A Patient's own immune cells, grown in the lab, tested against advanced lung cancer

NCT ID NCT07830342

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 21, 2026 · Last updated Sep 21, 2026

Summary

Researchers are testing an experimental cell therapy called HS-IT101 in people with advanced non-small cell lung cancer. The treatment uses tumor-infiltrating lymphocytes (TILs), immune cells taken from the patient's own tumor, multiplied in the lab, and given back. Before receiving the cells, participants get chemotherapy drugs (fludarabine and cyclophosphamide) to make room in the immune system, followed by interleukin-2 to support the cells. The trial's main goal is to check safety and tolerability in a small group of about 12 participants.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HS-IT101, an experimental therapy made from a patient's own tumor-infiltrating lymphocytes (TILs), given after lymphodepleting chemotherapy and followed by interleukin-2
What this could lead to
If it works, this could point toward a cell therapy option for people with advanced lung cancer whose tumors have resisted standard treatment.
What could go wrong
This is a very early, very small Phase 1 trial focused first on safety, so most experimental cell therapies at this stage do not succeed. The lymphodepleting chemotherapy and interleukin-2 can cause serious side effects, and results in a dozen people may not predict how the therapy performs more broadly.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 12 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age 18 to 75 years, regardless of sex; 2. Histologically and/or cytologically confirmed metastatic or unresectable clear cell renal cell carcinoma (defined as more than 50% clear cell component); previously failed at least one line of standard therapy; 3. At least one tumor lesion suitable for collection that has not received radiotherapy or other local treatment within 28 days prior to screening, and meets the collection requirements; 4. At least one measurable tumor lesion as defined by RECIST 1.1 after tumor tissue sampling; 5. ECOG performance status of 0 or 1; 6. Life expectancy of at least 3 months; 7. Adequate organ function as assessed by laboratory tests and other examinations during the screening period; 8. Prior treatment-related adverse events have recovered to ≤ Grade 1 per Common Terminology Criteria for Adverse Events (CTCAE) 6.0 before tumor tissue collection, with the exception of toxicities judged by the investigator to pose no safety risk (such as hyperthyroidism, alopecia); 9. Agree to use effective non-pharmacologic contraceptive measures from the time of signing the informed consent form until the end of the study; 10. Fully understand the trial, voluntarily sign the informed consent form, and be able to comply with the visits and related procedures specified in the protocol. Exclusion Criteria: 1. Use of any immunosuppressive medications, such as corticosteroids, within 4 weeks prior to tumor tissue collection, or presence of a concurrent disease that, in the investigator's judgment, requires immunosuppressive medication during the study; intranasal or topical corticosteroid use is permitted. 2. Major organ surgery or significant trauma within 4 weeks prior to screening, or requirement for elective surgery during the study (except debulking surgery performed for tumor tissue collection). 3. Systemic anticancer therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to tumor tissue collection. 4. Receipt of a live vaccine within 3 months prior to screening or planned administration of a live vaccine during the study. 5. History of severe hypersensitivity reactions to any drug used during the study. 6. Prior treatment with a similar cell therapy product. 7. Prior organ transplantation or hematopoietic stem cell transplantation. 8. Gastrointestinal bleeding requiring surgical treatment, intestinal ischemia, or perforation. 9. Any of the following 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, or coronary artery bypass grafting; cerebrovascular accident, transient ischemic attack, or cerebral embolism. 10. Diagnosis of another primary malignancy within 5 years prior to screening, excluding curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or curatively resected carcinoma in situ. 11. Pleural effusion, pericardial effusion, or ascites that remains uncontrolled despite drainage or requires repeated drainage. 12. Surgical complications or delayed wound healing prior to screening that, in the investigator's judgment, would increase the risk of study treatment. 13. Severe respiratory disease. 14. Known leptomeningeal metastasis; symptomatic central nervous system metastases, unless previously treated and clinically stable (MRI) for at least 12 weeks. 15. Any uncontrolled clinical problem. 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 disorder, alcohol abuse, drug abuse, or substance abuse. 20. Any other condition that, in the investigator's opinion, makes the participant unsuitable for enrollment in this study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

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  1. The official record

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