NCT05831033 Safety and Efficacy of an Autologous Tumor Infiltrating Lymphocyte (TIL) Therapy in Patients with Advanced Solid Tumors
| NCT ID | NCT05831033 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine |
| Condition | Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 16 participants |
| Start Date | 2023-05-23 |
| Primary Completion | 2027-02-15 |
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 16 participants in total. It began in 2023-05-23 with a primary completion date of 2027-02-15.
⚠ 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
Multicenter, single arm, non-randomized, prospective, open label, interventional study evaluating adoptive cell therapy (ACT) with autologous tumor infiltrating lymphocytes (TIL) infusion (BEN101) followed by IL-2 after a non-myeloablative (NMA) lymphodepletion preparative regimen for the treatment of patients with recurrent and/or metastatic solid tumor.
Eligibility Criteria
Inclusion criteria 1. Be able and willing to provide written informed consent, and to comply with all requirements of study participation (including all study procedures). 2. Age: 18 - 75 years. 3. Histological or cytological diagnosis of advanced metastatic solid tumors. 4. Progression on standard therapy, or intolerance to, refusal or unable to benefit from standard therapy according to investigator's judgement. 5. At least one resectable lesion (or aggregate of lesions) of a minimum 15 mm in diameter post-resection; or core biopsy (aggregate of around 1 gram or two 18G puncture needles). 6. At least one measurable target lesion, as defined by RECIST v1.1.Lesions in previously irradiated areas (or other local therapy) should not be selected as target lesions, unless treatment was ≥ 3 months prior to screening, and there has been demonstrated disease progression in that particular lesion. 7. ECOG performance status of 0 or 1. 8. Life expectancy of at least 3 months. 9. Adequate organ and marrow function (hematology, renal, hepatic and coagulation). 1. Absolute neutrophil count (ANC) ≥ 1.0×10\^9/L. 2. Hemoglobin (Hb) ≥ 80 g/L. 3. Platelet ≥ 75×10\^9/L. 4. Sufficient coagulation: APPT\<40 and INR\<1,5. 5. Creatinine clearance (CrCL) ≥45 mL/min or serum creatinine ≤1.5mg/dL was estimated using the Cockcroft-Gault formula. 6. Serum alanine transaminase (ALT)/ serum glutamic-pyruvic transaminase (SGPT) and aspartate transaminase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) ≤ 3 times the upper limit of normal (ULN); patients with liver metastasis ≤ 5 times ULN. 7. Estimated creatinine clearance (eCrCl) ≥ 40 mL/min using the Cockcroft-Gault formula. 8. Total bilirubin ≤ 1.5 times ULN. 9. Patients with Gilbert\'s syndrome must have a total bilirubin ≤ 1.5 times ULN. 10. Patients with left ventricular ejection fraction (LVEF) ≥50% or New York Heart Association (NYHA) functional classification ≤ Class 1. 11. Patients with pulmonary function test (forced expiratory volume in 1 second FEV1) ≥75%. Exclusion criteria 1. Patients who have received an organ allograft or prior cell transfer therapy. 2. Patients who have a history of hypersensitivity to any component or excipient of study drugs. 3. Patients who have active central nervous system (CNS) metastases（except stable brain metastases without hormone dependence or drug treatment within 3 months before enrollment）. 4. Patients who have active medical illness(es) that would pose increased risk for study participation, including: active systemic infections requiring systemic antibiotic therapy, coagulation disorders, or other active major medical illnesses of the cardiovascular, respiratory, or immune system. 5. Active hepatitis C subjects (Hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive), human immunodeficiency virus (HIV) antibody positive; syphilis primary screening antibody positive; untreated active hepatitis B subjects (hepatitis B surface antigen (HBsAg) positive, or hepatitis B core antibody (HBcAb) positive and peripheral blood HBV DNA quantitative test greater than ULN), hepatitis B subjects need to receive anti-HBV treatment during the study period. 6. Previous history of immunodeficiency (any form, primary or acquired), current long-term use of systemic corticosteroids or other immunosuppressants. Patients receiving steroids as replacement therapy for adrenocortical insufficiency at ≤ 10 mg/day of prednisone or other steroid equivalent may be eligible. 7. Patients who have had another primary malignancy within the previous 3 years (with the exception of carcinoma in situ of the breast, cervix, or bladder; localized prostate cancer; and non-melanoma skin cancer that has been adequately treated). 8. Patients who have received a live or attenuated vaccine within 28 days before signing the informed consent. 9. Received other cell therapy products in the past. 10. History of Grade ≥3 immune mediated AE (including AST/ALT elevations that where considered drug related and cytokine release syndrome) that was considered related to prior immune modulatory therapy (eg, immune checkpoint inhibitors, co-stimulatory agents, etc.) and required immunosuppressive therapy. 11. Patients who are pregnant or breastfeeding. 12. Before enrollment, adverse event due to any previous treatment or surgery which had not recovered to ≤ Grade 1 (according to CTCAE V5.0); except: alopecia, peripheral neuropathy ≤ grade 2, events that remain stable during supportive therapy (such as stable hypothyroidism with hormone replacement therapy), or other events that have no safety risk as assessed by the investigator. 13. Patients who do not consent to the use of medically approved contraceptive methods during the study. 14. Patients whose cancer requires immediate attention or who in the investigator's judgement is not suitable to participate in this trial.
Contact & Investigator
Hongxia Wang, Doctor
PRINCIPAL INVESTIGATOR
Shanghai General Hospital, Fudan University Shanghai Cancer Center
Frequently Asked Questions
Who can join the NCT05831033 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 NCT05831033 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 NCT05831033 currently recruiting?
Yes, NCT05831033 is actively recruiting participants. Contact the research team at jianhuachen15@163.com for enrollment information.
Where is the NCT05831033 trial being conducted?
This trial is being conducted at Shanghai, China, Shanghai, China, Shanghai, China.
Who is sponsoring the NCT05831033 clinical trial?
NCT05831033 is sponsored by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine. The principal investigator is Hongxia Wang, Doctor at Shanghai General Hospital, Fudan University Shanghai Cancer Center. The trial plans to enroll 16 participants.