Clinical Study on the Safety and Efficacy of CAR-T/CAR-NK Cells in the Treatment of Recurrent Refractory or Unresectable Solid Tumors

Launched by THE SECOND HOSPITAL OF SHANDONG UNIVERSITY · Aug 26, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a type of treatment called CAR-T/CAR-NK cell therapy for patients with certain types of solid tumors that are either recurrent (coming back after treatment) or cannot be surgically removed. The tumors being examined include pancreatic cancer, prostate cancer, breast cancer, and glioma, among others. The main goal is to see how safe and effective this treatment is for patients aged 15 to 80 who meet specific health criteria, such as having a certain level of physical ability and no severe health issues that would prevent them from participating.

To be eligible for this trial, patients need to have solid tumors that cannot be treated with standard methods, and they must be in relatively good health, meaning they can expect to live for at least three more months. Participants will undergo a procedure to collect their immune cells, which will then be modified and reintroduced into their bodies to help fight the cancer. It's important to note that the trial is currently active but not recruiting new participants, so no new patients can join at this time. If you or a loved one are considering participation in future trials, it’s crucial to discuss any current medications or health conditions with a healthcare provider to ensure safety and suitability for such studies.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Recurrent or unresectable solid tumors (including pancreatic, prostate, breast, glioma, etc.).
• • 2. Age over 15 and under 80.
• • 3. KPS≥50 or ECOG score ≤2 and expected survival greater than 3 months.
• • 4. No systemic therapy (except systemic immune checkpoint suppression or activation therapy) for at least 2 weeks or at least 5 drug half-lives (whichever is shorter) prior to apheresis.
• • 5. The absolute number of neutrophils was \> 1.0x109 /L.
• • 6. Absolute number of platelets \> 50x109 /L.
• • 7. Absolute number of lymphocytes ≥ 0.2x109 /L.
• • 8. ALT/AST \< 3 times normal value.
• • 9. Total bilirubin \< 1.5mg/dl.
• • 10. Creatinine \< 2.5mg/dl, or creatinine clearance ≥60 mL/min/1.73 m2.
• • 11. The ejection fraction of heart ≥ 45%, echocardiography examination centerless fluid, electrocardiogram normal
• • 12. Blood oxygen saturation ≥92% under normal environment.
• • 13. Women of childbearing age who had a negative urine pregnancy test before dosing began and agreed to take effective contraception during the trial until the last follow-up visit.
• • 14. Volunteer to participate in this experiment and sign the informed consent.
• Exclusion Criteria:
• • 1) Those who are expected to survive less than 3 months. 2) Patients whose disease progression was so rapid that a complete treatment cycle could not be ensured at the time of enrollment as determined by the investigator.
• • 3) Patients with primary tumors other than melanoma skin cancer (unless cured for more than 3 years).
• • 4) Patients with infections including fungal, bacterial, viral or other uncontrolled infections or those requiring level 4 isolation.
• • 5) HIV, HBV, HCV positive patients. 6) Patients with central nervous system diseases including stroke, epilepsy, dementia or autoimmune central nervous system diseases.
• • 7) Myocardial infection, cardiac angiography or stenting, active angina pectoris or other significant clinical symptoms, or cardiogenic asthma or cardiovascular plasma cell infiltration in the 12 months prior to enrollment.
• • 8) Those who are receiving anticoagulation therapy or have severe coagulation dysfunction.
• • 9) The drug treatment that the patient is receiving will affect the safety and efficacy study of this project according to the judgment of the investigator.
• • 10) Patients with allergy or history of allergy to the biologics used in this project.
• • 11) Pregnant or lactating women. 12) Systematic use of systemic or systemic steroid drugs within 2 weeks prior to treatment (except those who have recently or currently used inhaled steroids).
• • 13) The efficiency of T cell transduction by replication-deficient lentivirus was less than 30%, or the ability to expand in response to CD3 / CD28 costimulatory signals was insufficient (\<5 times).
• • 14) Those who have other uncontrolled diseases that the researchers consider unsuitable for enrollment.
• • 15) Any situation that the investigator believes may increase the risk to the subject or interfere with the test results.
• • 16) Patients who are also participating in other clinical studies.