Solid TumorEarly Phase 1NCT05831033
Safety and Efficacy of an Autologous Tumor Infiltrating Lymphocyte (TIL) Therapy in Patients with Advanced Solid Tumors
A Early Phase 1 study testing BEN101 in people with Solid Tumor, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 3 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumor
- What is being tested?
- BEN101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 3 sitesChina
- Study dates
- 23 May 2023to 15 Jun 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be able and willing to provide written informed consent, and to comply with all requirements of study participation (including all study procedures).
- Age: 18 - 75 years.
- Histological or cytological diagnosis of advanced metastatic solid tumors.
- Progression on standard therapy, or intolerance to, refusal or unable to benefit from standard therapy according to investigator's judgement.
- 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).
- 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.
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- ECOG performance status of 0 or 1.
- Life expectancy of at least 3 months.
- Adequate organ and marrow function (hematology, renal, hepatic and coagulation).
- Absolute neutrophil count (ANC) ≥ 1.0×10^9/L.
- Hemoglobin (Hb) ≥ 80 g/L.
- Platelet ≥ 75×10^9/L.
- Sufficient coagulation: APPT\<40 and INR\<1,5.
- Creatinine clearance (CrCL) ≥45 mL/min or serum creatinine ≤1.5mg/dL was estimated using the Cockcroft-Gault formula.
- 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.
- Estimated creatinine clearance (eCrCl) ≥ 40 mL/min using the Cockcroft-Gault formula.
- Total bilirubin ≤ 1.5 times ULN.
- Patients with Gilbert\'s syndrome must have a total bilirubin ≤ 1.5 times ULN.
- Patients with left ventricular ejection fraction (LVEF) ≥50% or New York Heart Association (NYHA) functional classification ≤ Class 1.
- Patients with pulmonary function test (forced expiratory volume in 1 second FEV1) ≥75%.
Who cannot join
- Patients who have received an organ allograft or prior cell transfer therapy.
- Patients who have a history of hypersensitivity to any component or excipient of study drugs.
- Patients who have active central nervous system (CNS) metastases（except stable brain metastases without hormone dependence or drug treatment within 3 months before enrollment）.
- 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.
- 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.
- 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.
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- 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).
- Patients who have received a live or attenuated vaccine within 28 days before signing the informed consent.
- Received other cell therapy products in the past.
- 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.
- Patients who are pregnant or breastfeeding.
- 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.
- Patients who do not consent to the use of medically approved contraceptive methods during the study.
- Patients whose cancer requires immediate attention or who in the investigator's judgement is not suitable to participate in this trial.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Not yet recruiting
RenJi Hospital
Shanghai, Shanghai Municipality, 200125
Wenjing Wang, Master, +86 18964874021, wenjingwang2@126.com
Wen Kong, Doctor, +8613585982964, kongwen@renji.com
- Not yet recruiting
Shanghai General Hospital
Shanghai, Shanghai Municipality, 201620
weiyi Huang, Master, +86 13817373650, huangweiyi1976@163.com
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai
jianhua chen, Doctor, +86 17321168230, jianhuachen15@163.com
About this study
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.
Read the detailed description
BEN101 is an adoptive cell transfer therapy that utilizes an autologous TIL manufacturing process, for the treatment of patients with recurrent and/or metastatic solid tumor. The cell transfer therapy used in this study involves patients receiving a NMA lymphocyte depleting preparative regimen, followed by infusion of autologous TIL followed by the administration of a regimen of IL-2.
- Conditions
- Solid Tumor
- Being tested
- BEN101
- Keywords
- Cell Therapy, Autologous Adoptive Cell Therapy, Tumor Infiltrating Lymphocytes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BEN101Biological
Lymphodepletion regimen：Cyclophosphamide 250mg/ m2/day x 3 days (day -4, -3，-2) , Fludarabine 25mg/ m2/day x 2 days (day-4, -3) , Paclitaxel 100mg/ m2/day -3. The lymphodepletion regimen could be adjusted by the treating physician according to patient's disease condition.
BEN101 infusion： Single dose level between 1x10^9 to 1x 10^11，not lower than 1×10^9 cells, final dose is affected by the starting amount of TILs cells isolated from the tumor tissue sample.
IL-2：Administer 8-16 hr after TIL infusion. 600,000 IU/kg intravenously over 15-20 mins every 12 hours. It is recommended to start with high dose; and de-escalate based on tolerability, up to 5 days. IL-2 administration will be terminated if unacceptable toxicities occur.
| Study group | Role | What they receive |
|---|---|---|
| BEN101 | Experimental | BEN101 infusion single dose level between 1x10^9 to 1x 10^11，not lower than 1×10^9 cells, final dose is affected by the starting amount of TILs cells isolated from the tumor tissue sample. Receives: Biological: BEN101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AE)
Adverse events according to CTCAE v5.0, Treatment Emergent Adverse event (TEAE) >=grade 3; Treatment related adverse event (TRAE).
