Injecting engineered immune cells to treat advanced solid tumors
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
This study is testing a new treatment that uses specially modified immune cells taken from patients' tumors to see if it can help people with advanced cancers that haven't responded to other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Shanghai Juncell Therapeutics Industry-sponsored |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06375187 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and effectiveness of engineered Tumor Infiltrating Lymphocytes (TIL) in patients with advanced malignant solid tumors who have not responded to standard therapies. The approach involves extracting and modifying immune cells from the patient's tumor to enhance their ability to attack cancer cells. Participants will undergo procedures to obtain tumor tissue, which will then be processed to create the GC203 TIL for injection back into the patient. The study aims to provide a new treatment option for patients with various types of advanced cancers.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with advanced metastatic solid tumors that have failed standard therapies.
Not a fit: Patients with early-stage tumors or those who have not yet undergone standard treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a novel and effective option for patients with advanced solid tumors who have exhausted standard treatment options.
How similar studies have performed: Other studies using engineered TILs have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai
- Fudan University Shanghai Cancer Center — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Huajun Jin, PhD
- Email: clinicaltrials@juncell.com
- Phone: +8621-69110327
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.