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Solid TumorEarly Phase 1NCT06613152

HS-IT201 Injection in the Treatment of Advanced Solid Tumors

A Early Phase 1 study testing HS-IT201 Injection in people with Solid Tumor, run by Hangzhou Huasai Biomedicine Co., Ltd..

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

Single-arm, open-label,interventional study evaluating adoptive cell therapy (ACT) with autologous tumor-infiltrating lymphocyte (TIL) infusion (HS-IT201) after lymphodepletion preparative with fludarabine and cyclophosphamide regimen, followed by IL-2, for the treatment of patients with advanced solid tumor. 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?
HS-IT201 Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
No sites listed yet
Study dates
Oct 2024to Oct 2028
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;
  • Diagnosis by cytology or histology, failure to standard treatment (including disease progression and/or adverse reactions are not tolerated) or are judged by the investigator to be unsuitable for the use of existing standards Treatment methods for patients with advanced solid tumors, including but not limited to kidney cancer, non-small cells Lung cancer, stomach cancer, colorectal cancer, melanoma, etc. Participants are required to have a minimum of menstruation Through first-line treatment.
  • At least one resectable lesion that has not received radiotherapy or other local therapy within 28 days, and the weight of the tissue must be ≥ 0.050g；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 0-1;
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  • 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; AST, ALT≤2.5×ULN (subjects with liver metastasis ≤5×ULN); Totol bilirubin ≤1.5×ULN（Gilbert syndrome≤3×ULN）; Serum creatinine ≤1.5×ULN, or estimated creatinine clearance (CrCl)≥60 mL/min (Cockcroft-Gault formula); Activated partial thromboplastin time (APTT) ≤1.5×ULN, while international normalized ratio (INR) or prothrombin (PT) ≤1.5×ULN;
  • Left ventricular ejection fraction (LVEF) ≥ 50% detected by echocardiography; Arrhythmias that do not require treatment, the QT interval (QTcF) corrected by the Fridericia method is ≤ 470 ms (QTcF is calculated using the Fridericia formula, i.e. QTcF=QT/(RR ^ 0.33), RR is the standardized heart rate value, RR=60/heart rate); If there is an abnormality during the first inspection, it can be retested twice with an interval of at least 5 minutes, and the overall result/average value should be taken to determine the qualification; Basic blood oxygen saturation in indoor natural air environment\>91%;
  • 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 1 year 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 ≥160/100mmHg 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 that require systemic treatment during the study period (eczema, vitiligo, psoriasis, alopecia or Grave\'s disease that do not require systematic treatment in the past two years, other autoimmune diseases that are not expected to recur, hypothyroidism that only requires thyroid hormone replacement therapy, and type I diabetes subjects that only require insulin replacement therapy can be included);
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  • Organ transplantation and a history of hematopoietic stem cell transplantation;
  • Any immunosuppressive drugs, such as steroids, have been used within 4 weeks prior to tumor tissue sampling, or the researcher has determined the presence of comorbidities that require the use of immunosuppressive drugs during the trial period. However, physiological doses of glucocorticoids (i.e. ≤ 12 mg/m2/day of hydrocortisone or other hormones within the equivalent dose range after equivalent dose conversion) are allowed, and steroid drugs are allowed for intranasal or local use;
  • Individuals who have received systematic anti-tumor therapy within 4 weeks prior to pre-treatment (including those who have participated in other clinical trial drug treatments; those who have metabolized 5 drugs with a half-life of less than 4 weeks, whichever is shorter) or those who plan to participate in other intervention clinical trials during the study period;
  • Presence of acute or chronic infection:
  • HIV positive, Treponema pallidum antibody positive, or clinically active hepatitis B and C, including virus carriers (excluding HBsAg and/or HBeAg positive individuals for hepatitis B; excluding HCVAb positive individuals for hepatitis C);Active infections or active tuberculosis infections that require systemic treatment;
  • Vaccinated with the new coronavirus vaccine within 4 weeks 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;
  • Patients who have surgical complications or delayed healing prior to screening, and have been determined by the researchers to increase the risk of gonorrhea pretreatment, adoptive TIL therapy, and IL-2 adjuvant therapy;
  • 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;
  • Suffering from severe respiratory system diseases (with a history of or combined with severe interstitial lung disease, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, and symptomatic bronchospasm);
  • Patients with gastrointestinal bleeding requiring surgical treatment, local intestinal ischemia or perforation;
  • Patients with known meninges metastasis; Patients with known uncontrolled or untreated central nervous system metastases (excluding those who have received stable treatment symptoms and stopped glucocorticoid and anticonvulsant drug treatment ≥ 4 weeks prior to pre-treatment);
  • Previously received similar cell therapy products;
  • Females in pregnancy or lactation;
  • 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.

