Solid TumorPhase 1NCT06342336
HS-IT101 Injection in the Treatment of Advanced Solid Tumors
A Phase 1 study testing HS-IT101 Injection in people with Solid Tumor, run by Hangzhou Huasai Biomedicine Co., Ltd. at 1 site in China.
Trial summary
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 more about this study
- Who is it for?
- Ages 18 to 75 days
- Conditions the study is for
- Solid Tumor
- What is being tested?
- HS-IT101 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 18 Jan 2024to 31 Mar 2028
- Phase
- 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 days
- All sexes
- No healthy volunteers
- Child
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:
- 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
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Ning Li, MD, 86-010-87788713, lining@cicams.ac.cn
About this study
Official title: Single Arm, Phase I Clinical Study of HS-IT101 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-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
- Solid Tumor
- Being tested
- HS-IT101 Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-IT101 InjectionDrug
Also called HS-IT101
Adoptive transfer of 5x10^9-6x10^10 autologous TIL to patients i.v. in 30-60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| HS-IT101 monotherapy | Experimental | Adoptive transfer of 5x10^9-6x10^10 autologous TIL to patients i.v. in 30-60 minutes. Receives: Drug: HS-IT101 Injection |
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
Serious Adverse Events (SAE)
To characterize the safety profile of HS-IT101 in patients with advanced solid tumor as assessed by incidence of serious adverse events
Measured: 12 months
Secondary outcomes (8)
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)
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
Disease Control Rate (DCR)
To evaluate the efficacy of HS-IT101 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
Progression-Free-Survival (PFS)
To evaluate progression-free-survival (PFS) in patients with advanced solid tumor
Measured: Up to 36 months
Overall Survival (OS)
To evaluate overall survival (OS) in patients with advanced solid tumor
Measured: Up to 36 months
Lymphocyte subpopulation
Percentage and absolute count of T, B,NK cells
Measured: Up to 6 months
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.
- First posted2 Apr 2024
- Study start18 Jan 2024
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2028 (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.
- 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangzhou Huasai Biomedicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences, The First Hospital of Jilin University, West China Hospital
- Responsible party
- Sponsor
- Investigators
- Ning Li, MD, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06342336
- Sponsor's protocol ID
- HS-IT101ST01-I
- Status last verified
- Mar 2024
- First submitted
- 19 Mar 2024
- Last updated
- 2 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Arm, Phase I Clinical Study of HS-IT101 Injection in the Treatment of Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06342336
- Acronym / sponsor ID
- HS-IT101ST01-I
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Hangzhou Huasai Biomedicine Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences, The First Hospital of Jilin University, West China Hospital
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 2 Apr 2024 (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.
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 | Drug: HS-IT101 InjectionAdoptive transfer of 5x10^9-6x10^10 autologous TIL to patients i.v. in 30-60 minutes. |
Who may qualify
- Ages
- 18 to 75 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (13 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; 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;
Key exclusion criteria (21 listed)
- Patients with any of the following criteria will not be allowed to participation:
- 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);
- 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;
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-IT101 InjectionAlso: HS-IT101Adoptive transfer of 5x10^9-6x10^10 autologous TIL to patients i.v. in 30-60 minutes. | Drug | 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
Serious Adverse Events (SAE)
Time frame: 12 months
To characterize the safety profile of HS-IT101 in patients with advanced solid tumor as assessed by incidence of serious adverse events
8 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)
Time frame: Up to 36 months
Disease Control Rate (DCR)
Time frame: Up to 36 months
Progression-Free-Survival (PFS)
Time frame: Up to 36 months
Overall Survival (OS)
Time frame: Up to 36 months
Lymphocyte subpopulation
Time frame: Up to 6 months
TCR repertoire
Time frame: Up to 6 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 2 Apr 2024.
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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.
Ning Li, MD principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HS-IT101 Injection in people with Solid Tumor, run by Hangzhou Huasai Biomedicine Co., Ltd. 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 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: looking for participants now, as of the sponsor's last update on 2 Apr 2024. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Wenna Liu (86-0532-86685092, liuwenna@sino-cellbiomed.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?
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 2 Apr 2024.