Advanced Solid TumorEarly Phase 1NCT05539768
Study on the Safety and Efficacy of Autogenous Tumor Infiltrates Lymphocytes for the Treatment of Advanced Solid Tumor
A Early Phase 1 study testing HS-IT101 in people with Advanced Solid Tumor, run by The Affiliated Hospital of Qingdao University.
Trial summary
Prospective, single-center, single-arm, open-label,interventional study evaluating adoptive cell therapy (ACT) with autologous tumor-infiltrating lymphocyte (TIL) infusion (HS-IT101) after lymphodepletion preparative with fludarabine and cyclophosphamide regimen, followed by IL-2, 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
- Advanced Solid Tumor
- What is being tested?
- HS-IT101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- 8 Oct 2022to 31 Mar 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
- To be eligible for the study, patients must meet ALL of the following criteria prior to participation:
- Age: 18 years to 75 years at the time of consent;
- Histologically or cytological diagnosed as advanced soild tumor:
- Advanced non-small cell lung cancer (NSCLC), both male and female. Neuroendocrine cancers, or mixed neuroendocrine features in >10% of tumor cells, are excluded;
- Advanced cervical cancer;
- Advanced breast cancer (only female)
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- Test subjects have failed first-line standard treatment regimens, and there are no available effective treatment regimens option or refuses to accept further treatment;
- At least one resectable lesion that has not received radiotherapy or other local therapy within 28 days, and of aminimum 1cm∧3 resection；or resectable lesions capable of producing sufficient TIL；
- At least one measurable target lesion, as defined by RECIST v1.1，that has not received radiotherapy or other local therapy unless these therapies occurred 28 days ago and target lesion shows significant progression;
- ECOG score 0-2;
- Expected life-span more than 3 months;
- Adequate organ and bone marrow function:
- Absolute count of neutrophil ≥1.5×10^9/L; Platelet count ≥90×10^9/L; Hemoglobin ≥ 90g/L (None blood transfusion or erythropoietin treatment within 14 days); AST, ALT≤2.5×ULN (subjects with liver metastasis ≤5×ULN); Totol bilirubin ≤1.5×ULN; Serum creatinine ≤1.5×ULN, or estimated creatinine clearance (CrCl)≥45 mL/min (Cockcroft-Gault formula); Activated partial thromboplastin time (APTT) ≤1.5×ULN, while international normalized ratio (INR) or prothrombin (PT) ≤1.5×ULN; LVEF ≥ 50%, none symptomatic or poorly controlled arrhythmias;
- Test subjects must have recovered from all prior therapy-related toxicities to ≤Grade 1 according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0; except for alopecia (tumor resection);
- Test subjects with child-bearing potential must be willing to practice approved highly effective methods of contraception at the time of informed consent, and continue within 180 days after the completion of treatment；
- Be able to understand and sign the informed consent document.
Who cannot join
- Patients with any of the following criteria will not be allowed to participation:
- Test subjects who have a history of hypersensitivity to any component or excipient of HS-IT101 or other study drugs (cyclophosphamide, fludarabine and recombinant human interleukin-2);
- Test subjects have any uncontrollable clinical problems (including but not limited):
- hypertension poorly controlled by medication (blood pressure ≥150/90mmHg at rest after taking medication); poorly controlled diabetes; cardiac disease (New York Heart Association class Ⅲ/Ⅳ congestive heart failure or heart block);
- Test subjects who have active major medical illnesse(es) of the cardiovascular (within 6 months prior to enrollment), including deep vein thrombosis or pulmonary embolism; myocardial infarction; severe or unstable arrhythmia or angina pectoris; percutaneous coronary intervention, acute coronary syndrome, coronary artery bypass grafting; cerebrovascular accident, transient cerebral ischemia Seizures, cerebral embolism;
- Active autoimmune diseases or recipients of organ transplants that require systemic treatment during the study period, or a history of such diseases within the past 2 years;
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- Prior used any immunosuppressive medications, such as corticosteroids (within 14 days prior to enrollment); physiological doses of glucocorticoids (≤10 mg/day prednisone or equivalent) are permitted, as well as inhaled, intranasal, or topical corticosteroids;
- Test subjects with symptomatic and/or untreated brain metastases;
- Current or prior use of anticancer therapy: a. chemotherapy, immune checkpoint inhibitor, other investigational therapy drug or local treatment for target lesions within the past 4 weeks; b. chinese patent medicine with anti-tumor indications, or systemic therapy with immunomodulatory drugs (including thymosin, interferon, drugs targeting) within the past 2 weeks; c. targeted drug therapy within the past 4 weeks or 5 half-lives, whichever is shorter;
