Actively Recruiting
Safety and Efficacy of an Autologous Tumor Infiltrating Lymphocyte (TIL) Therapy in Patients with Advanced Solid Tumors
Led by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Updated on 2024-09-19
16
Participants Needed
3
Research Sites
212 weeks
Total Duration
On this page
Sponsors
S
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor
R
RenJi Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Efficacy of an Autologous Tumor Infiltrating Lymphocyte (TIL) Therapy in Patients with Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to provide written informed consent and comply with all study procedures
- Age between 18 and 75 years
- Histological or cytological diagnosis of advanced metastatic solid tumors
- Disease progression on standard therapy, or intolerance, refusal, or inability to benefit from standard therapy
- At least one resectable lesion or core biopsy available
- At least one measurable target lesion per RECIST v1.1, not recently irradiated unless progression noted
- ECOG performance status of 0 or 1
- Life expectancy of at least 3 months
- Adequate organ and marrow function including neutrophil count ≥ 1.0x10^9/L, hemoglobin ≥ 80 g/L, platelet count ≥ 75x10^9/L
- Sufficient coagulation with APPT < 40 and INR < 1.5
- Creatinine clearance ≥ 45 mL/min or serum creatinine ≤ 1.5 mg/dL
- Liver enzymes ≤ 3 times upper limit of normal (≤ 5 times ULN if liver metastasis)
- Estimated creatinine clearance ≥ 40 mL/min
- Total bilirubin ≤ 1.5 times upper limit of normal
- Patients with Gilbert's syndrome must have total bilirubin ≤ 1.5 times ULN
- Left ventricular ejection fraction ≥ 50% or NYHA functional classification ≤ Class 1
- Pulmonary function test (FEV1) ≥ 75%
You will not qualify if you...
- History of organ allograft or prior cell transfer therapy
- Hypersensitivity to any study drug components
- Active central nervous system metastases except stable brain metastases without recent hormone or drug treatment
- Active infections requiring systemic antibiotics, coagulation disorders, or major active medical illnesses of the cardiovascular, respiratory, or immune system
- Active hepatitis C, untreated active hepatitis B, HIV positive, or untreated syphilis
- History of immunodeficiency or long-term use of systemic corticosteroids or immunosuppressants (except low-dose replacement therapy)
- Another primary malignancy within the past 3 years except certain treated cancers
- Receipt of live or attenuated vaccine within 28 days before consent
- Received other cell therapy products previously
- History of grade 3 or higher immune-mediated adverse events related to prior immune therapy requiring immunosuppressive treatment
- Pregnancy or breastfeeding
- Unresolved adverse events from prior treatments greater than grade 1 (except specified stable conditions)
- Refusal to use medically approved contraceptive methods during the study
- Cancer requiring immediate treatment or judged unsuitable for trial participation by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
RenJi Hospital
Shanghai, Shanghai Municipality, China, 200125
Not Yet Recruiting
2
Shanghai General Hospital
Shanghai, Shanghai Municipality, China, 201620
Not Yet Recruiting
3
Fudan University Shanghai Cancer Center
Shanghai, China
Actively Recruiting
Research Team
J
Jianhua Chen, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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