Cell Therapy Shrinks Tumors in 63%
A new cell therapy achieved tumor shrinkage in 63% of advanced mesothelioma patients. More than double typical response rates.
Australian biotechnology company AdAlta Limited and its cellular immunotherapy subsidiary AdCella have announced a development partnership with Shanghai Cell Therapy Group (SHcell) to advance BZDS1901, a first-in-class CAR-T therapy. In early clinical data, BZDS1901 demonstrated a 63.5% response rate in patients with advanced mesothelioma.
The collaboration, announced January 15, 2026, represents progress in the ongoing effort to develop CAR-T therapies for solid tumors. While CAR-T treatments have transformed care for some blood cancers, adapting them for solid tumors like mesothelioma has proven more difficult.
BZDS1901 Clinical Results
Early clinical data from investigator-initiated trials in China, reported by Shanghai Cell Therapy Group, showed the following results in patients with advanced mesothelioma treated with first-generation BZDS1901:
- 63.5% objective response rate, including one complete response
- 73% of treated patients survived more than 12 months
Updated data on a second-generation version of BZDS1901 reported a 42.9% objective response rate in 14 evaluable patients, with 14.3% complete responses. Neither dataset has been published in peer-reviewed literature. These results come from company disclosures and should be interpreted as early signal rather than confirmatory evidence.
For context, current standard treatments for mesothelioma typically yield response rates of 11% to 29% and median overall survival of 8.4 to 8.7 months.
How BZDS1901 Works
BZDS1901 targets mesothelin (MSLN), a protein highly expressed on mesothelioma cells as well as non-small cell lung cancer, ovarian cancer, and pancreatic cancer cells.
What distinguishes BZDS1901 from other mesothelin-targeting CAR-T approaches is its “armored” design. The therapy includes a PD-1-blocking nanobody that helps CAR-T cells resist immune suppression within the tumor microenvironment. This immune suppression is one of the key challenges that has limited CAR-T effectiveness in solid tumors.
Manufacturing Advantages
BZDS1901 can be produced in under two days, compared to 9-10 days for most CAR-T therapies. This is achieved using a proprietary mRNA-delivered enzyme rather than expensive viral vectors, resulting in a more cost-efficient and scalable production process.
Faster manufacturing could improve patient access by reducing the wait time between cell collection and treatment infusion. For patients with fast-growing cancers, this shorter timeline may be clinically meaningful.
Development Plans
Under the collaboration agreement, AdCella will:
- Establish CAR-T manufacturing capabilities in Australia
- Conduct a phase 1 clinical trial in up to 18 patients
- Invest US$22-31 million over the next four years
SHcell retains commercialization rights in China, while AdCella holds rights for all markets outside greater China. The companies will share net economic proceeds from any commercialization on a 60/40 basis in favor of AdCella.
Market Context
The global mesothelioma drug market is projected to reach $12.2 billion by 2034. Several CAR-T programs are under development for mesothelioma, including SynKIR-110, which received FDA Fast Track designation in April 2023.
The partnership represents what the companies describe as an “East to West” strategy. Leveraging scientific innovation from China alongside Australian clinical and manufacturing capabilities.
What This Means for Patients
BZDS1901 remains in early clinical development, and larger trials will be needed to confirm these initial results. However, the response rate data suggests it could eventually offer another treatment option for patients who have progressed on standard therapies.
Patients interested in CAR-T therapy options should discuss clinical trial eligibility with their oncologist or a mesothelioma specialist. The phase 1 trial is expected to begin recruiting once manufacturing capabilities are established in Australia.
BZDS1901 remains in early clinical development. Larger trials will be needed to confirm these initial results. Patients interested in CAR-T therapy should discuss clinical trial eligibility with their oncologist or mesothelioma specialist.
References
Biotech Dispatch. AdAlta and SHcell launch cancer collaboration to progress breakthrough CAR-T therapy.
https://biotechdispatch.com.au/news/adalta-and-shcell-launch-cancer-collaboration-to-progress-breakthrough-car-t-therapy
SmallCaps. AdAlta inks major CAR-T deal for global development outside China.
https://smallcaps.com.au/article/adalta-inks-major-car-t-deal-for-global-development-outside-china
Reader Q&A
Frequently Asked Questions
What is BZDS1901 and how does it work?
