Chimeric Therapeutics reports 82% disease control rate in CAR-T trial at ASCO 2026
Chimeric Therapeutics (ASX: CHM) has reported that 9 of 11 evaluable patients (82%) achieved stable disease per RECIST in its CHM CDH17 (CHM-2101) Phase 1/2 trial (NCT06055439), with data presented at the American Society of Clinical Oncology (ASCO) annual meeting on 1 June 2026. One patient has maintained stable disease for over 15 months, another for 12 months, with three patients remaining on study. The company is hosting an investor webinar at 11am AEST today to discuss the results.
When big ASX news breaks, our subscribers know first
What the Phase 1/2 data shows
The current update strengthens an already encouraging dataset. The interim readout reported in November 2025 showed a 75% disease control rate in 6 of 8 evaluable patients at the 28-day assessment. The latest data cut, reflecting additional patients treated, the commencement of Dose Level 3, translational data, and longer follow-up, now shows an 82% disease control rate across 11 evaluable patients.
Efficacy and enrolment snapshot
As of the 12 May 2026 data cut, enrolment and manufacturing results were as follows:
- 16 subjects enrolled, with 2 screen failures
- 100% manufacturing success rate (15 of 15 runs), enabling treatment of 12 subjects
- 4 patients at Dose Level 1 (50×10⁶ cells); 6 patients at Dose Level 2 (150×10⁶ cells); 2 patients at Dose Level 3 (450×10⁶ cells)
- 11 evaluable patients; 9 achieved stable disease per RECIST 1.1
- Dose Level 3 enrolment is ongoing; the Recommended Phase 2 Dose (RP2D) is expected to follow
The patient demographics and prior therapy lines by dose level are summarised below.
| Dose Level | Age (median, range) | Gender | Diagnosis | Prior Lines of Therapy (median) |
|---|---|---|---|---|
| Dose Level 1 (50×10⁶) | 49.5 (27–63) | 1M / 3F | 1 NET (Grade 3), 3 CRC (Grade 2) | 4 (range 1–8) |
| Dose Level 2 (150×10⁶) | 49 (37–76) | 4M / 2F | 3 NET (Grade 2 & unknown), 3 CRC (Grade 2) | 4 (range 2–12) |
| Dose Level 3 (450×10⁶) | 52.5 (45–60) | 1M / 1F | 2 CRC (Grade 2) | 4 (range 3–5) |
| Total | 49 (27–76) | 6M / 6F | 4 NET / 8 CRC | 4 (range 1–12) |
Safety profile
The safety data from CHM CDH17 is consistent with known cell therapy class effects across the patient population studied.
- One Dose-Limiting Toxicity (DLT) was observed
- Grade 3 Treatment-Related Adverse Events (TRAEs) included Cytokine Release Syndrome (CRS), enterocolitis, neutropenic fever, and fatigue, all of which have resolved
- No Grade 4 or 5 TRAEs were recorded
- Grade 4 Treatment Emergent Adverse Events (TEAEs) were associated with lymphodepletion prior to receiving therapy, a pre-treatment step involving chemotherapy used to prepare the immune system for CAR-T infusion
The announcement explicitly noted that these toxicities have been “well documented in all cell therapy treatments regardless of target or indication,” contextualising the profile as a known class effect rather than a therapy-specific concern. The population studied was heavily pre-treated metastatic cancer patients, a group for whom tolerability data is particularly meaningful. CHM described CHM CDH17 as tolerable in this setting, with evidence of disease control.
Understanding CAR-T therapy and why CDH17 is a compelling target
CAR-T (Chimeric Antigen Receptor T-cell) therapy involves extracting a patient’s own T-cells, engineering them in a laboratory to recognise a specific protein found on cancer cells, and then infusing them back into the patient to identify and destroy those cancer cells. T-cells are a type of white blood cell that plays a central role in the body’s immune response.
CHM CDH17 is a 3rd generation CAR-T, which matters because each successive generation has incorporated additional co-stimulatory domains, the molecular signals that help engineered T-cells survive longer and function more effectively after infusion. Third generation constructs are designed to improve persistence inside the body compared to earlier iterations.
The target itself, CDH17, is a cancer biomarker (a biological marker that indicates the presence or behaviour of cancer) associated with poor prognosis and metastasis in the most common gastrointestinal (GI) tumours. GI cancers, including colorectal cancer, gastric cancer, and neuroendocrine tumours (NETs), account for more than 1.3 million deaths globally per year. Despite advances in treatment, patients with relapsed or refractory disease in the metastatic setting continue to face poor outcomes, underpinning the unmet medical need this trial is designed to address.
CHM CDH17 was invented at the University of Pennsylvania in the laboratory of Dr Xianxin Hua. Preclinical evidence published in Nature Cancer in 2022 demonstrated complete eradication of tumours in 7 types of cancer in mice, a foundational data set that informed the clinical programme now generating human efficacy signals.
RECIST 1.1: Understanding the response categories
RECIST 1.1 (Response Evaluation Criteria In Solid Tumours) measures changes in tumour size on scans and classifies patient responses into four categories:
- Complete Response (CR): All visible tumours have disappeared
- Partial Response (PR): Total tumour size has shrunk by at least 30%
- Stable Disease (SD): The cancer has shrunk up to 30% or has not grown more than 20% from nadir
- Progressive Disease (PD): Tumour growth of 20% or more, or the appearance of new tumours
The 82% disease control rate reported by Chimeric reflects the proportion of evaluable patients who achieved Stable Disease (SD) — meaning their cancer did not meaningfully progress following treatment.
What comes next for Chimeric Therapeutics
Pathway to Phase 2
The trial follows a structured two-stage design. The next clinical steps are:
- Complete Dose Level 3 enrolment (450×10⁶ cells; 2 patients enrolled to date)
- Determine the Recommended Phase 2 Dose (RP2D) based on Phase 1 findings
- Proceed to Phase 2 expansion using a Simon 2-Stage Design across three indication-specific cohorts: Colorectal Cancer (up to 29 subjects), Gastric Cancer (up to 29 subjects), and Midgut/Hindgut NETs (up to 29 subjects)
- The Phase 1 portion targets up to 15 evaluable patients total before dose selection and expansion
Persistence data as a de-risking signal
One of the more strategically significant findings in the data package is the pharmacokinetic profile. CHM CDH17 CAR T+ cells expanded and persisted in the peripheral blood of all treated patients for up to 15 months post-infusion. For context, persistence of engineered T-cells in solid tumour settings has historically been a challenge for the broader CAR-T field. Demonstrating sustained presence across all treated patients, and across multiple dose levels, is a meaningful differentiating data point as the programme advances toward Phase 2.
Dr Rebecca McQualter, Chief Executive Officer
“It’s very pleasing to see these continued positive results and a proud moment for the company to have them presented at ASCO. We look forward to continuing at Dose Level 3 and determining the dose appropriate for Phase 2.”
Investors seeking further detail on the Phase 1/2 results can attend the investor webinar being held at 11am AEST, 1 June 2026. A recording will be made available via Chimeric’s website and social media channels following the conclusion of the live session.
Don’t Miss the Next Healthcare Breakthrough
Big News Blast delivers FREE breaking ASX healthcare news directly to your inbox within minutes of release, complete with in-depth analysis. Join 20,000+ subscribers already getting the edge on market-moving announcements the moment they drop. Click the “Free Alerts” button to stay ahead on ASX healthcare stocks before the market moves.