Solid TumorGynecologic CancerBreast CancerGastrointestinal CancerLung Cancer
Investigational drug(s) / intervention(s)
Engineering Tumor Infiltrating Lymphocytes
Engineering Tumor Infiltrating Lymphocytes: A tumor sample is resected from each participant and cultured ex vivo to generate the engineered tumor infiltrating lymphocytes. After lymphodepletion, patients are infused GC203 TIL followed low-dose PD-1 antibody.
Study summary
A clinical trial to assess the safety and efficacy of engineered Tumor Infiltrating Lymphocytes (TIL) for the treatment of Advanced Malignant Solid Tumors
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* 1\. In the opinion of the Investigator, patients must be able to sign the ICF and complete all study-required procedures.
2\. Patients must be ≥18 and ≤75 years of age at the time of consent. 3. Patients with advanced metastatic solid tumors with clear pathological diagnosis have failed standard therapy (standard therapy is defined as existing guidelines and consensus recommended therapy \[including but not limited to chemotherapeutic therapy, radiotherapy, mutation-targeted therapy, immunotherapy, and surgery\]) , including but not limited to gynecological tumors (ovarian cancer, endometrial cancer, cervical cancer), breast cancer, gastrointestinal Cancer, lung cancer.
4\. Patients have feasible tissue areas for tumor resection/puncture to generate GC203 TIL, the total volume of the tissue \> 400mm3, and the lesion has not received local treatment (such as radiotherapy, radiofrequency therapy, oncolytic virus, etc.) or has progressed after local treatment; 5. At least one measurable target lesion before preconditioning, as defined by RECIST1.1.
6\. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
7\. Patients must have an estimated life expectancy of ≥3 months. 8. Patients must have the following hematologic parameters, Coagulation functions and hepatic and renal function:
* Absolute Neutrophil Count (ANC)≥1.0×10\^9/L;
* Absolute Lymphocyte Count(ALC)≥0.5×10\^9/L;
* Platelet≥80×10\^9/L;
* International Normalized Ratio(INR)≤1.5×ULN;
* Activated Partial Thromboplastin Time(APTT)≤1.5×ULN;
* Serum Creatinine (Scr)≤1.5mg/dL (or 132.6μmol/L) or Creatinine Clearance≥60mL/min
* Urinalysis: urine protein less than 2+, or 24-hour urine protein \<1g;
* Alanine aminotransferase(AST/SGOT) ≤3×ULN;
* Alanine aminotransferase (ALT/SGPT) ≤3×ULN;
* Total Bilirubin(TBIL)≤1.5×ULN; 9. Women of child-bearing potential (WCBP), must have a negative serum pregnancy test prior to treatment. All sexually active WCBP and all sexually active male subjects must agree to use effective methods of birth control throughout the study.
10\. Patients must have no contraindications for surgery or biopsy. 11. Patients have good compliance and be able to adhere to research access plans and other protocol requirements.
Exclusion Criteria:
1. Participate in clinical trials of other drugs or biologic therapies within 4 weeks before enrollment;
2. Participants who have had a history of allogeneic T cell therapy; gene engineering autologous cell therapy within 1 years.
3. Patients who have received systemic antitumor therapy within 4 weeks.
4. Patients who have had another primary malignancy within the previous 5 years
5. Patients who have received a live or attenuated vaccination within 28 days prior to the start of treatment
6. Patients with a history of hypersensitivity to any component of the study drugs
7. Patients who are pregnant or breastfeeding.
Primary outcome measure(s)
Maximal Tolerance Dose — Up to Day 28
Dose Limiting Toxicity — Up to Day 28
Adverse Events — Maximum 360 days
Trial sites (1)
Facility
City
Region
Status
Fudan University Shanghai Cancer Center
Shanghai
China
Recruiting
More Shanghai Juncell Therapeutics trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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