- Presence of acute or chronic infection:
- Human immunodeficiency virus (HIV) infection or anti-HIV antibody positive; Active TB infection; Active bacterial or fungal infection requiring systemic treatment; HBsAg and/or HBeAg positive; Hepatitis C patients; Treponema pallidum antibodies positive;
- Vaccinated with the new coronavirus vaccine within 14 days propr to screening, or who have received a live vaccine within 3 months, or who plan to receive live vaccine during the trial;
- Major organs underwent surgery (excluding needle biopsy) or significant trauma within 4 weeks before screening；required elective surgery during the study;
- Test subjects who have had another primary malignancy within the previous 5 years, excluding basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or carcinoma in situ after radical resection;
- Females in pregnancy or lactation;
- Test subjects have had SAE requiring blood product support occurred in previous chemotherapy, including but not limited to whole blood, red blood cells, platelets;
- Subject have mental illness, alcoholism, drug or substance abuse；or researchers considering the test subject as having other reasons inappropriate for the clinical study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Study on the Safety and Efficacy of Autogenous Tumor Infiltrates Lymphocytes (HS-IT101) for the Treatment of Advanced Solid Tumor
Prospective, single-center, single-arm, open-label,interventional study evaluating adoptive cell therapy (ACT) with autologous tumor-infiltrating lymphocyte (TIL) infusion (HS-IT101) after lymphodepletion preparative with fludarabine and cyclophosphamide regimen, followed by IL-2, for the treatment of patients with advanced solid tumor.
Read the detailed description
HS-IT101 is an adoptive cell transfer therapy that utilizes an autologous TIL manufacturing process, for the treatment of patients with advanced solid tumor. The cell transfer therapy used in this study involves patients receiving lymphodepletion treatment with fludarabine and cyclophosphamide, followed by infusion of autologous TIL, then finnaly followed by the administration of a regimen of IL-2.
- Conditions
- Advanced Solid Tumor
- Being tested
- HS-IT101
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-IT101Biological
Adoptive transfer of 1x10^9-6x10^10 autologous TIL to patients i.v. in 30-60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| HS-IT101 monotherapy | Experimental | 1x10^9-6x10^10 in vitro expanded autologous TIL (HS-IT101) will be infused i.v. to patients with advanced solid tumor after lymphodepletion treatment with fludarabine and cyclophosphamide, and then followed by the administration of a regimen of IL-2. Receives: Biological: HS-IT101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AE)
To characterize the safety profile of HS-IT101 in patients with advanced solid tumor as assessed by incidence of adverse events
Measured: 12 months
Secondary outcomes (4)
Objective Response Rate (ORR)
To evaluate the efficacy of HS-IT101 in patients with advanced solid tumor, based on the objective response rate (ORR) as assessed by the Independent Review Committee (IRC) per RECIST v1.1
Measured: Up to 36 months
Time-to-response (TTR)
To evaluate the efficacy of HS-IT101 in patients with advanced solid tumor by assessing the time-to-response (TTR) as assessed by the Investigator per RECIST v1.1
Measured: Up to 36 months
Duration of Response (DOR) Duration of Response (DOR)
To evaluate the efficacy of HS-IT101 in patients with advanced solid tumor by assessing the duration of response (DOR) as assessed by the Investigator per RECIST v1.1
Measured: Up to 36 months
Overall Survival (OS)
To evaluate overall survival (OS) in patients with advanced solid tumor
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start8 Oct 2022 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- More trials run by The Affiliated Hospital of Qingdao UniversityThe 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
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Collaborators
- Hangzhou Huasai Biomedicine Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Jing Wang, MD, Principal investigator, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05539768
- Sponsor's protocol ID
- HS-IT101-ST001
- Status last verified
- Sep 2022
- First submitted
- 12 Sep 2022
- Last updated
- 14 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Safety and Efficacy of Autogenous Tumor Infiltrates Lymphocytes (HS-IT101) for the Treatment of Advanced Solid Tumor
- ClinicalTrials.gov ID
- NCT05539768
- Acronym / sponsor ID
- HS-IT101-ST001
- Conditions
- Advanced Solid Tumor
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Collaborators
- Hangzhou Huasai Biomedicine Co., Ltd.
