CT041 CLDN18.2 CAR-T Cell Therapy for Advanced Gastric, GEJ and Pancreatic Cancer
NCT03874897 (CT041-CG4006) was a landmark multi-center Phase 1 study evaluating CT041 β an autologous anti-CLDN18.2 CAR-T therapy β in patients with CLDN18.2-positive advanced solid tumors who had exhausted prior systemic treatment. Results published in Nature Medicine established CLDN18.2 CAR-T as a clinically viable approach. CancerFax can help you understand the published findings and navigate currently available access pathways.
About This Clinical Trial
Advanced gastric and gastroesophageal junction (GEJ) cancer carries one of the most difficult prognoses in oncology once first-line chemotherapy has failed. Most patients with metastatic gastric cancer live fewer than twelve months after second-line therapy, and options narrow further with each progression. Pancreatic cancer shares a similarly bleak outlook in the refractory setting. For families facing this reality, the need for genuinely new treatment approaches β ones that work through a mechanism distinct from cytotoxic chemotherapy β is urgent.
NCT03874897, internally designated CT041-CG4006, was an open-label, multi-center Phase 1 dose-escalation and dose-expansion study evaluating CT041, an autologous humanized anti-CLDN18.2 chimeric antigen receptor T-cell therapy, in patients with advanced solid tumors confirmed to express CLDN18.2 at IHC β₯2+ intensity in at least 40% of tumor cells. The trial tested CT041 as monotherapy across three dose levels (2.5Γ10βΈ, 3.75Γ10βΈ and 5.0Γ10βΈ cells per infusion), and also explored CT041 in combination with an anti-PD-1 checkpoint inhibitor and as a sequential treatment following first-line chemotherapy.
CLDN18.2 is a gastric-specific isoform of the tight junction protein claudin-18. In healthy adults, it is expressed almost exclusively in the gastric mucosa and is normally buried inside tight junctions β inaccessible to circulating immune cells or antibodies. In gastric, GEJ, and pancreatic cancers, tumor cells lose their structural polarity and CLDN18.2 becomes exposed on the cell surface in large quantities, making it a highly selective target. The humanized anti-CLDN18.2 scFv used in CT041 was designed to improve affinity and reduce immunogenicity compared to earlier murine constructs.
Final results from 98 infused patients (Nature Medicine, 2024) confirmed an ORR of 37.8%, DCR of 75.5%, median PFS of 4.4 months and median OS of 8.4 months β with no grade 3+ CRS and no treatment-related deaths. These results directly informed CARsgen's NDA submission to China's NMPA and the Phase 2 pivotal trial CT041-ST-01.
The primary objective was to determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) of CT041 within 28 days of infusion. Secondary objectives included CAR-T cell pharmacokinetics, adverse event profiling, and anti-tumor efficacy (ORR, DCR, PFS, OS).
Trial at a Glance
The table below summarises key trial facts from the registry. This is not a confirmation of eligibility or a guarantee of access.
Final eligibility is determined only by the trial investigators after reviewing complete medical records.
Treatment Being Studied
CT041 β now known as satricabtagene autoleucel (satri-cel) β is a fully autologous chimeric antigen receptor T-cell therapy targeting CLDN18.2, a tight junction protein that becomes selectively exposed on the surface of gastric, GEJ, and pancreatic tumor cells. Unlike standard chemotherapy that attacks dividing cells broadly, CT041 engineers the patient's own immune T cells to specifically recognize and destroy CLDN18.2-expressing cancer cells.
The treatment process is multi-step and requires an extended stay at the trial center. CT041 was evaluated as a single or multiple intravenous infusion following lymphodepleting conditioning chemotherapy, with certain cohorts also receiving an anti-PD-1 checkpoint inhibitor.
How CT041 works
T cells collected from the patient are genetically engineered using a viral vector to express a chimeric antigen receptor (CAR) that binds CLDN18.2 on the surface of tumor cells. Once infused, these re-engineered cells proliferate in the body, seek out CLDN18.2-positive tumor cells, and kill them through direct cytotoxic mechanisms. The humanized scFv design reduces the risk of immune rejection of the CAR construct itself.
A tumor biopsy specimen is tested by IHC to confirm CLDN18.2 expression at β₯2+ staining intensity in at least 40% of tumor cells. This is a mandatory eligibility requirement.
