Health TrialsbyHealthPanel

A Study of GC101 TIL in Advanced Solid Tumors (TR)

ConditionAdvanced Solid Tumors
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Juncell Therapeutics

About this trial

This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy in patients with Advanced malignant solid tumors.Autologous TILs are expanded from tumor resections or biopsies and infused i.v. into the patient after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: 18 years to 75 years;

Histologically diagnosed as primary/relapsed/metastasized malignant tumors;

Expected life-span more than 3 months;

Karnofsky≥60% or ECOG score 0-2;

Disqualifiers

Need glucocorticoid treatment, and daily dose of Prednisone greater than 15mg (or equivalent doses of hormones) or outoimmune diseases requiring immunomodulatory treatment;

Forced expiratory volume in one second (FEV1) less than 2L, diffusing capacity of the lung for carbon monoxide (DLCO) (calibrated) less than 40%;

Significant cardiovascular anomalies according to any of the following definition: New York Heart Association (NYHA) Grade III or IV congestive heart failure, clinically significant low blood pressure, uncontrollable symptomatic coronary artery diseases, or ejection fraction less than 35%; Severe cardiac rhythm and conduction anomaly, such as ventricular arrhythmia requiring clinical intervention, second-third degree atrio-ventricular conductive block, etc.

Human immunodeficiency virus (HIV) infection or anti-HIV antibody positive, active HBV or HCV infection (HBsAg positive and/or anti-HCV positive), syphilis infection or Treponema pallidum antibody positive;

Trial design

Design model

Single group

Treatments tested in this trial

  • Tumor Infiltrating Lymphocytes (TIL)

    Biological/Vaccine

    Biological: Tumor Infiltrating Lymphocytes (TIL) Adoptive transfer of 1x10\^9-5x10\^10 autologous TILs to patients i.v. in 30-120 minutes.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Tumor Infiltrating LymphocytesExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Adverse Events(AE)

To characterize the safety profile of GC101 TIL in patients with recurrent, metastatic, or persistent solid tumor as assessed by incidence of adverse events.

Time frame
6 month
2

Objective Response Rate (ORR)

Proportion of patients with response per Response Evaluation Criteria in Solid Tumors (RECIST v1.1): ORR (proportion of patients) = # with CR + # with PR / # with CR + # with PR + # with SD + # with PD. ( Except baseline evaluation within 28 days before GC101 TIL infusion，PET/CT scan will be performed at 6 weeks after TIL infusion, and than every 6 weeks for 6 months, and then every 6 months after that for up to 3 years)

Time frame
Up to 36 months

Secondary outcomes

1

Disease Control Rate (DCR）

Percentage of patients that meet CR, PR and SD criteria set in this study according to RECIST v1.1： DCR (proportion of patients) = # with CR + # with PR + # with SD / # with CR + # with PR + # with SD + # with PD.

Time frame
Up to 36 months
2

Duration of Response (DOR)

The time length between the first confirmed objective response per RECIST 1.1 to the treatment and the subsequent disease progression per RECIST 1.1

Time frame
Up to 36 months
3

Progression-Free Survival (PFS)

The time length between GC101 TIL infusion and confirmed subsequent disease progression according to RECIST 1.1

Time frame
Up to 36 months
4

Overall Survival (OS)

The length of time from the date of the start of GC101-TIL treatment that the patients are still alive.

Time frame
Up to 36 months

Other outcomes

Sponsors and contacts

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

Shanghai Juncell Therapeutics

Lead sponsor

Shanghai Tong Ren Hospital

Collaborator

Source ClinicalTrials.gov
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