- Study start
- 8 Oct 2022 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 14 Sep 2022 (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.
Prospective, single-center, single-arm, open-label,interventional study evaluating adoptive cell therapy (ACT) with autologous tumor-infiltrating lymphocyte (TIL) infusion (HS-IT101) after lymphodepletion preparative with fludarabine and cyclophosphamide regimen, followed by IL-2, for the treatment of patients with advanced solid tumor.
Detailed description
HS-IT101 is an adoptive cell transfer therapy that utilizes an autologous TIL manufacturing process, for the treatment of patients with advanced solid tumor. The cell transfer therapy used in this study involves patients receiving lymphodepletion treatment with fludarabine and cyclophosphamide, followed by infusion of autologous TIL, then finnaly 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 |
|---|---|---|
| HS-IT101 monotherapy | Experimental | Biological: HS-IT1011x10^9-6x10^10 in vitro expanded autologous TIL (HS-IT101) will be infused i.v. to patients with advanced solid tumor after lymphodepletion treatment with fludarabine and cyclophosphamide, and then followed by the administration of a regimen of IL-2. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- To be eligible for the study, patients must meet ALL of the following criteria prior to participation:
- Absolute count of neutrophil ≥1.5×10^9/L; Platelet count ≥90×10^9/L; Hemoglobin ≥ 90g/L (None blood transfusion or erythropoietin treatment within 14 days); AST, ALT≤2.5×ULN (subjects with liver metastasis ≤5×ULN); Totol bilirubin ≤1.5×ULN; Serum creatinine ≤1.5×ULN, or estimated creatinine clearance (CrCl)≥45 mL/min (Cockcroft-Gault formula); Activated partial thromboplastin time (APTT) ≤1.5×ULN, while international normalized ratio (INR) or prothrombin (PT) ≤1.5×ULN; LVEF ≥ 50%, none symptomatic or poorly controlled arrhythmias;
Key exclusion criteria (17 listed)
- Patients with any of the following criteria will not be allowed to participation:
- hypertension poorly controlled by medication (blood pressure ≥150/90mmHg at rest after taking medication); poorly controlled diabetes; cardiac disease (New York Heart Association class Ⅲ/Ⅳ congestive heart failure or heart block);
- Human immunodeficiency virus (HIV) infection or anti-HIV antibody positive; Active TB infection; Active bacterial or fungal infection requiring systemic treatment; HBsAg and/or HBeAg positive; Hepatitis C patients; Treponema pallidum antibodies positive;
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 |
|---|---|---|
| HS-IT101Adoptive transfer of 1x10^9-6x10^10 autologous TIL to patients i.v. in 30-60 minutes. | Biological | HS-IT101 monotherapy |
Primary outcome
Adverse Events (AE)
Time frame: 12 months
To characterize the safety profile of HS-IT101 in patients with advanced solid tumor as assessed by incidence of adverse events
4 secondary outcomes
Objective Response Rate (ORR)
Time frame: Up to 36 months
Time-to-response (TTR)
Time frame: Up to 36 months
Duration of Response (DOR) Duration of Response (DOR)
Time frame: Up to 36 months
Overall Survival (OS)
Time frame: Up to 36 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 14 Sep 2022.
- Individual participant dataSharing planned: No
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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.
Jing Wang, MD principal investigator
The Affiliated Hospital of Qingdao University
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing HS-IT101 in people with Advanced Solid Tumor, run by The Affiliated Hospital of Qingdao University.
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 16 inclusion and 17 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: opening soon, as of the sponsor's last update on 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Jing Wang, MD (18661805686, wangstella5@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: 12 months). 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 14 Sep 2022.