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Breast CancerEarly Phase 1NCT05505812

Study on the Safety and Efficacy of Autogenous Tumor Infiltrates Lymphocytes for the Treatment of Advanced Breast Cancer

A Early Phase 1 study testing HS-IT101 in people with Breast Cancer, run by The Affiliated Hospital of Qingdao University at 1 site in China.

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
Search all trials

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, women only
Conditions the study is for
Breast Cancer
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
10 participants
Where
1 siteChina
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
  • Women only
  • 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 (Female);
  • Histologically or cytological diagnosed as advanced breast cancer;
  • 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;
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  • 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 no○rmalized 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);
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  • 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;
  • 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

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Haibo Wang, MD contact

18661805787

hbwang66@126.com

China1 site

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong

    Xin Li, Ph.D, +86 053282912263, jidi1767@126.com

Other trials in China

About this study

Official title: Study on the Safety and Efficacy of Autogenous Tumor Infiltrates Lymphocytes (HS-IT101) for the Treatment of Advanced Breast Cancer

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 breast cancer.

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 breast cancer. 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
Breast Cancer
Being tested
HS-IT101
Medical subject headings
Breast Neoplasms

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 NCT05505812
Study groupRoleWhat they receive
HS-IT101 monotherapyExperimental1x10^9-6x10^10 in vitro expanded autologous TIL (HS-IT101) will be infused i.v. to patients with advanced breast cancer 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.

  1. Adverse Events (AE)

    To characterize the safety profile of HS-IT101 in patients with advanced breast cancer as assessed by incidence of adverse events.

    Measured: 12 months

Secondary outcomes (4)

  1. Objective Response Rate (ORR)

    To evaluate the efficacy of HS-IT101 in patients with advanced breast cancer, based on the objective response rate (ORR) as assessed by the Independent Review Committee (IRC) per RECIST v1.1

    Measured: Up to 36 months

  2. Time-to-response (TTR)

    To evaluate the efficacy of HS-IT101 in patients with advanced breast cancer by assessing the time-to-response (TTR) as assessed by the Investigator per RECIST v1.1

    Measured: Up to 36 months

  3. Duration of Response (DOR)

    To evaluate the efficacy of HS-IT101 in patients with advanced breast cancer by assessing the duration of response (DOR) as assessed by the Investigator per RECIST v1.1

    Measured: Up to 36 months

  4. Overall Survival (OS)

    To evaluate overall survival (OS) in patients with advanced breast cancer

    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.

  1. First posted18 Aug 2022
  2. Study start8 Oct 2022 (estimated)
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion31 Mar 2027 (estimated)

Resources

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
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05505812
Sponsor's protocol ID
wanghaibo
Status last verified
Aug 2022
First submitted
16 Aug 2022
Last updated
18 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing HS-IT101 in people with Breast Cancer, run by The Affiliated Hospital of Qingdao University at 1 site 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 17 inclusion and 24 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 18 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 Haibo Wang, MD (18661805787, hbwang66@126.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?

On the ClinicalTrials.gov record for NCT05505812.

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 18 Aug 2022.

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