NCT06375187 A Study of GC203 TIL in Advanced Malignant Solid Tumors
| NCT ID | NCT06375187 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Shanghai Juncell Therapeutics |
| Condition | Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 18 participants |
| Start Date | 2024-05-29 |
| Primary Completion | 2026-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 18 participants in total. It began in 2024-05-29 with a primary completion date of 2026-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06375187 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06375187 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06375187 currently recruiting?
Yes, NCT06375187 is actively recruiting participants. Contact the research team at clinicaltrials@juncell.com for enrollment information.
Where is the NCT06375187 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06375187 clinical trial?
NCT06375187 is sponsored by Shanghai Juncell Therapeutics. The trial plans to enroll 18 participants.