HS-IT101 Injection for Advanced NSCLC
- Conditions
- Advanced Non-Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT07105176
- Lead Sponsor
- Qingdao Sino-Cell Biomedicine Co., Ltd.
- Brief Summary
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 12
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description HS-IT101 monotherapy Cyclophosphamide Adoptive transfer of 5x10\^9-6x10\^10 autologous TIL to patients i.v. in 30-60 minutes. HS-IT101 monotherapy Fludarabine Adoptive transfer of 5x10\^9-6x10\^10 autologous TIL to patients i.v. in 30-60 minutes. HS-IT101 monotherapy IL-2 (interleukin 2) Adoptive transfer of 5x10\^9-6x10\^10 autologous TIL to patients i.v. in 30-60 minutes. HS-IT101 monotherapy Cyclophosphamide TIL Injection administered by intravenous infusion over 30-60 minutes. HS-IT101 monotherapy Fludarabine TIL Injection administered by intravenous infusion over 30-60 minutes. HS-IT101 monotherapy HS-IT101 monotherapy TIL Injection administered by intravenous infusion over 30-60 minutes. HS-IT101 monotherapy IL-2 (interleukin 2) TIL Injection administered by intravenous infusion over 30-60 minutes.
- Primary Outcome Measures
Name Time Method Adverse Events (AE) 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) 12 months To characterize the safety profile of HS-IT101 in patients with advanced solid tumor as assessed by incidence of serious adverse events
Objective Response Rate (ORR) Up to 36 months 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
Time-to-response (TTR) Up to 36 months 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
Duration of Response (DOR) Up to 36 months 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
Disease Control Rate (DCR) Up to 36 months 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
- Secondary Outcome Measures
Name Time Method Progression-Free-Survival (PFS) Up to 36 months To evaluate progression-free-survival (PFS) in patients with advanced solid tumor
Overall Survival (OS) Up to 36 months To evaluate overall survival (OS) in patients with advanced solid tumor
Pharmacokinetic (PK) detection parameters for HS-IT101 Up to 6 months T-cell receptor (TCR) clonality
Trial Locations
- Locations (1)
Guangdong Provincial People's Hospital
🇨🇳Guangzhou, Guangdong, China
Guangdong Provincial People's Hospital🇨🇳Guangzhou, Guangdong, ChinaYiLong WuContact86-020-83525173gdghospital_ec@gdph.org.cn