Cellular Therapy · Novel Drug
Solid-Tumor CAR-T (CT041 / Kailimei)
World-first solid-tumor CAR-T approved (NMPA)
Typical Duration
Approx. 6–8 weeks
Estimated Cost
Approved product ≈USD 141,000; studies case-based
The world’s first solid-tumor CAR-T (satricabtagene autoleucel) is listed at about CNY 999,000; other solid-tumor CAR-T programs are mainly in clinical studies, with cost structures per the center’s written information.
Why China
Solid-Tumor CAR-T (CT041 / Kailimei)
01World’s first solid-tumor CAR-T approved in China
Satricabtagene autoleucel (CLDN18.2) is approved for advanced gastric/GEJ adenocarcinoma based on the Chinese investigator-led CT041 program — moving solid-tumor CAR-T from concept to clinical reality.
02The world’s richest target pipeline
China runs the world’s densest solid-tumor CAR-T pipeline across CLDN18.2, GPC3 (liver cancer), mesothelin, EGFR and MUC1 targets, offering enrollment opportunities across tumor types.
03Combinations overcoming the microenvironment
To counter the immunosuppressive microenvironment, Chinese teams are exploring CAR-T combined with checkpoint inhibitors, oncolytic viruses and personalized neoantigen strategies to improve infiltration and persistence.
04Next-generation engineering
Next-generation designs — armored CARs secreting cytokines, dual-target constructs and controllable safety switches — have entered clinical studies to improve efficacy while reducing off-tumor toxicity.
Quick Overview
Care Journey
01
Case Review
Submit your records and imaging; receive a written expert assessment and preliminary plan within 48 hours.
02
Plan & Estimate
A multidisciplinary team (MDT) defines your individualized treatment plan with a transparent cost estimate.
03
Travel Preparation
We assist with medical visa, flights and accommodation, and assign a professional medical interpreter.
04
In-Hospital Care
A dedicated coordinator accompanies you through examinations and treatment, bridging all communication.
05
Recovery & Follow-up
Remote follow-up after you return home, with review schedules and medication guidance.
06
Long-term Management
Stay connected with your treating team, with fast-track return visits whenever needed.
Medical Team
Hospitals
Cancer Hospital, CAMS (National Cancer Center)
Beijing · Grade III-A · National Cancer Center
Fudan University Shanghai Cancer Center
Shanghai · Grade III-A · National Regional Cancer Center
Sun Yat-sen University Cancer Center
Guangzhou · Grade III-A · Host of State Key Laboratory
Peking University Cancer Hospital
Beijing · Grade III-A · MOE Key Laboratory
Frequently Asked Questions
How does solid-tumor CAR-T differ from hematologic CAR-T?+
Solid-tumor CAR-T faces three extra challenges: scarcity of specific surface targets, an immunosuppressive microenvironment and inadequate T-cell infiltration. Its efficacy ceiling is currently lower than hematologic CAR-T, but the CLDN18.2 approval proves meaningful clinical benefit is achievable with the right target and population.
Which patients may be considered?+
Approved: CLDN18.2-positive, HER2-negative advanced gastric/GEJ adenocarcinoma after at least two failed lines. Investigational: GPC3-positive liver cancer, mesothelin-positive pancreatic/ovarian cancer, EGFR-positive lung cancer and others, subject to target testing and comprehensive assessment at research centers.
Are the risks the same as hematologic CAR-T?+
CRS and ICANS also occur, but solid-tumor CAR-T adds on-target off-tumor toxicity: CLDN18.2 is also expressed in normal gastric mucosa, so mucosal injury may occur. Centers design monitoring and management protocols based on the target’s tissue distribution.
Process and timeline?+
Similar to hematologic CAR-T: assessment and target testing (1–2 weeks) → apheresis → 2–3 weeks of manufacturing → lymphodepletion → infusion → about 2 weeks of inpatient monitoring → 2–4 weeks of local observation. Total about 6–8 weeks, with a caregiver recommended.
Costs and study options?+
The approved satricabtagene autoleucel is listed at about CNY 999,000 (≈USD 141,000) plus tests and admission; research-stage programs more often have drug and manufacturing covered by the sponsor. Based on target testing we prioritize suitable studies, with all costs confirmed in writing before travel.
Detailed Information
Approved and investigational targets
Approved: CLDN18.2 (satricabtagene autoleucel for advanced gastric/GEJ adenocarcinoma). Investigational: GPC3 (hepatocellular carcinoma — highly prevalent in China with the richest pipeline), mesothelin (pancreatic, ovarian, mesothelioma), EGFR (lung), MUC1, HER2 and others. Target selection considers tumor type, expression intensity and prior therapy, assessed by the research center’s MDT.
Candidate profile and assessment
Basic requirements: pathological confirmation, positive target IHC/molecular testing at protocol thresholds, failure of or lack of standard options, organ function tolerating lymphodepletion and cell therapy, ECOG 0–1. We help organize records and slide testing remotely; after screening, the center advises whether an on-site assessment is warranted.
Treatment process
Weeks 1–2: assessment, target re-verification and apheresis. Weeks 3–5: GMP manufacturing and release. Week 6: infusion after lymphodepletion with about 2 weeks of inpatient monitoring (focused on CRS, ICANS and on-target toxicities such as gastric mucosal injury). Around week 8: local observation after discharge; first response assessment at about 4–6 weeks post-infusion.
Risk profile and management
Beyond CRS/ICANS, solid-tumor CAR-T requires attention to on-target off-tumor toxicity (based on normal-tissue expression of the target), local tumor inflammation, cytopenias and infection. Centers are equipped with ICU support and rescue protocols (tocilizumab, steroids) plus organ-specific monitoring tailored to the target’s expression map. Long-term follow-up covers cell persistence, secondary malignancies and fertility impact.
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