Anti-GPC3 CAR T for Recurrent or Refractory Lung Squamous Cell Carcinoma
Preliminary Clinical Study of Autologous T Cells Modified Chimeric Antigen Receptor (CAR) Targeting GPC3 for the Treatment of Recurrent or Refractory Lung Squamous Cell Carcinoma
1 other identifier
interventional
20
1 country
1
Brief Summary
The purpose of this study is to observe and confirm the safety, tolerance and cell pharmacokinetics of lentivirus-transduced CAR-GPC3 T cells (CAR-GPC3 T cells targeting GPC3)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Mar 2016
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
August 9, 2016
CompletedFirst Posted
Study publicly available on registry
August 24, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2019
CompletedAugust 24, 2016
August 1, 2016
1.6 years
August 9, 2016
August 23, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Safety and tolerance: Occurrence of study related adverse events
Occurrence of study related adverse events, defined as laboratory toxicities and clinical events that are possibly, likely or definitely related to study treatment at any time from the infusion until week 24. This will include infusive toxicity, and any toxicity possibly related to the CAR-GPC3 T cells.
24 weeks
Secondary Outcomes (1)
Engraftment: the DNA vector copies per mL blood of CAR-GPC3 T cells
2 years
Study Arms (1)
CAR-GPC3 T cells
EXPERIMENTALIntravenous infusion with escalating dose is adopted in this study. Total dosage: 1 x 10\^5 - 2 x 10\^9 CAR-GPC3 T cells/kg The next dose and interval depends on the response of the subject to previous dose. Lymphodepletion: Fludarabine: 30 mg/m\^2/day x 4 days; Cyclophosphamide: 500 mg/m\^2/day x 2 days. Adjustment is in discretion of the investigator based on individual response.
Interventions
Intravenous infusion of CAR-GPC3 T cells is conducted 1 - 2 days following lymphodepletion.
Eligibility Criteria
You may qualify if:
- Men or women aged 18\~70 years old
- Subjects are diagnosed as refractory, recurrent ,metastatic, advanced lung squamous cell carcinoma by histological and cytological methods including specific lesion-targeted brush biopsy, lavage and fine needle aspiration;
- Have at least one new measurable tumor lesion compared with previous irradiated region
- Tumor tissues samples confirmed as GPC3-positive
- Expected survival≥12 weeks
- ECOG scored as 0-1 or KPS grading \> 80
- ANC≥1500/nm3
- PLT≥100000/mm3
- Hb≥9.0g/dL
- Serum creatinine≤2.5mg/dL，CCR≥50ml/min (renal malfunction defined as CCR\<50ml/min according to Cockroft-Gault formula)
- ALT and AST≤2.5ULN; for liver metastasis，ALT and AST ≤5ULN
- Serum TBiL≤3.0mg/dL, TBiL≤2.5ULN
- PT: INR \< 1.7 or extended PT to normal value \< 4s
- Adequate venous access for apheresis or venous blood collection, and no other contraindication of blood cell separation
- Patients with willingness to be in this study and able to provide informed consent
- +2 more criteria
You may not qualify if:
- CAR-T positive rate \< 10%
- pregnant women or women in lactation
- active HBV or HCV infection
- HIV/AIDS infection
- active infection
- previously suffered from diseases or concurrent diseases as followed：
- patients confirmed as severe autoimmune diseases in long-term (over 2 months) need of systemic immune inhibitors (steroid) or as immune-mediated symptomatic diseases including ulcerative colitis, Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus (SLE), autoimmune vasculitis (for example, Wegener's granulomatosis)
- subjects with previous diagnosis as motor neurone disease caused by autoimmunity
- subjects previously suffered from toxic epidermal necrolysis (TEN)
- subjects with any mental diseases including dementia, mental status change that may impinge the understanding and performance of informed consent and related questionnaire
- subjects with severe, uncontrollable diseases judged by investigators that may hinder them receiving this treatment
- subjects with previously active malignant tumors including basal or squamous skin cancer, superficial bladder cancer, and in situ breast carcinoma within 5 years who had been completely cured without the need of follow-up treatment are not excluded.
- during ongoing treatment using systemic steroid or steroid inhalants
- previous treatment used gene therapy products
- previous experience of immunotherapies including CIK, DC, DC-CIK, LAK for the treatment of cancer
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai Chest Hospital,Shanghai Jiaotong University
Shanghai, Shanghai Municipality, 200030, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jiang Liyan, MD
Shanghai Chest Hospital,Shanghai Jiaotong University
Central Study Contacts
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
August 9, 2016
First Posted
August 24, 2016
Study Start
March 1, 2016
Primary Completion
October 1, 2017
Study Completion
April 1, 2019
Last Updated
August 24, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will not share