Status:
WITHDRAWN
Mesothelin-targeted CAR-T Cells as a Neo-adjuvant Treatment in Patients With Resectable Pancreatic Cancers: a Feasibility Study
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
Pancreatic ductal adenocarcinoma (PDAC) is a cancer of grave prognosis, with only about 10% of patients alive at 5 years after diagnosis. Primary surgical resection is feasible in about 10-15% of pati...
Detailed Description
In the management of patients with PDAC, the role of neoadjuvant therapy is less certain. Neoadjuvant therapy for pancreatic cancer can in theory control early systemic spread and improve rate of R0 r...
Eligibility Criteria
Inclusion
- Patients with histologically confirmed pancreatic cancer planned for curative resection.
- Age 18 to 70 years old
- Measurable tumors according to RECIST 1.1s
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- A sufficient number of T cells taken through lymphopheresis (CD3+ T cells\>1x109).
- Patients with preserved organ function as evidenced by
- Haematological: Hemoglobin ≥ 8g/dL; Platelet ≥ 75×109/L; INR≤1.5; Absolute neutrophil count (ANC) ≥ 1.5
- ×109 /L; Absolute lymphocyte count ≥ 0.4×109 /L
- Renal: Creatinine \< 1.5 upper limit normal (ULN) mg/dL or Creatinine clearance ≥40 ml/min
- Bilirubin \<1.5 ULN μmol/L; Alanine Aminotransferase (ALT) \<3 IU/L; Albumin ≥30 g/L
- Willing and able to provide written, signed informed consent
- Sexually active subjects must be willing to use an acceptable method of contraception such as double barrier contraception during treatment and for 12 months after the last dose
- Females of childbearing potential must have a negative serum pregnancy test at screening and willing to have additional pregnancy tests during the study.
- Females considered non-childbearing potential include those who have been in menopause for at least 1 year or had tubal ligation at least 1 year prior to screening, or who have had total hysterectomy
Exclusion
- Patients with AIDS
- Patients with serum HBsAg positive
- The patient has an active or uncontrolled infection.
- Subjects with severe heart, brain, liver, kidney or hematopoietic diseases, or psychosis who are not suitable for surgical resection
- In the first evaluation experiment, expansion ability of T cells activated by Cluster of Differentiation (CD) CD3/CD28 magnetic beads is less than 5 times.
- Pregnant or lactating women
- Those who participate in other clinical trials.
- History of chronic pancreatitis or Immunoglobulin G4 (IgG4) disease
- Patients who require splenectomy during surgery for pancreatic cancer. History of second malignancy except for any of the following:
- ( • Carcinoma in situ of the cervix or non-melanoma skin cancer ) ( • A cancer diagnosed and curatively treated ≥5 years prior to leukapheresis with no subsequent evidence of cancer recurrence )
- History of or waiting for organ transplantation, including liver transplantation
- Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation
Key Trial Info
Start Date :
February 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 2 2026
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06054308
Start Date
February 2 2024
End Date
August 2 2026
Last Update
August 21 2024
Active Locations (1)
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1
Endoscopy Centre, Prince of Wales Hospital
Shatin, N.T., Hong Kong