Breast Cancer, Gastrointestinal Cancer, Gynecologic Cancer, Lung Cancer, Solid Tumor
Conditions
Keywords
Adoptive cell therapy, Tumor Infiltrating Lymphocytes
Brief summary
A clinical trial to assess the safety and efficacy of engineered Tumor Infiltrating Lymphocytes (TIL) for the treatment of Advanced Malignant Solid Tumors
Interventions
BIOLOGICALEngineering 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.
Sponsors
Shanghai Juncell Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximal Tolerance Dose | Up to Day 28 |
| Dose Limiting Toxicity | Up to Day 28 |
| Adverse Events | Maximum 360 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease Control Rate | Every 6 weeks for 12 months | Evaluate the efficacy endpoints of DCR by the investigator with RECIST v1.1 and iRECIST |
| Overall Survival | Every 6 weeks for 12 months | Evaluate the efficacy endpoints of OS by the investigator with RECIST v1.1 and iRECIST |
| Quality of Life Assessment | Every 6 weeks for 12 months | Evaluate with EORTC QLQ-C30 |
| Progression-Free Survival | Every 6 weeks for 12 months | Evaluate the efficacy endpoints of PFS by the investigator with RECIST v1.1 and iRECIST |
| Objective Response Rate | Every 6 weeks for 12 months | Evaluate the efficacy endpoints of ORR by the investigator with RECIST v1.1 and iRECIST |
| Duration of Response | Every 6 weeks for 12 months | Evaluate the efficacy endpoints of DoR by the investigator with RECIST v1.1 and iRECIST |
Countries
China
Contacts
Primary ContactHuajun Jin, PhD
Backup ContactXiaohua Wu, Phd
Outcome results
None listed