Using tumor infiltrating lymphocytes to treat advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy in patients with advanced solid tumors. The approach involves expanding autologous TILs and gene-edited TILs from tumor resections or biopsies, which are then infused into the patient after a non-myeloablative lymphodepletion treatment. The treatment regimen includes hydroxychloroquine and cyclophosphamide to prepare the patient's immune system for the TIL infusion.

Why it matters

Who can join: the full rules

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

Where it's running

• Third Affiliated Hospital of Naval Medical University
  Shanghai, China Recruiting

Study contacts

• Principal investigator: Qian Zhang — Eastern Hepatobiliary Surgery Hospital
• Study coordinator: GC Clinical
• Email: clinicaltrials@juncell.com
• Phone: 086-18001759113

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Treatment of advanced gynecologic tumors using modified TIL therapy

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  Recruiting Early Phase 1 Shanghai Juncell Therapeutics · Shanghai, Shanghai Municipality · NCT05098171

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.