HS-IT101 Injection for Advanced NSCLC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cyclophosphamide, Fludarabine, IL-2 (interleukin 2), HS-IT101 monotherapy.
- Who it may be relevant to
- Registry conditions: Advanced Non-Small Cell Lung Cancer. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase Ib Single-arm Clinical Study of HS-IT101 Injection for Advanced NSCLC
Overview
An Open-Label, Single-Arm Phase Ib Clinical Trial Evaluating the Safety, Tolerability, and Preliminary Efficacy of HS-IT101 Injection in Subjects with Advanced NSCLC.
Detailed description
A Single-Arm, Open-Label, Interventional Study Evaluating Adoptive Cell Therapy (ACT) with Autologous Tumor-Infiltrating Lymphocytes (HS-IT101) Following Lymphodepleting Conditioning with Fludarabine and Cyclophosphamide, Followed by IL-2 in Patients with Advanced NSCLC.
Interventions
- Drug Cyclophosphamide
Cyclophosphamide administered via intravenous infusion once daily for 3 consecutive days. - Drug Fludarabine
Fludarabine is administered once daily via intravenous infusion for 4 consecutive days. - Drug IL-2 (interleukin 2)
IL-2 administered subcutaneously once daily. Dosing may be adjusted based on subject tolerance, including modifications to dose quantity, administration frequency, or complete treatment discontinuation, with a maximum treatment duration of 3 days. - Drug HS-IT101 monotherapy
TIL Injection administered by intravenous infusion over 30-60 minutes.
Primary outcome measures
- Adverse Events (AE) [Time frame: 12 months]
- Serious Adverse Events (SAE) [Time frame: 12 months]
- 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]
Secondary outcome measures (4)
- Progression-Free-Survival (PFS) [Time frame: Up to 36 months]
- Overall Survival (OS) [Time frame: Up to 36 months]
- Pharmacokinetic (PK) detection parameters for HS-IT101 [Time frame: Up to 6 months]
- Pharmacokinetic (PK) detection parameters for HS-IT101 [Time frame: Up to 6 months]
Eligibility criteria
Inclusion criteria
- Age: 18-70 years (inclusive).
Diagnosis:
Histologically/cytologically confirmed advanced, recurrent, or metastatic non-small cell lung cancer (NSCLC) .
Tumor Sampling:
≥1 lesion untreated with radiotherapy/local therapy within 28 days for TIL preparation (tissue weight ≥0.050 g).
Target Lesion:
≥1 measurable lesion per RECIST v1.1, untreated with radiotherapy/local therapy (unless treatment occurred >28 days before sampling with documented progression).
Performance Status: ECOG score ≤1. Survival: Life expectancy ≥3 months.
Organ Function:
Hematology: ANC ≥1.5×10⁹/L, PLT ≥90×10⁹/L, HGB ≥90 g/L (no transfusion/erythropoietin within 14 days).
Liver: ALT/AST ≤2.5×ULN (≤5×ULN if liver metastases); TBil ≤1.5×ULN (≤3×ULN for Gilbert syndrome).
Kidney: Serum Cr ≤1.5×ULN or Ccr ≥60 mL/min (Cockcroft-Gault formula). Coagulation: APTT ≤1.5×ULN; INR/PT ≤1.5×ULN.
Cardiac Function:
LVEF ≥50% by echocardiography; QTcF ≤470 ms (Fridericia formula: QTcF = QT/RR⁰·³³).
Baseline SpO₂ >91% (room air). Note: If QTcF is abnormal initially, repeat twice at ≥5-minute intervals and use mean value for eligibility.
Toxicity Recovery: All treatment-related adverse events resolved to CTCAE v5.0 ≤Grade 1 (except alopecia/non-risk toxicities per investigator) before tumor sampling.
Contraception: Effective non-pharmacological contraception from informed consent until 1 year post-TIL infusion.
Compliance: Capable of understanding the trial, voluntarily signing informed consent, and adhering to protocol visits/procedures.
Exclusion criteria
- Severe Hypersensitivity: History of severe hypersensitivity to drugs used in the study (including but not limited to cyclophosphamide, fludarabine, IL-2, gentamicin, amphotericin B, or components of TIL infusion).
Uncontrolled Comorbidities:
Poorly controlled hypertension (resting SBP ≥160 mmHg or DBP ≥100 mmHg despite medication).
Congestive heart failure (NYHA Class III/IV).
Cardiovascular Events (within 6 months):
Deep vein thrombosis, pulmonary embolism, myocardial infarction, severe/unstable arrhythmia, angina, PCI, ACS, CABG, stroke, TIA, or cerebral embolism.
Active Autoimmune Disease:
Requires systemic therapy during the study period (Exceptions: Eczema, vitiligo, psoriasis, alopecia, or Graves' disease stable without systemic therapy for 2 years; hypothyroidism on hormone replacement; type 1 diabetes on insulin).
Transplantation History: Solid organ or hematopoietic stem cell transplantation.
Immunosuppressive Therapy:
Use of immunosuppressants (e.g., steroids) within 4 weeks before tumor sampling (Allowed: Physiologic glucocorticoid doses ≤12 mg/m²/day hydrocortisone equivalent; topical/nasal steroids).
Recent Anticancer Therapy:
Systemic anticancer treatment within 4 weeks before preconditioning (including investigational drugs; washout <5 half-lives if <4 weeks).
Planned participation in other interventional trials.
Active Infections:
HIV/syphilis antibody-positive; active HBV/HCV (Allowed: HBsAg/HBeAg+ if HBV DNA below LLN; HCV Ab+ if HCV RNA below LLN).
Active systemic infection or tuberculosis requiring treatment. Recent Surgery/Trauma: Major surgery or significant trauma within 4 weeks before screening; elective surgery planned during the study.
Poor Wound Healing: Surgery-related complications or delayed healing increasing risks of TIL therapy (per investigator judgment).
Other Malignancies: Additional primary malignancy within 5 years (Exceptions: Curatively treated basal/squamous cell carcinoma or carcinoma in situ).
Severe Respiratory Disease: History of severe ILD, COPD, pulmonary insufficiency, or symptomatic bronchospasm.
Gastrointestinal Complications: Surgical-required GI bleeding, bowel ischemia, or perforation.
CNS Involvement:
Leptomeningeal metastasis; uncontrolled/untreated CNS metastases (Exceptions: Asymptomatic lesions <1 cm, stable for ≥4 weeks without steroids/anticonvulsants).
Prior Cell Therapy: Previous treatment with similar cellular products. Pregnancy/Lactation: Pregnant or breastfeeding women.
Other Exclusions:
Psychiatric disorders, alcoholism, drug abuse, or other conditions deemed unsuitable by the investigator.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Guangdong Provincial People's Hospital — Guangzhou
Identifiers
NCT: NCT07105176 · HS-IT101ST01-Ⅰ b-02