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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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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

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.

Jing Wang, MD contact

18661805686

wangstella5@163.com

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

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 groups in NCT05539768
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.

8 Oct 202231 Mar 2027

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.
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)

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

Interested in taking part?

Jing Wang, MD

18661805686

wangstella5@163.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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