BZDS1901 is a first-in-class CAR-T cell therapy that targets mesothelin, a protein highly expressed on mesothelioma cells. What distinguishes it from other CAR-T approaches is its “armored” design. It includes a PD-1-blocking nanobody that helps CAR-T cells resist immune suppression within the tumor.
How do these results compare to current treatments?
The 63.5% response rate is significantly higher than standard treatments for mesothelioma, which typically yield response rates of 11-29%. Additionally, 73% of patients survived more than 12 months, compared to typical median survival of 8.4-8.7 months with standard therapies.
When will this treatment be available?
BZDS1901 is still in early development. AdCella plans to conduct a phase 1 clinical trial in up to 18 patients in Australia, with US$22-31 million investment over the next four years. The treatment is not yet available outside clinical trials.
Why has CAR-T been difficult for solid tumors like mesothelioma?
While CAR-T has transformed treatment for some blood cancers, solid tumors create immune-suppressive environments that have limited CAR-T effectiveness. BZDS1901’s “armored” design with a PD-1-blocking nanobody is specifically engineered to overcome this challenge.
How many chemo treatments does it take to shrink a tumor?
Chemotherapy typically requires at least two cycles, or 6 to 9 weeks, to shrink tumors, as assessed by oncologists before evaluating response. The number of cycles for people with cancer, including mesothelioma, generally ranges from 4 to 8, with a full course lasting 3 to 6 months depending on cancer type, stage, overall health, and treatment response. Visible tumor shrinkage often appears after a couple of cycles, though complete responses may take months or longer. Cycle lengths vary, such as weekly, every 2 to 3 weeks, or monthly, to balance efficacy and recovery.
What new cancer drug has a 100% success rate?
Dostarlimab (Jemperli), a PD-1 inhibitor immunotherapy, achieved 100% clinical complete remission in all 42 people with mismatch repair-deficient (dMMR) locally advanced rectal cancer who completed treatment in a phase 2 trial at Memorial Sloan Kettering Cancer Center. No evidence of disease was detected via imaging, endoscopy, and biopsy after six months of treatment, with sustained responses up to four years and minimal side effects; none required chemotherapy, radiation, or surgery. These results were updated in June 2024 at ASCO, but dostarlimab applies only to this rare dMMR rectal cancer subset (5-10% of cases), not other cancers or tumor types ,. Larger trials are ongoing to confirm durability and broader applicability (NCT02997228 on ClinicalTrials.gov).
What is the success rate of CAR T-cell therapy?
CAR T-cell therapy success rates vary significantly depending on the cancer type and how success is measured. For blood cancers like lymphoma and leukemia, initial response rates range from 50% to 90%, with complete response rates between 40% and 86%. However, long-term durable remission is lower, with approximately 30% to 40% of people with lymphoma achieving lasting remission without additional treatment , and five-year overall survival around 32% in one study of relapsed or refractory large B-cell lymphoma. In pediatric patients with B-cell acute lymphoblastic leukemia, complete remission rates exceed 80%, though only about 50% maintain long-term event-free survival. Success depends on cancer type, disease stage, patient age, and whether responses are measured as initial response, complete remission, or durable long-term survival.
Can stage 4 cancer be cured with immunotherapy?
Immunotherapy has significantly improved survival outcomes for people with stage 4 cancer, particularly in melanoma, non-small cell lung cancer, and certain colorectal cancers. However, “cure” remains rare. For example, people with advanced non-small cell lung cancer and high PD-L1 expression achieve a 5-year overall survival rate of 23.2% with immunotherapy versus 15.5% with chemotherapy alone. In colorectal cancer with microsatellite instability-high tumors, 60-70% of people respond to immunotherapy. While some people with stage 4 disease have achieved remission or disease-free status, immunotherapy functions primarily as a long-term disease management strategy rather than a cure for most cancer types. Treatment eligibility depends on tumor characteristics, genetic markers, and protein expression, making individual outcomes highly variable.