Status:
ACTIVE_NOT_RECRUITING
Clinical Study on the Safety and Efficacy of CAR-T/CAR-NK Cells in the Treatment of Recurrent Refractory or Unresectable Solid Tumors
Lead Sponsor:
The Second Hospital of Shandong University
Conditions:
Safety and Efficacy of Cellular Drugs, Objective Response Rate of Subjects, Etc
Eligibility:
All Genders
15-80 years
Phase:
EARLY_PHASE1
Brief Summary
To investigate the safety and efficacy of CAR-T/CAR-NK cells in patients with recurrent or unresectable solid tumors, including pancreatic cancer, prostate cancer, breast cancer, glioma, etc
Detailed Description
To investigate the safety and efficacy of CAR-T/CAR-NK cells in patients with recurrent or unresectable solid tumors, including pancreatic cancer, prostate cancer, breast cancer, glioma, etc. The stu...
Eligibility Criteria
Inclusion
- Recurrent or unresectable solid tumors (including pancreatic, prostate, breast, glioma, etc.).
- Age over 15 and under 80.
- KPS≥50 or ECOG score ≤2 and expected survival greater than 3 months.
- 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.
- The absolute number of neutrophils was \> 1.0x109 /L.
- Absolute number of platelets \> 50x109 /L.
- Absolute number of lymphocytes ≥ 0.2x109 /L.
- ALT/AST \< 3 times normal value.
- Total bilirubin \< 1.5mg/dl.
- Creatinine \< 2.5mg/dl, or creatinine clearance ≥60 mL/min/1.73 m2.
- The ejection fraction of heart ≥ 45%, echocardiography examination centerless fluid, electrocardiogram normal
- Blood oxygen saturation ≥92% under normal environment.
- 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.
- Volunteer to participate in this experiment and sign the informed consent.
Exclusion
- 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.
Key Trial Info
Start Date :
March 21 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06572956
Start Date
March 21 2024
End Date
March 1 2025
Last Update
August 27 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Shandong Province
Jinan, Shandong, China, 250000