Clear Cell Renal Cell CarcinomaPhase 1NCT07770802
Clinical Study of HS-IT101 Injection in the Treatment of Advanced Renal Cancer(FASTIL-Renal01)
A Phase 1 study testing Cyclophosphamid, Fludarabine and Interleukin 2 subcutaneous injection in people with Clear Cell Renal Cell Carcinoma, run by Hangzhou Huasai Biomedicine Co., Ltd. at 2 sites in China.
Trial summary
A Single-Arm, Open-Label, Interventional Study to Evaluate the Efficacy of HS-IT101 Autologous Tumor-Infiltrating Lymphocyte (TIL) Cell Therapy After Lymphodepleting Preconditioning with Fludarabine and Cyclophosphamide and Subsequent Interleukin-2 Therapy in Patients with Advanced Renal Cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Clear Cell Renal Cell Carcinoma
- What is being tested?
- Cyclophosphamid, Fludarabine and Interleukin 2 subcutaneous injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesChina
- Study dates
- 23 Aug 2026to Aug 2028
- Phase
- 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
- Aged 18 to 75 years old, regardless of gender;
- Pathologically confirmed by histology and/or cytology as metastatic or unresectable clear cell renal cell carcinoma (defined as clear cell component accounting for more than 50%), and has experienced treatment failure after at least one previous first-line standard therapy;
- Before screening, there is at least one biopsiable lesion that has not received radiation therapy or other local treatments (such as ablation therapy, oncolytic virus, etc.) within 28 days, and the lesion meets the sampling requirements;
- After tumor tissue sampling, there is at least one measurable tumor lesion defined by the RECIST 1.1 criteria (Lesions located in areas that have received previous local treatment, including previous radiotherapy, are not considered measurable lesions, unless it is confirmed that the lesion in this area has developed disease progression as defined by RECIST 1.1 after local treatment); (5) ECOG performance status is 0 or 1;
- Expected survival time ≥ 3 months; (7) Evaluated via laboratory and other examinations during the screening period, the participant has good organ function; (8) Before tumor tissue collection, adverse reactions caused by previous treatment have recovered to ≤ Grade 1 in accordance with the Common Terminology Criteria for Adverse Events (CTCAE) 6.0, except for toxicities that investigators judge have no safety risk, such as hyperthyroidism and hair loss; (9) Agree to take effective non-drug contraceptive measures from the date of signing the informed consent form to the end of the study; (10) Fully understand this trial, voluntarily sign the informed consent form, and are able to comply with the visit and relevant procedures specified in the study protocol.
Who cannot join
- Use of any immunosuppressive medications, such as corticosteroids, within 4 weeks prior to tumor tissue collection, or presence of a concurrent disease requiring immunosuppressive medication during the study as judged by the investigator. Intranasal or topical corticosteroid use is allowed.
- Major organ surgery or significant trauma within 4 weeks prior to screening, or requirement for elective surgery during the study, except cytoreductive surgery performed for tumor tissue collection.
- Received systemic anticancer therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to tumor tissue collection.
- Received a live vaccine within 3 months prior to screening, or plans to receive a live vaccine during the study.
- History of severe hypersensitivity reaction to any drug used in the study.
- Prior treatment with similar cell therapy products.
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- Prior organ transplantation or hematopoietic stem cell transplantation.
- Gastrointestinal bleeding requiring surgical treatment, intestinal ischemia, or perforation.
- Any of the following events within 6 months prior to screening: 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 ischemic attack, or cerebral embolism.
- Diagnosis of another primary malignancy within 5 years prior to screening, except curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or curatively resected carcinoma in situ.
- Pleural effusion, pericardial effusion, or ascites that remains uncontrolled despite drainage or requires repeated drainage.
- Surgical complications or delayed wound healing prior to screening that, in the investigator's judgment, would increase the risk of study treatment.
- 13Severe respiratory disease. 14.Known leptomeningeal metastasis; symptomatic central nervous system (CNS) metastases. Participants with previously treated brain metastases who are clinically stable (as confirmed by MRI) for at least 12 weeks may be enrolled.
- 15.Any uncontrolled clinical condition. 16.Active autoimmune disease requiring systemic treatment during the study. 17.Presence of acute or chronic infection. 18.Pregnant or breastfeeding women. 19.Known psychiatric illness, alcoholism, drug abuse, or substance abuse. 20.Any other condition that, in the investigator's opinion, makes the participant unsuitable for the study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing
Jun Guo Chief Physician, 010-88121122, guoj307@126.com
- Recruiting
Beijing Gobroad Hospital
Beijing
Chuan liang Cui Chief Physician, 86-010-50951957, cuicl@gobroadhealthcare.com
About this study
Official title: A Phase Ib, Open-Label Clinical Study of HS-IT101 Injection in Patients With Advanced Renal Cancer
A Single-Arm, Open-Label, Interventional Study to Evaluate the Efficacy of HS-IT101 Autologous Tumor-Infiltrating Lymphocyte (TIL) Cell Therapy After Lymphodepleting Preconditioning with Fludarabine and Cyclophosphamide and Subsequent Interleukin-2 Therapy in Patients with Advanced Renal Cancer.
- Conditions
- Clear Cell Renal Cell Carcinoma
- Being tested
- Cyclophosphamid, Fludarabine, Interleukin 2 subcutaneous injection, HS-IT101 monotherapy
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophosphamidDrug
Cyclophosphamide administered via intravenous infusion once daily for 3 consecutive days.
FludarabineDrug
Fludarabine is administered once daily via intravenous infusion for 3 consecutive days.
Interleukin 2 subcutaneous injectionDrug
IL-2 is administered subcutaneously or intravenously once daily. The dose may be adjusted based on the subject's tolerance, including modifications to the dose, dosing frequency, or complete discontinuation of treatment, Up to three administrations.
HS-IT101 monotherapyDrug
TIL Injection administered by intravenous infusion over 30-60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| HS-IT101 monotherapy | Experimental | TIL Injection administered by intravenous infusion over 30-60 minutes. Receives: Drug: Cyclophosphamid; Drug: Fludarabine; Drug: Interleukin 2 subcutaneous injection; Drug: HS-IT101 monotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability: Incidence and Severity of Adverse Events (AE) and Serious Adverse Events (SAE)
Measured: 2 years
Secondary outcomes (3)
The objective response rate (ORR), disease control rate (DCR), duration of response (DOR), time to response (TTR), and progression-free survival (PFS) assessed by researchers based on the RECIST v1.1 criteria.
Measured: 2 years
Overall Survival（OS）
Measured: 2 years
The pharmacokinetic (PK) detection indicators for HS-IT101 injection include peripheral blood lymphocyte subsets and T-cell antigen receptor (TCR) clonotypes.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start23 Aug 2026
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clear Cell Renal Cell CarcinomaStudies 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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangzhou Huasai Biomedicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07770802
- Sponsor's protocol ID
- HS-IT101-104
- Status last verified
- Aug 2026
- First submitted
- 13 Aug 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No