The patient's own T cells are collected through leukapheresis β a blood filtration procedure taking 3β4 hours at the trial center. Cells are then shipped to CARsgen's GMP manufacturing facility.
Collected T cells are genetically engineered to express the anti-CLDN18.2 CAR and expanded to reach the target dose. Manufacturing typically takes 3β4 weeks.
Before the CT041 infusion, patients undergo conditioning chemotherapy (typically cyclophosphamide and fludarabine) to deplete existing immune cells and create a favorable environment for CAR-T engraftment.
The manufactured CT041 product is infused intravenously. Patients are hospitalized for 2β4 weeks post-infusion for close monitoring of CRS, hematologic changes, and gastric mucosal effects.
Tumor response is assessed by CT or MRI per RECIST v1.1 at defined intervals. CAR-T persistence in peripheral blood is tracked by qPCR over 26 weeks, with long-term survival follow-up up to 15 years.
Primary endpoints: dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) within 28 days. Secondary endpoints: CAR-T pharmacokinetics (qPCR at 26 weeks), adverse events (CTCAE v5.0), ORR, DCR, PFS, OS, duration of response, and 15-year long-term survival monitoring.
Who This Trial May Be For
This trial is now completed. The patient profile below reflects the eligibility criteria used to select participants. Families can use this to assess whether a related CLDN18.2-targeted trial or access pathway may suit their situation.
The trial enrolled patients with pathologically confirmed advanced gastric cancer, GEJ cancer, or pancreatic cancer who had failed at least one prior line of systemic therapy.
Tumor tissue was required to test positive for CLDN18.2 by IHC β specifically β₯2+ staining intensity in at least 40% of tumor cells. This biomarker test must be performed before any CLDN18.2-targeted therapy can be considered.
Eligible patients had already received and progressed on at least one prior line of systemic treatment β the trial targeted patients whose cancer had stopped responding to chemotherapy or other standard therapies.
Patients needed to be ambulatory and capable of normal or light activity β an ECOG score of 0 (fully active) or 1 (restricted but ambulatory), assessed at both leukapheresis and before conditioning.
All patients underwent detailed medical review before enrollment. Patients with prior CAR-T or TCR-T therapy, active brain metastases, uncontrolled infection, or significant organ dysfunction were excluded.
The trial ran at three centers in China. International patients needed to plan for an extended stay β typically 6β10 weeks β covering leukapheresis, manufacturing wait, conditioning, infusion, and inpatient monitoring.
Eligibility Criteria
The criteria below are taken from the published trial protocol. Meeting some criteria does not guarantee enrollment β only the trial investigators can confirm participation after reviewing complete medical records.
check_circleInclusion Criteria β May Be Eligible
- βAged 18 to 75 years, male or female
- βPathologically confirmed advanced gastric cancer, gastroesophageal junction cancer, or pancreatic cancer β failed at least one prior line of systemic treatment
- βTumor tissue positive for CLDN18.2 by IHC (β₯2+ intensity in β₯40% of tumor cells)
- βEstimated life expectancy greater than 12 weeks
- βAt least one measurable or unmeasurable tumor lesion per RECIST 1.1
- βECOG performance status 0β1 within 24 hours prior to apheresis and at baseline
- βSufficient venous access for leukapheresis
- βAdequate organ function (hematologic, hepatic, renal, cardiac) before screening and pre-treatment
- βNegative serum pregnancy test for women of childbearing potential; willingness to use effective contraception for 1 year after last treatment
- βVoluntary written informed consent
cancelExclusion Criteria β May Not Be Eligible
- ΓPregnant or breastfeeding women
- ΓHIV, syphilis (Treponema pallidum), or HCV serologically positive
- ΓUncontrollable active infection, including active tuberculosis or HBV (HBsAg positive, or HBcAb positive with detectable HBV DNA)
- ΓPrior treatment-related toxicities not resolved to CTCAE β€Grade 1 (except alopecia, hyperpigmentation, or other protocol-permitted events)
- ΓSystemic corticosteroid use β₯15 mg/day prednisone equivalent within 7 days prior to apheresis
- ΓKnown allergy to preconditioning agents (cyclophosphamide, fludarabine), tocilizumab, CT041 product components, or Ξ²-lactam antibiotics
- ΓAny prior chimeric antigen receptor-modified T-cell therapy (CAR-T or TCR-T)
- ΓUntreated or symptomatic brain metastases
- ΓLargest target tumor lesion greater than 4 cm
- ΓUnstable or active peptic ulcers or gastrointestinal bleeding
- ΓHistory of or awaiting organ transplantation
- ΓMajor surgery or significant trauma within 4 weeks prior to apheresis
- ΓActive or prior incurable malignancy within the previous 3 years (except in-situ cervical cancer or skin basal cell carcinoma)
Criteria here are illustrative. The trial protocol has its own detailed list. CancerFax can help organize records for review, but only the trial center can confirm participation.
