CAR‑T cell therapy has already changed the outlook for several blood cancers, delivering long remissions for some people after other options failed. For solid tumors, progress has been slower – until now. In 2025, China’s regulator accepted a New Drug Application (NDA) for a CAR‑T targeting CLDN18.2 in advanced gastric and gastroesophageal junction (GEJ) cancer. NDA acceptance is not approval, but it’s a milestone: regulators are formally reviewing a therapy built for a solid‑tumor antigen, a step many in oncology have anticipated.
What is CLDN18.2 – and why it matters
Claudin 18.2 is a tight‑junction protein that is abnormally present on many gastric cancers (and some pancreatic cancers). A CLDN18.2‑directed CAR‑T is engineered to find that protein, lock onto it, and trigger an immune attack. For patients and families, the clear takeaway is biomarker testing. If gastric/GEJ cancer is involved, asking about CLDN18.2 status may open doors to trials now and, if approvals occur in your region later, to next‑generation options.
What “NDA acceptance” means (and doesn’t)
When an NDA is accepted, regulators have agreed to review the dossier. Final approval still depends on safety and efficacy. Even so, acceptance usually signals a mature evidence package. Public summaries around this program describe randomized data showing a progression‑free survival signal over commonly used options in heavily pretreated disease. For a hard‑to‑treat cancer with limited choices, that is meaningful and helps set the stage for global conversations and future submissions.
What patients can expect if solid‑tumor CAR‑T expands
Timeline & steps.
Typical CAR‑T care involves:
- Leukapheresis to collect T cells
- Engineering and expansion in a specialized lab
- Reinfusion after a short conditioning regimen.
It takes weeks, not days.
Monitoring & side effects
Teams watch for early effects such as fever or low blood pressure; most centers follow standardized playbooks to manage these events safely.
Responses & durability
Some people respond quickly; others need time as the immune response builds. Durability varies with tumor biology and prior therapies, so regular scans and labs are important.
Where does this leave other solid tumors – especially brain cancer?
For glioblastoma, CAR-T remains investigational. Researchers are working on antigen selection, resistance, and delivery across the blood-brain barrier. For a broader view of how cellular immunotherapies compare, see ATACK vs. CAR T-cell: A Comprehensive Comparison of Advanced Cancer Treatments. In parallel, approaches like oncolytic viruses and checkpoint-blockade combinations are also advancing in brain tumors and may eventually be layered with cellular therapies in carefully designed trials.
Myths vs. facts (quick reality check)
- Myth: “NDA acceptance means it’s approved everywhere.”
Fact: It means formal review in that country; timing and decisions vary by region. - Myth: “CAR‑T is a single infusion and you’re done.”
Fact: The process includes collection, manufacturing, conditioning, infusion, and follow‑up – a multi‑week journey. - Myth: “Side effects are always severe.”
Fact: Side effects can be serious, but many cases are manageable with established protocols.
Questions to bring to clinic
- Has my tumor been tested for CLDN18.2 or other actionable targets?
- If a CAR‑T option becomes available, what’s the manufacturing timeline, and how would we manage symptoms while we wait?
- Are there combination trials – for example, CAR‑T plus checkpoint inhibitors – that match my situation and location?
Where experienced navigation helps
Advanced immunotherapies are easier to access through experienced centers with strong clinical‑trial networks. Biotherapy International focuses on cancer immunotherapy, helping patients understand where cutting‑edge strategies – like viral therapies for brain tumors – could fit alongside standard care. For help aligning expectations and logistics, review the coordination role described on the team page for Arthur Portnoy: https://ibiotherapy.com/our-team/arthur-portnoy/
Learn more about programs at https://ibiotherapy.com/.
Bottom line
A first solid‑tumor CAR‑T filing shifts the conversation from “if” to “how soon and where next.” It doesn’t flip global care overnight, but it encourages broader investment in solid‑tumor cell therapies – including thoughtful combinations that could benefit patients in the coming years.
