A Phase I Study to Evaluate the Safety and Efficacy of Engineering Tumor Infiltrating Lymphocytes Injection (GC203 TIL)in Patients With Advanced Malignant Solid Tumors

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• 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.

Locations
Other Locations
China
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Contact Information
Primary
Huajun Jin, PhD
clinicaltrials@juncell.com
+8621-69110327
Backup
Xiaohua Wu, Phd
Wu.xh@fudan.edu.cn
+862165675209
Time Frame
Start Date: 2024-05-29
Estimated Completion Date: 2027-05-01
Participants
Target number of participants: 18
Treatments
Experimental: Treatment Arm
Engineering Tumor Infiltrating Lymphocytes Injection (GC203 TIL)
Related Therapeutic Areas
Sponsors
Leads: Shanghai Juncell Therapeutics

This content was sourced from clinicaltrials.gov

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