Treatment of advanced renal cell carcinoma using CAIX-targeted CAR-T cells
Clinical Study of CAIX-targeted CAR-T Cells in the Treatment of Advanced Renal Cell Carcinoma
This study is testing a new type of immune therapy using specially designed CAR T cells to see if they can help people with advanced kidney cancer feel better and improve their treatment outcomes.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | The Affiliated Hospital of Xuzhou Medical University Academic / other |
| Drugs / interventions | immunotherapy, CAR T, CAR-T, chemotherapy, cyclophosphamide |
| Locations | 1 site (Xuzhou, Jiangsu) |
| Trial ID | NCT04969354 on ClinicalTrials.gov |
What this trial studies
This clinical study evaluates the safety and efficacy of CAR T cells that target carbonic anhydrase IX (CAIX) in patients with advanced renal cell carcinoma. The trial is divided into two phases: Phase 1 focuses on determining the maximum tolerated dose of CAR T cells after pre-treatment with chemotherapy and an anti-CAIX antibody, while Phase 2 administers the optimal dose to assess therapeutic effects. Patients will receive IL-2 injections post-infusion to enhance T cell proliferation. The study aims to provide insights into a novel immunotherapy approach for a challenging cancer.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with advanced or metastatic renal cell carcinoma who have previously undergone targeted therapies or immunotherapies.
Not a fit: Patients with active infectious diseases or those who do not meet the organ function criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new, effective immunotherapy option for patients with advanced renal cell carcinoma.
How similar studies have performed: While CAR-T cell therapies have shown promise in other cancers, this specific approach targeting CAIX in renal cell carcinoma is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or female patients aged from 18 to 70 years old; 2. The patient's ECOG score is ≤ 2; 3. Patients with advanced or metastatic renal cell carcinoma: (1) have received first-line and second-line targeted therapy in the past; (2) Previous immunization with PD-1/L1 and ≤2 regimens; (3) Unable to tolerate targeted therapy or immunotherapy. 4.There are measurable or evaluable lesions; 5.The main tissues and organs of patients function well: 1. liver function: ALT/AST\< 3 times the upper limit of normal value (ULN); 2. Renal function: creatinine \< 220 μmol/L; 3. Lung function: indoor oxygen saturation ≥ 95%; 4. Cardiac function: Left ventricular ejection fraction (LVEF)≥40% 6.Patients or their legal guardians voluntarily participate and sign informed consent. Exclusion Criteria: 1. Infectious diseases (such as HIV, active hepatitis B or C infection, active tuberculosis, etc.); 2. Feasibility assessment and screening showed that the transfection of targeted lymphocytes was less than 10% or the amplification was insufficient (\< 5 times) under the co-stimulation of CD3/CD28. 3. The vital signs are abnormal, and those who cannot cooperate with the examination; 4. Those who have mental or psychological diseases can not cooperate with treatment and efficacy evaluation; 5. Highly allergic constitution or severe allergic history, especially those who are allergic to IL-2; 6. Subjects with systemic infection or severe local infection who need anti-infection treatment; 7. Complicated with dysfunction of heart, lung, brain, liver, kidney and other important organs; 8. Patients with other tumors; 9. Doctors believe that there are other reasons that can not be included in the treatment.
Where this trial is running
Xuzhou, Jiangsu
- Affiliated Hospital of Xuzhou Medical University — Xuzhou, Jiangsu, China (Recruiting)
Study contacts
- Principal investigator: Hailong Li, M.D/Ph.D — The Affiliated Hospital of Xuzhou Medical University
- Study coordinator: Hailong Li, M.D/Ph.D
- Email: Justinlee719@163.com
- Phone: 0086-17798835021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.