+ recurrent or progressive glioblastoma. Enrolled in dose level 1 of the trial, the patients were treated with 44 X 106 CLTX CAR T cells via a single route of intratumoral administration.
Within patients treated at dose level 1, a 75% disease control rate was shown, given three out of the four patients treated achieved a best response of stable disease assessed by RANO (response assessment in neuro-oncology).
Moreover, the CLTX CAR T cells were generally well tolerated during the trial, with none of the patients experiencing a dose limiting toxicity. One patient experienced a grade 3 cerebral edema, an adverse event commonly observed in patients with glioblastoma. However, the occurrence was only possibly attributed to the CAR T cells.
Bioactivity of the cells was also demonstrated as persistent CLTX CAR T cells were detected in the tumour cavity throughout treatment, as indicated by liquid biopsy. It suggests that the CLTX CAR T cells are not immunogenic and cannot impact the persistence and efficacy of the CAR T.
In the Phase 1 study, dose escalation is planned across four dose levels to a total dose of 440 X 106 CLTX CAR T cells. These will be administered through dual intraventricular and intratumoral routes of administration.
“Exploration of a novel toxin-incorporating CAR T cell: how does chlorotoxin recognize glioblastoma cells?”, Abstract EXTH-10 expands on the translational understanding of Chlorotoxin (CLTX) activity.
The translational data available in abstract EXTH-10 focuses on the precise composition and structure of the cell surface complex recognised by CLTX CAR T. It thereby confirms that the correlation between MMP-2 expression and CLTX binding supports the rationale for exploring MMP-2 as a correlative marker for response to CLTX CAR T in Phase 1 studies.
About CLTX CAR T Clinical Trial
The CLTX CAR T phase 1 clinical trial is currently underway at a single site in California with plans to expand to a multi-site trial in 2022. The design is a single arm, open label trial in patients with MMP2+ recurrent or progressive glioblastoma.
The trial is planned with four dose levels ranging from 44 X 106 to 440 X 106 CLTX CAR T cells. It studies both single and dual routes of administration of cells.
Source: CHM Update, dated 15 November 2021
In April this year, dose level 1 was wrapped up with no dose limiting toxicities. The primary endpoints of the trial are:
- To assess the safety of CLTX CAR T cells
- Determine the maximum tolerated dose schedule
- Recommended Phase 2 dosing plan
Meanwhile, the trial’s secondary endpoints include bioactivity and efficacy measures.
The Company indicated that additional insight may be provided when the abstracts are fully presented at the SNO meeting.
CHM shares traded at AU$0.317 on 15 November 2021 (AEST: 03:09 PM).