China’s latest Car-T bets revealed
First-in-human listings bring a bispecific and yet another in vivo Car-T.
First-in-human listings bring a bispecific and yet another in vivo Car-T.
Three new Chinese phase 1 study initiations, as revealed in the latest listings on the clinicaltrials.gov database, have illustrated three intriguing trends in the development of Car-T therapies.
One involves work in multiple myeloma to develop multispecific projects, in this case BCMA and GPRC5D, where there’s been separate interest in the T-cell engager arena; another is using a protein commonly targeted by lupus therapies for the development of anticancers. But perhaps the hottest current trend is in vivo Car-T, and here a new week has brought yet another clinical-stage entrant.
That in vivo Car-T is Suzhou Immunofoco’s IMV101, an anti-CD19 Car delivered using a lentivirus. At last year’s ASH conference IMV101 was featured in a preclinical poster, which claimed that it demonstrated high specificity of T-cell transduction and potent in vitro and in vivo antitumour activity, and the phase 1 study began shortly afterwards.
IMV101 thus joins Shenzhen Genocury’s JY232, Create’s MT-304, PersonGen’s LV009 and Legend’s LVIVO-TaVec200 among in vivo cell therapies that have recently entered clinical trials (though Create’s isn’t a Car-T therapy). The total number of clinical-stage in vivo Car-T projects now appears to stand at 17.
Multispecifics
Multiple myeloma therapy has for some time been turning towards multispecifics, and the latest to enter clinical trials is O&D’s O&D-001, an ex vivo Car-T therapy hitting BCMA and GPRC5D.
This particular dual-target approach has seen Johnson & Johnson advance ramantamig, Innovent advance IBI3003, and AbbVie take out an option on Simcere’s SIM0500. However, these are all T-cell engagers, and are technically trispecific on account of their CD3 targeting. Perhaps the most important anti-BCMA x GPRC5D Car-T therapy is Bristol Myers Squibb’s BMS-986453.
Recently disclosed first-in-human studies*
| Project | Mechanism | Company | Trial | Scheduled start |
|---|---|---|---|---|
| TGI-5 | Undisclosed MAb | TG ImmunoPharma | Solid tumours, +/- Opdivo | 12 Jun 2025 |
| SWA1211 | HPK1 inhibitor | StoneWise | Solid tumours | 13 Jun 2025 |
| O&D-001 | BCMA x GPRC5D Car-T | O&D BioTechnology | R/r multiple myeloma | 28 Oct 2025 |
| BC2027 | GPC3 ADC | BioCity Biopharma | Solid tumours | 24 Nov 2025 |
| Sapu003 (deciparticle everolimus) | mTOR inhibitor | Oncotelic Therapeutics | mTOR-sensitive solid tumours | 15 Dec 2025 |
| IMV101 | CD19 Car-T (in vivo) | Suzhou Immunofoco | R/r B-cell non-Hodgkin’s lymphoma | 29 Dec 2025 |
| CGT4255 | EGFR-sparing pan-HER2 inhibitor | Cogent | HER2-mutant or +ve solid tumours | 30 Dec 2025 |
| Unnamed | BAFF Car-T | Topcel-KH | CD19-ve/relapsed B-cell lymphoma | Jan 2026 |
| ADCE-B05 | Undisclosed ADC | Adcendo | Solid tumours | 28 Feb 2026 |
| TPD3310 | cMet degrader | Taibidi Pharmaceutical | Solid tumours | 1 Mar 2026 |
Note: *these projects were first listed on the clinicaltrials.gov database between 23 and 29 Jan 2026.
In lupus therapy a popular target is the B-cell survival protein BAFF, which separately has attracted a few companies to develop anticancer Car-Ts, including Pepromene with PBM-CT01.
They are now being joined by an unnamed Car-T therapy originated by Jiangsu Topcel-KH Pharmaceutical. The Chinese company appears to have one other oncology project in development, the anti-PD1 armoured anti-CD19 Car-T RD009, in addition to cell therapies for non-cancer indications.
Other interesting mechanistic approaches newly into human trials include Cogent’s small-molecule pan-HER2 inhibitor CGT4255. This is no ordinary anti-HER2 project, however, its AACR 2025 poster describing its ability to spare EGFR, and thus avoid EGFR-related toxicities, as well as to cross the blood-brain barrier.
Meanwhile, StoneWise is advancing the HPK1 inhibitor SWA1211, which appears to be its first clinical-stage asset. The industry pipeline of clinical HPK1 inhibitors is broad, including two molecules from BeOne (BGB-26808 and BGB-15025), and Nimbus’s NDI-101150. But Pfizer discontinued PF-07265028 in 2023.
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