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clinical study of the gene modified autologous T cells targeted chimeric antigen receptor effect on advanced malignant tumors

clinical study of the gene modified autologous T cells targeted chimeric antigen receptor effect on advanced malignant tumors

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800016276
Enrollment
Unknown
Registered
2018-05-24
Start date
2018-07-01
Completion date
Unknown
Last updated
2018-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

advanced malignant tumors

Interventions

Sponsors

Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: Patients who met the inclusion criteria included those enrolled in the malignant tumors who did not have a valid treatment option, and who had a limited prognosis (less than two years of survival) using the currently available treatment interventions: 1. Patients with malignant tumors aged 18-70 years, and there is no feasible effective treatment; 2. The sample of pancreatic cancer was positive for mesothelin; 3. Have received at least first-line chemotherapy regimen (no limit to the specific chemotherapy regimen) and at least 4 weeks from the last chemotherapy session; 4. Study expected survival after first dose of >12 weeks; 5. There is at least one target lesion that can be assessed by imaging (=10mm); 6. ECOG performance status score 0-1; 7. Have sufficient venous access for apheresis or venous blood collection, and there are no other hemolytic separation contraindications; 8. WBC=2.5×10^9/L, plt=100×10^9/L, HB=9.0g/dl, MID=1.5×10^9/L, LY=0.47×10^9/L LY%=15%; 9. Serum Alb=30g/L; 10. Serum lipase and amylase 2.5ULN, AST and ALT <ULN; 13. Serum total bilirubin =1.5ULN; 14. PT: INR<1.7, PT<(ULN+4)s; All laboratory test results should be within the above-mentioned stable range and there is no continuous supportive treatment.

Exclusion criteria

Exclusion criteria: Patients who meet any of the following criteria cannot be selected for this study: 1. CAR positive T cells 300 mg/day; clopidogrel, measurement >75 mg/day); 13. Four weeks before the start of the study, radiochemotherapy or use of targeted antitumor drugs for the study of the disease; 14. Major surgery or significant trauma within the first 4 weeks of the study (blood sampling), or expected major surgery during the study; 15. Researchers evaluate that patients are unable or unwilling to comply with the requirements of the study protocol.

Design outcomes

Primary

MeasureTime frame
T lymphocyte subsets;meso-CAR-T cell;Tumor burden;Karnofsky;

Secondary

MeasureTime frame
TTP;DCR;PFS;OS;CRS;

Countries

China

Contacts

Public ContactShen Zan

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

sshenzzan@vip.sina.com+86 18930177014

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026