Home BEN201 TIL Therapy Enters Clinical Trial, Recruiting Patients with Ovarian and Other Advanced Solid Tumors

BEN201 TIL Therapy Enters Clinical Trial, Recruiting Patients with Ovarian and Other Advanced Solid Tumors

Jun 17, 2025 23:59 CST Updated 23:59
Bennu Biotherapeutics

Developer of Cell and Gene Therapy Technologies

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BEN201 Injection is an autologous tumor-infiltrating lymphocyte (TILs) injection independently developed by BiNoJi (Shanghai) Biotechnology Co., Ltd., which focuses on the field of solid tumors and belongs to adoptive cell therapy (ACT).


Now, this anti-cancer breakthrough technology has officially entered clinical trials! Patients in China can now access it throughGlobal Cancer Doctors Network Medical Department (4006667998), understand the detailed inclusion and exclusion criteria, or preliminarily assess whether you qualify for participation.


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Introduction to Anti-Cancer Projects



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Drug NameAutologous Tumor-Infiltrating Lymphocytes BEN201 Injection;

Staging:Phase Ⅰ;

Lines of Treatment:Standard Treatment FailureDefeat;

Mutated Gene:No target point requirements.


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Which patients are suitable?



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Applicable toOvarian cancer, fallopian tube cancer, cervical cancer, endometrial cancer,Lung cancer, non-small cell lung cancer, etc.


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Inclusion Criteria (Partial)



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Subjects must meet all of the following criteria to be enrolled in this study:


1) Subjects aged 18-75 years;

2) Advanced recurrent or metastatic solid tumors diagnosed by histology or cytology;

3) Disease progression occurs after standard treatment (radiological assessment), or intolerance to the standard treatment regimen, or the subject refuses other treatment options, or the investigator judges that other treatment options are expected to be less beneficial;

4) At least one resectable lesion with a short axis value of 15 mm (or at least able to isolate a tissue block weighing ≥1.0g); or through core needle biopsy (requiring at least 1.0g, or approximately 2 samples from an 18G needle to extract tumor-infiltrating lymphocytes (TILs).


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Exclusion Criteria (Partial)



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Subjects must also exclude all the following criteria that make them unsuitable for participating in this clinical study before they can be enrolled:


1) Those who have undergone organ transplantation or prior cell transplantation;

2) Subjects with a known history of hypersensitivity to any component of the study drug:


①Lymphocyte-depleting preconditioning drugs and IL-2;


② Aminoglycoside antibiotics (i.e., gentamicin), excluding patients with negative gentamicin hypersensitivity skin tests;


③Any component of the BEN201 Injection infusion product formulation, including dimethyl sulfoxide (DMSO) and human serum albumin (HSA).


3) Active central nervous system (CNS) metastases (excluding stable brain metastases that have not required medication for 3 months and are non-hormone dependent).



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Clinical Benefit to Patients



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1)Free Medication: The study drug will be provided free of charge until disease progression.


2)Free Examination: Related examinations required for the trial are free of charge after being informed.


3)Transportation Allowance: Traffic subsidies related to clinical research.


4)Regular Follow-up by Experts: Full-service expert team, the institution pays long-term attention to the patient's physical condition.


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Project Implementation Region



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The research is currently being conducted in areas such as Shanghai, and specific details will be confirmed through later consultation.


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Summary of Required Documents to Submit



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The materials that patients need to prepare and submit include:Pathology Report, Genetic Testing Report, Admission Record, Discharge Summary, CT/MRI Examination, Complete Blood Count, Liver and Kidney Function, Coagulation Function, Infectious Disease Screening, Electrocardiogram Reportetc.


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Global Oncology Department Kindly Reminder
If you would like to participate in this clinical study or want to learn more about BEN201 Injection, please contactGlobal Cancer Doctors Network Medical Department (400-666-7998), obtain more information on domestic and international applications, or apply directly. We commit to keeping all participants' personal information confidential and guarantee adherence to China's laws and regulations related to clinical research throughout the entire process.



This article is original from Global Oncologist Network, reproduction is strictly prohibited without authorization.




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