Hai Tao Niu contact

18661803117

niuht0532@126.com

Wen Sheng Qiu contact

17853299919

wsqiuqd@163.com

About this study

Official title: Clinical Study on the Safety and Efficacy of HS-IT201 Injection in the Treatment of Advanced Solid Tumors

Single-arm, open-label,interventional study evaluating adoptive cell therapy (ACT) with autologous tumor-infiltrating lymphocyte (TIL) infusion (HS-IT201) 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-IT201 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
Solid Tumor
Being tested
HS-IT201 Injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HS-IT201 InjectionDrug

    Also called HS-IT201

    Adoptive transfer of 5x10^9-4x10^10 autologous TIL to patients i.v. in 30-60 minutes.

Study groups in NCT06613152
Study groupRoleWhat they receive
HS-IT201 monotherapyExperimentalAdoptive transfer of 5x10^9-4x10^10 autologous TIL to patients i.v. in 30-60 minutes.
Receives: Drug: HS-IT201 Injection

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-IT201 in patients with advanced solid tumor as assessed by incidence of adverse events

    Measured: 12 months

  2. Serious Adverse Events (SAE)

    To characterize the safety profile of HS-IT201 in patients with advanced solid tumor as assessed by incidence of serious adverse events

    Measured: 12 months

Secondary outcomes (8)

  1. Objective Response Rate (ORR)

    Committee (IRC) per RECIST v1.1

    Measured: Up to 36 months

  2. Time-to-response (TTR)

    To evaluate the efficacy of HS-IT201 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

  3. Duration of Response (DOR)

    To evaluate the efficacy of HS-IT201 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

  4. Disease Control Rate (DCR)

    To evaluate the efficacy of HS-IT201 in patients with advanced solid tumor, based on the disease control rate (DCR) as assessed by the Independent Review Committee (IRC) per RECIST v1.1

    Measured: Up to 36 months

  5. Progression-Free-Survival (PFS)

    To evaluate progression-free-survival (PFS) in patients with advanced solid tumor

    Measured: Up to 36 months

  6. Overall Survival (OS)

    To evaluate overall survival (OS) in patients with advanced solid tumor

    Measured: Up to 36 months

  7. Lymphocyte subpopulation

    Percentage and absolute count of T, B,NK cells

    Measured: Up to 6 months

  8. TCR repertoire

    VDJ recombination of the different TCR genes

    Measured: Up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2024
  2. Study startOct 2024 (estimated)
  3. Primary completionOct 2026 (estimated)
  4. Study completionOct 2028 (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
9 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06613152
Sponsor's protocol ID
HS-IT201ST01
Status last verified
Sep 2024
First submitted
22 Sep 2024
Last updated
25 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing HS-IT201 Injection in people with Solid Tumor, run by Hangzhou Huasai Biomedicine Co., Ltd..

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 13 inclusion and 21 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 25 Sep 2024. 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 Hai Tao Niu (18661803117, niuht0532@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). The study lists 2 primary outcomes in all. 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 NCT06613152.

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 25 Sep 2024.

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