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

Breast Cancer Clinical Trial

— KUNLUN-001  

Official title:

A Phase I Study on Engineering Tumor Infiltrating Lymphocytes Injection (GC203 TIL) for the Treatment of Advanced Malignant Solid Tumors

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06375187
• Other study ID #: GC203 TIL-ST-?
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: May 1, 2024
• Est. completion date: May 1, 2027

Study information

• Verified date: April 2024
• Source: Shanghai Juncell Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A clinical trial to assess the safety and efficacy of engineered Tumor Infiltrating Lymphocytes (TIL) for the treatment of Advanced Malignant Solid Tumors

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 18
• Est. completion date: May 1, 2027
• Est. primary completion date: November 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Gastrointestinal Cancer
• Gastrointestinal Neoplasms
• Gynecologic Cancer
• Lung Cancer
• Solid Tumor

Intervention

Biological:
• Engineering 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Juncell Therapeutics

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal Tolerance Dose		Up to Day 28
Primary	Dose Limiting Toxicity		Up to Day 28
Primary	Adverse Events		Maximum 360 days
Secondary	Objective Response Rate	Evaluate the efficacy endpoints of ORR by the investigator with RECIST v1.1 and iRECIST	Every 6 weeks for 12 months
Secondary	Duration of Response	Evaluate the efficacy endpoints of DoR by the investigator with RECIST v1.1 and iRECIST	Every 6 weeks for 12 months
Secondary	Disease Control Rate	Evaluate the efficacy endpoints of DCR by the investigator with RECIST v1.1 and iRECIST	Every 6 weeks for 12 months
Secondary	Progression-Free Survival	Evaluate the efficacy endpoints of PFS by the investigator with RECIST v1.1 and iRECIST	Every 6 weeks for 12 months
Secondary	Overall Survival	Evaluate the efficacy endpoints of OS by the investigator with RECIST v1.1 and iRECIST	Every 6 weeks for 12 months
Secondary	Quality of Life Assessment	Evaluate with EORTC QLQ-C30	Every 6 weeks for 12 months