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A Study of GC203 TIL in Advanced Solid Tumors (NF)

ConditionSolid Tumors, Adult
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Juncell Therapeutics

About this trial

This study is a prospective, open-label, single-arm clinical trial aimed at evaluating the safety and efficacy of GC203 TIL therapy in treating malignant solid tumors that have failed standard treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

have one the tumor resection for gene-edited GC203 TIL production and successfully produced；

Age: 18 years to 75years;

Histologically diagnosed as solid tumor;

Expected life-span more than 3 months;

Disqualifiers

with other malignant tumors,except for the malignancies that have been cured, have been inactive for ≥5 years prior to study inclusion and have a very low risk of recurrence; Non-melanoma skin cancer or malignant lentigo with adequate treatment and no evidence of disease recurrence; Carcinoma in situ with adequate treatment and no evidence of disease recurrence;

Need glucocorticoid treatment, and daily dose of Prednisone greater than 10mg(or equivalent doses of hormones) or outoimmune diseases requiring immunomodulatory treatment;

Breathe indoor air in a quiet state, and the oxygen saturation of finger pulse is < 95%;

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

  • GC203 TIL

    Biological/Vaccine

    A tumor sample is resected from each participant and cultured ex vivo to expand the population of engineered tumor infiltrating lymphocytes injection (GC203 TIL). After lymphodepletion, patients are infused GC203 TIL.

Treatment groups

8 Participants
are divided into 1 treatment group
Group A: GC203 TILExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Adverse Events

To characterize the safety profile of GC203 TIL in patients with Solid Tumors who were failed to standard treatment as assessed by incidence of adverse events.

Time frame
6 month

Secondary outcomes

1

Objective Response Rate (ORR)

Proportion of patients with response per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

Time frame
Up to 36 months
2

Disease Control Rate (DCR）

Proportion of patients with response per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

Time frame
Up to 36 months
3

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
4

Progression-Free Survival (PFS)

The time from TIL infusion until disease progression or death from any cause.

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

Shenzhen Hospital of Southern Medical University

Collaborator

Source ClinicalTrials.gov
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