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HS-IT101 Injection for Advanced NSCLC

ConditionAdvanced Non-Small Cell Lung Cancer
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorQingdao Sino-Cell Biomedicine Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: 18-70 years (inclusive).

Disqualifiers

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).

Trial design

Design model

Single group

Treatments tested in this trial

  • Cyclophosphamide

    Drug

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

  • Fludarabine

    Drug

    Fludarabine is administered once daily via intravenous infusion for 4 consecutive days.

  • 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

    Drug

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

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: HS-IT101 monotherapyExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Adverse Events (AE)

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

Time frame
12 months
2

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

Time frame
12 months
3

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

Time frame
Up to 36 months
4

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

Time frame
Up to 36 months

Secondary outcomes

1

Progression-Free-Survival (PFS)

To evaluate progression-free-survival (PFS) in patients with advanced solid tumor

Time frame
Up to 36 months
2

Overall Survival (OS)

To evaluate overall survival (OS) in patients with advanced solid tumor

Time frame
Up to 36 months
3

Pharmacokinetic (PK) detection parameters for HS-IT101

peripheral blood lymphocyte subsets .

Time frame
Up to 6 months
4

Pharmacokinetic (PK) detection parameters for HS-IT101

T-cell receptor (TCR) clonality

Time frame
Up to 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Qingdao Sino-Cell Biomedicine Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: