HS-IT101 Injection for Advanced NSCLC

NCT07105176 | Not Yet Recruiting Phase 1

• 1 other identifier: HS-IT101ST01-Ⅰ b-02
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (6)

• Adverse Events (AE)

  To characterize the safety profile of HS-IT101 in patients with advanced solid tumor as assessed by incidence of adverse events

  12 months

• Serious Adverse Events (SAE)

  To characterize the safety profile of HS-IT101 in patients with advanced solid tumor as assessed by incidence of serious adverse events

  12 months

• Objective Response Rate (ORR)

  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

  Up to 36 months

• Time-to-response (TTR)

  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

  Up to 36 months

• Duration of Response (DOR)

  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

  Up to 36 months

• Disease Control Rate (DCR)

  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

  Up to 36 months

Secondary Outcomes (4)

• Progression-Free-Survival (PFS)

  Up to 36 months

• Overall Survival (OS)

  Up to 36 months

• Pharmacokinetic (PK) detection parameters for HS-IT101

  Up to 6 months

• Pharmacokinetic (PK) detection parameters for HS-IT101

  Up to 6 months

Study Arms (1)

HS-IT101 monotherapy

EXPERIMENTAL

TIL Injection administered by intravenous infusion over 30-60 minutes.

Drug: Cyclophosphamide; Drug: Fludarabine; Drug: IL-2 (interleukin 2); Drug: HS-IT101 monotherapy

Interventions

Cyclophosphamide 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 4 consecutive days.

HS-IT101 monotherapy

IL-2 (interleukin 2) DRUG

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.

HS-IT101 monotherapy

HS-IT101 monotherapy DRUG

TIL Injection administered by intravenous infusion over 30-60 minutes.

HS-IT101 monotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• Qingdao Sino-Cell Biomedicine Co., Ltd.: lead

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Location

MeSH Terms

Interventions

Cyclophosphamide; fludarabine; Interleukin-2

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors

Central Study Contacts

WenNa.Liu

CONTACT

（86）400-6786-208; med@sino-cellbiomed.com

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: July 22, 2025
• First Posted: August 5, 2025
• Study Start: August 30, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2027
• Last Updated: August 19, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)