Medical Records and Tests Needed for Review
The documents below are typically required for CLDN18.2 CAR-T case review. CancerFax can help you organize and translate these into a structured medical summary.
How the Trial Process May Work
CLDN18.2 CAR-T therapy involves more preparation steps than most oncology treatments. Families should plan for an extended stay in China across multiple phases of the process.
Submit medical records β pathology, CLDN18.2 IHC, imaging, and treatment history. CancerFax prepares a structured case summary and coordinates a preliminary eligibility assessment with the trial center.
The trial team reviews the submitted case. If the patient meets baseline criteria, formal in-person screening is scheduled at one of the trial sites in China.
The patient travels to China for comprehensive screening β labs, imaging, cardiac assessment, ECOG evaluation, and final biomarker confirmation. Informed consent is obtained before any procedures.
T cells are collected by leukapheresis (3β4 hours). The patient may return home or remain in China during the 3β4 week manufacturing period while cells are engineered at CARsgen's GMP facility.
The patient returns to the trial center for lymphodepleting conditioning chemotherapy, followed by the CT041 infusion. Patients are then hospitalized for 2β4 weeks of intensive post-infusion monitoring.
Tumor response is assessed by RECIST v1.1 imaging at protocol-specified intervals. Follow-up visits continue for up to 26 weeks for CAR-T persistence monitoring, with long-term survival tracking over 15 years.
Potential Benefits
CT041 demonstrated clinically meaningful anti-tumor activity in a heavily pretreated population with very limited effective options. The benefit profile below reflects published Phase 1 data from Nature Medicine (2022 interim; 2024 final).
Interim ORR of 48.6% (N=37) and final ORR of 37.8% (N=98) β substantially higher than the ~10β20% typical in 3rd-line gastric cancer. DCR reached 75.5% in the final dataset.
The entire published trial dataset reported no grade 3 or higher cytokine release syndrome and no treatment-related deaths β a safety record that stands out among solid-tumor CAR-T programs.
CT041 targets CLDN18.2 β a highly selective surface marker in gastric and GI tumors. Patients who test positive at the required threshold gain access to a mechanism not available in standard chemotherapy or current approved biologics.
Participation contributed to the two Nature Medicine publications that established CLDN18.2 CAR-T as a viable approach in solid tumors, directly influencing the global development program for satri-cel.
The published data from this trial formed the basis for the Phase 2 pivotal trial CT041-ST-01, which showed statistically significant PFS and OS benefits over physician's choice (The Lancet, 2025), and for CARsgen's regulatory submissions in China and the US.
Patients received close multi-disciplinary monitoring throughout the trial period β including regular imaging, qPCR-based CAR-T tracking, and structured safety assessments β providing a level of surveillance not available in standard outpatient care.
Not every patient responded to CT041. A trial may or may not directly benefit the individual patient. The data above are population-level outcomes from a research study β they cannot predict individual response.
Risks and Side Effects
CT041 is a CAR-T cell therapy and carries risks inherent to this class. The safety profile observed was notably more manageable than many hematologic CAR-T programs, largely because CLDN18.2 expression in normal tissue is restricted to the buried gastric mucosa.
CRS occurred in approximately 95β97% of patients, but almost all cases were grade 1β2 β fever, fatigue, mild drops in blood pressure β resolving with standard supportive care. No grade 3 or higher CRS was reported across the published cohorts.
Grade 3 or higher reductions in neutrophil, platelet, or red blood cell counts occurred in virtually all patients following the lymphodepleting conditioning chemotherapy. This is expected and managed with transfusions, growth factors, and antibiotics.
8% of patients developed gastric mucosal injury β mostly grade 1β2 erosions or gastritis that resolved with treatment. One patient had grade 3 erosive gastritis that recovered fully. Endoscopic monitoring is typically included in the protocol.