Measured: 6 month
Secondary outcomes (5)
Objective Response Rate (ORR)
Proportion of patients with response to evaluate efficacy parameters such as Objective Response Rate (ORR) using RECIST v1.1 as assessed by the Investigator
Measured: Up to 24 months
Disease Control Rate (DCR）
Proportion of patients with response per response to evaluate efficacy parameters such as Disease Control Rate (DCR) using RECIST v1.1 as assessed by the Investigator
Measured: Up to 24 months
Duration of response (DOR)
To evaluate efficacy parameters such as Duration of Response (DOR) using RECIST v1.1 as assessed by the Investigator
Measured: Up to 24 months
Progression free survival (PFS)
The time length between BEN101 infusion and confirmed subsequent disease progression according to RECIST 1.1
Measured: Up to 24 months
Overall survival (OS)
The length of time from the date of the start of BEN101 treatment that the patients are still alive
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start23 May 2023
- Primary completion15 Feb 2027 (estimated)
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- RenJi Hospital, Fudan University
- Responsible party
- Principal investigator, Hongxia Wang, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Hongxia Wang, Doctor, Principal investigator, Shanghai General Hospital, Fudan University Shanghai Cancer CenterWen Di, Doctor, Principal investigator, RenJi HospitalWei Xue, Doctor, Principal investigator, RenJi HospitalWeiyi Huang, Master, Principal investigator, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05831033
- Sponsor's protocol ID
- 101T1
- Status last verified
- Sep 2024
- First submitted
- 14 Apr 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: to publish papers
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of an Autologous Tumor Infiltrating Lymphocyte (TIL) Therapy in Patients with Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05831033
- Acronym / sponsor ID
- 101T1
- Conditions
- Solid Tumor
- Keywords
- Cell Therapy, Autologous Adoptive Cell Therapy, Tumor Infiltrating Lymphocytes
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- RenJi Hospital, Fudan University
- Study start
- 23 May 2023 (actual)
- Primary completion
- 15 Feb 2027 (estimated)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 26 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
BEN101 is an adoptive cell transfer therapy that utilizes an autologous TIL manufacturing process, for the treatment of patients with recurrent and/or metastatic solid tumor. The cell transfer therapy used in this study involves patients receiving a NMA lymphocyte depleting preparative regimen, followed by infusion of autologous TIL followed by the administration of a regimen of IL-2.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BEN101 | Experimental | Biological: BEN101BEN101 infusion single dose level between 1x10^9 to 1x 10^11，not lower than 1×10^9 cells, final dose is affected by the starting amount of TILs cells isolated from the tumor tissue sample. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Be able and willing to provide written informed consent, and to comply with all requirements of study participation (including all study procedures).
- Age: 18 - 75 years.
- Histological or cytological diagnosis of advanced metastatic solid tumors.
- Progression on standard therapy, or intolerance to, refusal or unable to benefit from standard therapy according to investigator's judgement.
- 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).
Key exclusion criteria (14 listed)
- Patients who have received an organ allograft or prior cell transfer therapy.
- Patients who have a history of hypersensitivity to any component or excipient of study drugs.
- Patients who have active central nervous system (CNS) metastases（except stable brain metastases without hormone dependence or drug treatment within 3 months before enrollment）.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BEN101Lymphodepletion regimen：Cyclophosphamide 250mg/ m2/day x 3 days (day -4, -3，-2) , Fludarabine 25mg/ m2/day x 2 days (day-4, -3) , Paclitaxel 100mg/ m2/day -3. The lymphodepletion regimen could be adjusted by the treating physician according to patient's disease condition. BEN101 infusion： Single dose level between 1x10^9 to 1x 10^11，not lower than 1×10^9 cells, final dose is affected by the starting amount of TILs cells isolated from the tumor tissue sample. IL-2：Administer 8-16 hr after TIL infusion. 600,000 IU/kg intravenously over 15-20 mins every 12 hours. It is recommended to start with high dose; and de-escalate based on tolerability, up to 5 days. IL-2 administration will be terminated if unacceptable toxicities occur. | Biological | BEN101 |
Primary outcome
Adverse Events (AE)
Time frame: 6 month
Adverse events according to CTCAE v5.0, Treatment Emergent Adverse event (TEAE) >=grade 3; Treatment related adverse event (TRAE).
5 secondary outcomes
Objective Response Rate (ORR)
Time frame: Up to 24 months
Disease Control Rate (DCR）
Time frame: Up to 24 months
Duration of response (DOR)
Time frame: Up to 24 months
Progression free survival (PFS)
Time frame: Up to 24 months
Overall survival (OS)
Time frame: Up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No. to publish papers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hongxia Wang, Doctor principal investigator
Shanghai General Hospital, Fudan University Shanghai Cancer Center
Wen Di, Doctor principal investigator
RenJi Hospital
Wei Xue, Doctor principal investigator
RenJi Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing BEN101 in people with Solid Tumor, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jianhua Chen, Doctor (+86 17321168230, jianhuachen15@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (AE) (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.