Clinical trial NCT06375187: Engineering Tumor Infiltrating Lymphocytes Injection (GC203 TIL) for the Treatment of Advanced Malignant Solid Tumors
Official title: A Phase I Study on Engineering Tumor Infiltrating Lymphocytes Injection (GC203 TIL) for the Treatment of Advanced Malignant Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Solid Tumor
Gynecologic Cancer
Breast Cancer
Gastrointestinal Cancer
Lung Cancer
Keywords: Adoptive cell therapy
Tumor Infiltrating Lymphocytes
Lead sponsor: Shanghai Juncell Therapeutics
Sponsor class: INDUSTRY
First posted: 2024-04-19
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Maximal Tolerance Dose
timeFrame: Up to Day 28
measure: Dose Limiting Toxicity
timeFrame: Up to Day 28
measure: Adverse Events
timeFrame: Maximum 360 days
Secondary outcomes:
measure: Objective Response Rate
timeFrame: Every 6 weeks for 12 months
measure: Duration of Response
timeFrame: Every 6 weeks for 12 months
measure: Disease Control Rate
timeFrame: Every 6 weeks for 12 months
measure: Progression-Free Survival
timeFrame: Every 6 weeks for 12 months
measure: Overall Survival
timeFrame: Every 6 weeks for 12 months
measure: Quality of Life Assessment
timeFrame: Every 6 weeks for 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
Study officials:
References: