A Clinical Study of HS-IT101 Injection in Patients With Advanced Non-Small Cell Lung Cancer

NCT07830342 | Recruiting Phase 1 DMC

• 1 other identifier: HS-IT101-105
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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 Non-Small Cell Lung Cancer.

Conditions

Advanced NSCLC

Outcome Measures

Primary Outcomes (2)

• Evaluate the safety and tolerability of HS-IT101 injection in treating patients with advanced non-small cell lung cancer.

  2 years

• Evaluate the preliminary efficacy of HS-IT101 injection in treating patients with advanced non-small cell lung cancer.

  2 years

Secondary Outcomes (1)

• Evaluate the pharmacokinetic (PK) characteristics of HS-IT101 injection.

  2 years

Other Outcomes (1)

• Explore the pharmacodynamic (PD) characteristics of HS-IT101 injection.

  2 years

Study Arms (1)

HS-IT101 monotherapy

EXPERIMENTAL

TIL Injection administered by intravenous infusion over 30-60 minutes

Drug: Cyclophosphamid; Drug: Fludarabine; Drug: Interleukin 2 subcutaneous injection

Interventions

Cyclophosphamid DRUG

Cyclophosphamide administered via intravenous infusion once daily for 3 consecutive days.

HS-IT101 monotherapy

Fludarabine DRUG

Fludarabine is administered once daily via intravenous infusion for 3 consecutive days.

HS-IT101 monotherapy

Interleukin 2 subcutaneous injection DRUG

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 monotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 75 years;
• Patients with histologically or cytologically confirmed advanced, recurrent, or metastatic non-small cell lung cancer who have failed standard therapy or are intolerant to other standard therapies;
• At least one tumor lesion that has not received radiotherapy or other local treatment within 28 days and can be surgically resected and/or biopsied for the preparation of autologous tumor-infiltrating lymphocytes;
• After sampling, at least one measurable lesion as defined by RECIST 1.1 that has not received radiotherapy or other local treatment;
• ECOG performance status ≤ 1;
• Adequate organ and bone marrow function as assessed during the screening period;
• Left ventricular ejection fraction (LVEF) ≥ 50% on echocardiography; no arrhythmia requiring treatment; Fridericia-corrected QT interval (QTcF) ≤ 470 ms; baseline oxygen saturation \> 91% on room air;
• Prior treatment-related adverse events have recovered to ≤ Grade 1 per Common Terminology Criteria for Adverse Events (CTCAE) 6.0 before tumor sampling;
• Agree to use effective non-pharmacological contraceptive measures from the time of signing informed consent until 1 year after TIL cell infusion;
• Fully understand the trial and voluntarily sign the informed consent form, and be able to comply with the visits and related procedures specified in the protocol.

You may not qualify if:

• Patients with a history of severe hypersensitivity reactions to any drug used during the study;
• Any uncontrolled clinical problem, including but not limited to: poorly controlled hypertension; congestive heart failure;
• 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, or coronary artery bypass grafting; cerebrovascular accident, transient ischemic attack, or cerebral embolism;
• Active autoimmune disease requiring systemic treatment during the study;
• History of organ transplantation or hematopoietic stem cell transplantation;
• 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. However, physiological doses of glucocorticoids, intranasal or topical corticosteroids are allowed;
• Received systemic anticancer therapy within 4 weeks prior to preconditioning, or plan to participate in another interventional clinical trial during the study;
• Presence of acute or chronic infection, including: HIV positive, positive Treponema pallidum antibody, or clinically active hepatitis B or C; Active infection requiring systemic treatment or active tuberculosis infection;
• Major organ surgery or significant trauma within 4 weeks prior to screening, or requirement for elective surgery during the study;
• Surgical complications or delayed wound healing prior to screening that, in the investigator's judgment, would increase the risk of lymphodepleting preconditioning, adoptive TIL therapy, and IL-2 adjuvant therapy;
• 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;
• Severe respiratory disease;
• Gastrointestinal bleeding requiring surgical treatment, intestinal ischemia, or perforation;
• Known leptomeningeal metastasis; known other central nervous system metastases that are not effectively controlled after treatment or untreated;
• Previous treatment with a similar cell therapy product;

Sponsors & Collaborators

• Hangzhou Huasai Biomedicine Co., Ltd.: lead

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, China

RECRUITING

MeSH Terms

Interventions

Cyclophosphamide; fludarabine

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2026
• First Posted: September 21, 2026
• Study Start: September 21, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)