Cell therapies head for the clinic

Cell therapies, including Car-T, Car-NK and engineered T-cell receptor constructs, feature as notable entrants to first-in-human studies, recent entries to the clinicaltrials.gov registry reveal.

That not one but five new Car-NK constructs should now be in clinical trials is especially interesting, given the disappointments that have surrounded earlier work with such approaches. All five are multispecific, belong to Beijing Biotech, and join four other Car-NKs with multiple targets that the Chinese company took into human trials last month.

At that time Beijing advanced two unnamed dual-targeted Car-NK studies. One was against CEACAM5 and GUCY2C, while the other comprised three separate constructs: against mesothelin x EGFR, mesothelin x HER2 and EGFR x HER2. The trials called for each relevant patient population to have tumours expressing the antigens being targeted.

Now come two more trials, involving a further five Car-NK constructs. The first gives pancreatic ductal adenocarcinoma patients anti-mesothelin x MUC1 or Claudin18.2 x MUC1 Car-NK cells, based on prior testing of their tumours for expression of these antigens, and ensuring that these meet positivity thresholds.

In the second trial Beijing will test anti-DLL3 x CD56, DLL3 x GD2 and CD56 x GD2 Car-NK cells in relapsed/refractory small-cell lung cancer. Interestingly, however, this study doesn’t set biomarker expression as an inclusion criterion, only specifying that tumour tissue must be available for antigen profiling by immunohistochemistry for DLL3, CD56 and GD2.

Other targets

In the more traditional Car-T space Gyala Therapeutics is advancing GYA01, a construct against CD84, in a trial enrolling patients with ALL or T-cell leukaemias.

CD84, also known as SlamF5, is an adhesion molecule regulating T-cell activation and B-cell tolerance, and is said to be a promising target in haematological cancers. Despite this, OncologyPipeline reveals a Car-T therapy from BRL Medicine as the only other clinical asset; Slam Biotherapeutics is targeting CD84 with two modalities, and the first, an ADC coded SLM124, is to enter the clinic this year.

The other cell therapy newly into the clinic is Neowise’s NW-301VT, an engineered T-cell receptor against KRAS G12V that incorporates into its design a dominant-negative TGF-β receptor.

KRAS is a key focus for Neowise, which in 2024 advanced into human trials what appears to be a related asset coded NW-301. That project is said to target KRAS G12D and G12V, with engineered TCRs against these proteins, so it’s possible that NW-301VT is a version of one of those. Both assets are restricted to HLA-A*11:01, the HLA type especially prevalent in Asian populations.

Outside cell therapy, Whitehawk Therapeutics is continuing its makeover into an ADC company – it was previously called Aadi Bioscience, and was developing a sirolimus formulation – with the advancement into human trials of HWK-016, which targets MUC16. Whitehawk’s lead, the anti-PTK7 ADC HWK-007, entered phase 1 last December.

And Shouyao Holdings is taking forward SY-9453, a small-molecule inhibitor of MAT2A. This follows endorsements from BeOne and Gilead, which have both bought into China-originated MAT2A inhibitors. 

Recently disclosed first-in-human studies*

Note: *these projects were first listed on the clinicaltrials.gov database between 6 and 18 Mar 2026.