In June 2026 China approved CT041, sold as 恺力美, the first CAR-T therapy anywhere in the world approved for a solid tumor. For patients the approval settled one question and opened a harder one: not whether the treatment works, but who should receive it, and at what point in their illness.
Professor Lu Ming, of the Department of Gastrointestinal Oncology at Peking University Cancer Hospital and Beijing Gaobo Hospital, took up that question in a live forum broadcast by Gaobo Medical Forum on 30 October 2026. His answers were unusually practical: which patients fit the current label, why waiting until the last line may be the wrong instinct, what to test for before asking about any trial, and which other immune platforms are worth watching.
The interview at a glance
Approved today: CT041, targeting Claudin18.2, for Claudin18.2-positive and HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma after at least two prior lines.
Under study: sequential use after first-line treatment, adjuvant use after surgery, and targets beyond Claudin18.2 including GPC3, GUCY2C and EpCAM.
Also in development: TCR-T, tumour-infiltrating lymphocyte therapy and personalised mRNA vaccines, all investigational.
The Approved Product, and Who It Fits
Who can receive solid-tumor CAR-T today?
The label is narrow, and it is worth stating precisely. CT041 targets Claudin18.2 and is approved for advanced gastric or gastroesophageal junction adenocarcinoma that is Claudin18.2-positive and HER2-negative, in patients who have already failed at least two lines of treatment.
Why that population was chosen is not hard to see. Once gastric cancer reaches the third line, the list of effective drugs is short and the response rate to conventional chemotherapy is low. In the clinical data, Claudin18.2 CAR-T produced better disease control than standard later-line chemotherapy, and for a subset of patients the time spent free of progression was substantially longer.
The second advantage is tolerability. Across the trials and the treatment that has followed approval, cytokine release syndrome has been manageable, the risk of neurotoxicity appears low, and patients have generally tolerated the infusion well. For a group that has already been through several lines of treatment, that matters as much as the response rate.
What is not yet solved is depth and durability. A meaningful share of patients achieve disease control rather than disappearance of disease, and how to push the response deeper and make remissions last longer remains the central research question.
The Case for Treating Earlier
Should a patient wait until the last line of treatment?
Waiting has a cost that is easy to underestimate. In advanced gastric cancer, and especially where the peritoneum is involved, progression can bring ascites, bowel obstruction or biliary obstruction. Several lines of chemotherapy, targeted therapy and immunotherapy also wear down performance status and immune function, which affects how well a patient tolerates CAR-T and, just as importantly, the quality of the T cells collected and their activity once manufactured.
The approved indication is for later-line patients. But two earlier strategies are already in clinical trials, and both rest on the same logic: use the treatment while the patient is fitter and the tumour burden is smaller.
Sequential CAR-T after first-line treatment
The tumour is reduced first with chemotherapy plus immunotherapy or a targeted agent, and CAR-T is then used to clear what remains. T cells are collected before chemotherapy begins or early in the course, manufactured and stored, then reinfused at the right moment once the earlier treatment is complete. Collecting early preserves T-cell fitness, and holding the infusion until tumour burden is lower gives the cells a better setting in which to work.
Adjuvant CAR-T after surgery
Some patients have the visible tumour removed and still relapse, because microscopic disease remains behind. The question under study is whether CAR-T given after adjuvant chemotherapy can clear that residual disease and lower the risk of recurrence.
Neither strategy has yet been shown to extend long-term survival, and which patients benefit most is still unknown. What the trials are testing is a hypothesis about timing, not a new drug.
Targets Beyond Claudin18.2
What other targets are being studied?
GPC3 in liver cancer is one of the more active areas, and some gastric tumours express it as well. GUCY2C is being pursued in colorectal cancer, and EpCAM and several other targets are in earlier-stage work. Most of these programmes are still early; approval and routine clinical use remain a long way off.
The Tests That Decide Everything
What should a patient be tested for?
Knowing that a target exists matters less than testing the right markers for your own cancer. In gastric cancer the usual panel covers HER2, PD-L1, mismatch repair status, Epstein-Barr virus and Claudin18.2, and FGFR2b, MET and EGFR are attracting increasing attention. Physicians tailor the panel to map the tumour's molecular profile and to judge whether a targeted drug, an antibody-drug conjugate or a clinical trial is the better fit.
For anyone considering a CAR-T trial, the order of operations matters. First establish whether a trial exists for your cancer type, then test according to that protocol's entry criteria. Doing it the other way round generates tests and expense that the trial never required.
Beyond CAR-T: TCR-T, TIL and mRNA Vaccines
Three other immune strategies are moving in parallel, and each answers a limitation that CAR-T carries into solid tumours.
TCR-T
T cells engineered to carry a T-cell receptor. Where CAR-T recognises antigens displayed on the tumour cell surface, TCR-T reads peptides from inside the cell that are presented by HLA molecules, which opens targets CAR-T cannot reach directly. Work on KRAS-mutant tumours is being watched closely, with KRAS G12V a leading direction; it may offer an option for some colorectal and other KRAS-mutant solid tumours, though it usually requires a specific HLA match.
Tumour-infiltrating lymphocyte therapy
Lymphocytes with antitumour activity are taken from the patient's own tumour, expanded outside the body and reinfused. Many centres are running trials in this area; the questions that remain are toxicity and tolerability in a patient population that has often been heavily pretreated.
Personalised mRNA vaccines
Rather than engineering cells, these vaccines teach the patient's own immune system to recognise specific tumour antigens. A major line of work is adjuvant use, aiming to reduce recurrence in solid tumours with a high risk of relapse. Programmes are running in pancreatic and biliary tract cancer, and early signals have been positive, but whether recurrence actually falls and survival improves is still being tested.
What This Means If You Are Considering China
The gate is a pathology report and a treatment history, not interest. Whether a centre can offer anything depends on the biomarker, on how many lines a patient has already received, and on which protocols happen to be open at that moment.
The timing question is the one worth raising early. T-cell collection has to happen while the cells are still fit, which means the conversation belongs with the treating team before several lines of therapy have been exhausted rather than after. For patients considering treatment in China, that conversation is easier to hold alongside the existing oncologist than in place of one.
One caution belongs here. Only CT041 is approved for a solid tumour. Everything else described in this interview is investigational and available, if at all, through a trial whose entry criteria most patients screened will not meet.
This is an interview report, not a treatment recommendation.
The views are those of Professor Lu Ming as expressed in a live broadcast by Gaobo Medical Forum on 30 October 2026, edited for length and clarity and translated for an English-speaking readership. Eligibility for any therapy described here depends on the individual case and on the protocol in force at the treating centre. This article is educational and is not medical advice.
Source: live interview with Professor Lu Ming, Department of Gastrointestinal Oncology, Peking University Cancer Hospital and Beijing Gaobo Hospital, broadcast by Gaobo Medical Forum on 30 October 2026.