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Trial Title:
Engineering Tumor Infiltrating Lymphocytes Injection (GC203 TIL) for the Treatment of Advanced Malignant Solid Tumors
NCT ID:
NCT06375187
Condition:
Solid Tumor
Gynecologic Cancer
Breast Cancer
Gastrointestinal Cancer
Lung Cancer
Conditions: Official terms:
Gastrointestinal Neoplasms
Conditions: Keywords:
Adoptive cell therapy
Tumor Infiltrating Lymphocytes
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Engineering Tumor Infiltrating Lymphocytes
Description:
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.
Arm group label:
Treatment Arm
Other name:
GC203 TIL
Summary:
A clinical trial to assess the safety and efficacy of engineered Tumor Infiltrating
Lymphocytes (TIL) for the treatment of Advanced Malignant Solid Tumors
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaohua Wu, PhD
Phone:
+862164175590
Email:
Wu.xh@fudan.edu.cn
Start date:
May 29, 2024
Completion date:
May 1, 2027
Lead sponsor:
Agency:
Shanghai Juncell Therapeutics
Agency class:
Industry
Source:
Shanghai Juncell Therapeutics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06375187
