Engineering Tumor Infiltrating Lymphocytes Injection (GC203 TIL) for the Treatment of Advanced Malignant Solid Tumors

Last updated: July 19, 2024
Sponsor: Shanghai Juncell Therapeutics
Overall Status: Active - Recruiting

Phase

1

Condition

Digestive System Neoplasms

Pelvic Cancer

Colon Cancer; Rectal Cancer

Treatment

Engineering Tumor Infiltrating Lymphocytes

Clinical Study ID

NCT06375187
GC203 TIL-ST-Ⅰ
  • Ages 18-75
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  1. In the opinion of the Investigator, patients must be able to sign the ICF andcomplete all study-required procedures.

  2. Patients must be ≥18 and ≤75 years of age at the time of consent. 3. Patientswith advanced metastatic solid tumors with clear pathological diagnosis havefailed standard therapy (standard therapy is defined as existing guidelines andconsensus recommended therapy [including but not limited to chemotherapeutictherapy, 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.

  3. Patients have feasible tissue areas for tumor resection/puncture to generateGC203 TIL, the total volume of the tissue > 400mm3, and the lesion has notreceived local treatment (such as radiotherapy, radiofrequency therapy,oncolytic virus, etc.) or has progressed after local treatment; 5. At least onemeasurable target lesion before preconditioning, as defined by RECIST1.1.

  4. Patients must have an Eastern Cooperative Oncology Group (ECOG) performancestatus of 0 or 1.

  5. Patients must have an estimated life expectancy of ≥3 months. 8. Patients musthave the following hematologic parameters, Coagulation functions and hepaticand 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 CreatinineClearance≥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), musthave a negative serum pregnancy test prior to treatment. All sexually activeWCBP and all sexually active male subjects must agree to use effective methodsof birth control throughout the study.

  1. Patients must have no contraindications for surgery or biopsy. 11.Patients have good compliance and be able to adhere to research accessplans and other protocol requirements.

Exclusion

Exclusion Criteria:

  1. Participate in clinical trials of other drugs or biologic therapies within 4 weeksbefore enrollment;

  2. Participants who have had a history of allogeneic T cell therapy; gene engineeringautologous 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 tothe start of treatment

  6. Patients with a history of hypersensitivity to any component of the study drugs

  7. Patients who are pregnant or breastfeeding.

Study Design

Total Participants: 18
Treatment Group(s): 1
Primary Treatment: Engineering Tumor Infiltrating Lymphocytes
Phase: 1
Study Start date:
May 29, 2024
Estimated Completion Date:
May 01, 2027

Connect with a study center

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032
    China

    Active - Recruiting

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