NCT06488950 A Study of TIL in Advanced Solid Tumors (DFGD)
| NCT ID | NCT06488950 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Shanghai Juncell Therapeutics |
| Condition | Advanced Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-04-01 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 30 participants in total. It began in 2023-04-01 with a primary completion date of 2026-06-30.
⚠ 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
This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy in patients with advanced solid tumors. Autologous TILs and gene-edited TILs are expanded from tumor resections or biopsies and infused i.v. into the patient after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.
Eligibility Criteria
Inclusion Criteria: * have one the tumor resection for TILs production and successfully produced； * Age: 18 years to 75years; * Histologically diagnosed as solid tumors; * Expected life-span more than 3 months; * ECOG score 0-1; * Test subjects have failed standard treatment regimens, and be willing to receive TIL therapy; * At least 1 evaluable tumor lesion; Exclusion Criteria: * with other malignant tumors, except for the malignancies that have been cured, have been inactive for ≥5 years prior to study inclusion and have a very low risk of recurrence; Non-melanoma skin cancer or malignant lentigo with adequate treatment and no evidence of disease recurrence; Carcinoma in situ with adequate treatment and no evidence of disease recurrence; * Need glucocorticoid treatment, and daily dose of Prednisone greater than 10mg(or equivalent doses of hormones) or outoimmune diseases requiring immunomodulatory treatment; * Breathe indoor air in a quiet state, and the oxygen saturation of finger pulse is \< 95%; * Human immunodeficiency virus (HIV) infection or anti-HIV antibody positive, active HBV or HCV infection (HBsAg positive and/or anti-HCV positive), syphilis infection or Treponema pallidum antibody positive; * Significant cardiovascular anomalies
Contact & Investigator
Qian Zhang
PRINCIPAL INVESTIGATOR
Eastern Hepatobiliary Surgery Hospital
Frequently Asked Questions
Who can join the NCT06488950 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Advanced 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 NCT06488950 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 NCT06488950 currently recruiting?
Yes, NCT06488950 is actively recruiting participants. Contact the research team at clinicaltrials@juncell.com for enrollment information.
Where is the NCT06488950 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06488950 clinical trial?
NCT06488950 is sponsored by Shanghai Juncell Therapeutics. The principal investigator is Qian Zhang at Eastern Hepatobiliary Surgery Hospital. The trial plans to enroll 30 participants.