Immune effector cell-associated neurotoxicity syndrome (ICANS) was not observed in any patient in the published trial cohorts β a meaningful safety advantage over CAR-T therapies targeting hematologic antigens.
The combination of lymphodepletion and post-infusion immunosuppression significantly increases bacterial, viral, and fungal infection risk. Prophylactic antimicrobials are standard; patients are monitored closely during inpatient stay and follow-up.
CT041 is an investigational therapy. Long-term effects β including unknown delayed toxicities, secondary malignancies, or off-target effects β may not yet be fully characterised despite 5+ years of follow-up data.
Travel to China, extended stay costs, medical visa uncertainty, possible trial discontinuation, and no guaranteed benefit are all real considerations. These should be weighed carefully with the patient's oncologist and family before committing to the process.
Trial Location and Hospital Information
NCT03874897 was conducted at three academic cancer centers in China. The trial is now closed, but these centers remain active in CLDN18.2-targeted therapy research and related follow-on programs.
International patients considering CLDN18.2-targeted therapy in China typically need a Chinese medical visa (M or F visa category), certified translations of all medical records into Mandarin, accommodation near the hospital in Beijing or Hangzhou for 6β10 weeks, and a dedicated patient coordinator. CancerFax manages all of these logistics and acts as the single point of contact between the patient and the Chinese hospital team.
Costs, Trial Coverage, and Patient Expenses
This trial has concluded. The cost structure below reflects what was typical during the trial period at Chinese academic cancer centers. Families exploring related active programs should contact CancerFax to understand current access and cost arrangements.
CancerFax helps families understand expected cost categories and what is typically covered by the trial or institution. Final confirmation of cost coverage must always come from the trial center directly, in writing, before travel is arranged.
Standard Treatment vs Clinical Trial
For patients with CLDN18.2-positive advanced gastric or GEJ cancer who have failed prior therapy, available second- or third-line options offer limited response rates. CT041 demonstrated a different efficacy and safety profile in this population.
How CancerFax Helps
CancerFax is a specialist cancer-access and patient-navigation platform. We do not treat patients or run clinical trials β we help families understand their options, organize their case, and access the right specialist pathways.
CancerFax structures your full medical file β pathology, IHC results, imaging, treatment history, and labs β into a clean case summary ready for specialist review.
We explain what CLDN18.2 IHC testing involves, identify accredited labs in India, China, and internationally, and help families interpret their results against trial thresholds.
We assess your case against published trial and therapy eligibility criteria, identify gaps, and coordinate preliminary review with relevant Chinese cancer centers.
CancerFax liaises directly with oncology teams at Peking University Cancer Hospital, CARsgen-affiliated centers, and other relevant Chinese institutions on your behalf.
We support medical visa applications, travel planning, certified Mandarin interpretation, and accommodation arrangements near the treatment facility for the full duration.
From first inquiry through treatment and follow-up, CancerFax provides a single point of contact β so families can focus on the patient, not the administrative complexity.
CancerFax does not guarantee trial enrollment, treatment response, or outcome. Our role is to help patients access accurate information and appropriate pathways.
Questions to Ask Before Considering This Trial
If you or your oncologist are considering CLDN18.2-targeted therapy, these questions will help you get the information you need from the trial team or treating specialist.
Frequently Asked Questions
Want to Know If a CLDN18.2 Therapy May Be Relevant?
CancerFax can review your medical records, confirm CLDN18.2 biomarker status, identify currently enrolling related trials, and coordinate with Chinese cancer centers β so you have a clear picture of your options before making any decisions.
The information on this page is for educational and patient-navigation purposes only. It does not replace medical advice, diagnosis, or treatment from a qualified physician. Clinical trial eligibility, enrollment, treatment decisions, and costs are determined only by the trial investigators, hospital, sponsor, and applicable regulations. CancerFax helps patients and families understand options and coordinate case review where appropriate, but does not guarantee trial acceptance, treatment response, or clinical outcome. All clinical decisions must be made in consultation with a qualified, licensed physician with access to the patient's complete medical information.
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Β© CancerFax Β· Specialist cancer access and patient-navigation platform. CancerFax is not a medical institution, hospital, or clinical trial sponsor. Trial details may change; always confirm current eligibility, status, and costs directly with the trial center.