Chimeric Therapeutics Shows Tumour Shrinkage at Highest CAR-T Dose
Chimeric Therapeutics reports encouraging interim data from its Phase 1/2 trial of CHM CDH17 CAR-T therapy, with tumour shrinkage up to 40% and stable disease maintained for months at the highest dose level.
- Four patients treated at 450 million CAR-T cells dose
- Tumour shrinkage between 17% and 40% in individual lesions
- Stable disease maintained up to six months in two patients
- No new safety concerns beyond initial dose-limiting toxicity
- Final two patients to be dosed by end of 2026 pending funding
Promising Tumour Responses at Highest Dose Level
Chimeric Therapeutics (ASX:CHM) has delivered encouraging early data from its Phase 1/2 clinical trial of CHM CDH17, a novel CAR-T cell therapy targeting advanced gastrointestinal cancers. Four patients have now been treated at the highest dose level of 450 million CAR-T cells, with interim results from two showing tumour shrinkage ranging from 17% to 40% in individual lesions. Both patients have maintained stable disease for periods of four and six months respectively, as assessed by RECIST 1.1 criteria.
Safety Profile Remains Manageable with No New Signals
Since a previously reported dose-limiting toxicity in May 2026, no additional safety concerns have emerged at Dose Level 3. The company continues to monitor patients closely for adverse events, with the safety profile so far consistent with expectations for CAR-T therapies. This stability supports advancing the trial towards dose selection for Phase 2 expansion cohorts.
Trial Progress and Future Patient Dosing
Chimeric has completed manufacturing for a fifth patient at the highest dose, with dosing expected imminently. The sixth and final patient in the Phase 1 portion is planned to be dosed by the end of 2026, subject to funding availability. This trial aims to establish a recommended Phase 2 dose and evaluate safety and efficacy across colorectal, gastric, and neuroendocrine tumours.
Strategic Implications of Clinical Data
Non-Executive Chairman Dr Bradley Glover emphasised that the evolving clinical dataset strengthens confidence in CHM CDH17 as a platform technology rather than a single asset. The biology and clinical experience generated could underpin future cell therapy modalities, potentially broadening the company’s pipeline and long-term value.
Trial Design and Patient Eligibility
The Phase 1/2 open-label study involves dose escalation followed by expansion cohorts, enrolling patients with relapsed or refractory gastrointestinal cancers who have exhausted at least one standard treatment. Key eligibility includes measurable disease by RECIST criteria, adequate organ function, and no prior CDH17-targeted therapy. The trial incorporates bridging chemotherapy options and follows patients for up to 18 months or until disease progression.
Bottom Line?
While early signs of efficacy at the highest CAR-T dose are promising, the small patient numbers and pending Phase 2 dose selection mean investors should watch closely for broader data and funding developments.
Questions in the middle?
- Will the remaining Dose Level 3 patients confirm the tumour shrinkage and disease stability signals?
- How will funding constraints impact the timing and scale of Phase 2 trial expansion?
- Can CHM CDH17’s platform potential translate into additional cell therapy modalities beyond gastrointestinal cancers?
