NCT04193098

Brief Summary

This prospective, unicentric, open-labe phase I study is to evaluate the safety and effect of autologous cytotoxic T lymphocyte immunotherapy combination with PD-1 inhibitor in the second-line treatment of stage IIIB/IIIC/IV non-small cell lung cancer.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_1 nonsmall-cell-lung-cancer

Timeline
Completed

Started Jun 2019

Shorter than P25 for phase_1 nonsmall-cell-lung-cancer

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 10, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

July 7, 2020

Status Verified

July 1, 2020

Enrollment Period

2 years

First QC Date

December 8, 2019

Last Update Submit

July 5, 2020

Conditions

Non-small Cell Lung CancerSecond-line Treatment

Outcome Measures

Primary Outcomes (1)

  • Objective response rate (ORR)

    ORR was calculated by the percentage of patients with a confirmed complete (CR) or partial response (PR).

    2 years

Study Arms (1)

Arm: CTL plus PD-1 inhibitor

EXPERIMENTAL

CTL , Toripalimab Toripalimab intravenous infusion 240mg d1; CTL, 1x10\^9, intravenous infusion,d14; Q3W.

Biological: CTLBiological: Toripalimab

Interventions

CTLBIOLOGICAL

CTL injection

Also known as: Autologous cytotoxic T lymphocyte
Arm: CTL plus PD-1 inhibitor
ToripalimabBIOLOGICAL

Toripalimab injection

Arm: CTL plus PD-1 inhibitor

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects who must meet all the following criteria should be selected:
  • Agreeing to participate in this study and signing a written informed consent.
  • Male or female,from 18 to 75 years (including 18 and 75 years).
  • The life expectancy will be longer than 3 months and can be followed up.
  • Patients with stage IIIB/IIIC/IV NSCLC were confirmed by histological /cytological and imaging examinations. According to RECIST 1.1 standard, there will be at least one measurable lesion.
  • Initial medical treatment.Patients with adenocarcinoma need wild type of EGFR gene and ALK fusion gene negative to be included in this study.
  • ECOG score will be 0 or 1 within 7 days before randomization.
  • Within 14 days before the start of treatment, the results of laboratory test of blood routine, liver, kidney function and hormone levels must be met the following criteria:
  • White blood cells: more than 3.0 × 109/L; Platelets: more than 100 × 109/L; Neutrophils: more than 1.5 × 109/L; Hemoglobin: more than 80g/L; Serum glutamate pyruvate transaminase: less than 2.5 folds of the upper normal limit (ULN); Serum glutamic-oxal (o) acetic transaminase: less than 2.5 × ULN; Serum bilirubin: less than 1.25 × ULN; Serum creatinine: less than 1.25 × ULN. Cortisol and thyroid function will be in the normal range.
  • The toxicity and side effects of previous chemotherapy will must be alleviated to grade 1 or below (except hair loss).
  • Female subjects must take effective contraceptive measures throughout the study period; serum or urine pregnancy test results must be negative during screening and the whole study period.
  • Male subjects should take effective contraceptive measures from the beginning of treatment to within 6 months after the end of treatment.

You may not qualify if:

  • Subjects who meet any of the following criteria could not participate in this study:
  • Adenocarcinoma subjects with EGFR sensitive mutation or ALK translocation; molecular detection of EGFR-sensitive mutations or ALK translocations is not required in squamous carcinoma patients.
  • NSCLC that had received chemotherapy in the past.
  • Other malignant tumors needed treatment within five years.
  • Allogeneic tissue/organ transplantation.
  • Participating in research drug therapy within 4 weeks before the first administration of the trial.
  • Systemic glucocorticoid therapy or any other form of immunosuppressive therapy (except glucocorticoid preconditioned with docetaxel) is being administered within 3 days before the first administration of the experimental therapy.
  • Received anti-tumor monoclonal antibody (mAb), chemotherapy, targeted small molecule therapy or major surgery within 4 weeks before the first use of the drug; received chest radiotherapy greater than 30 Gy within 6 months before the first use of the drug; and received chest radiotherapy with 30 Gy or less within 1 month before the first use of the drug.
  • Previous treatment with PD-1/PD-L1 antibodies.
  • Over the past two years, patients with active autoimmune diseases requiring systemic treatment, such as the use of corticosteroids, or immunosuppressants. Substitution therapy (such as thyroxine, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary dysfunction) is not a systemic treatment.
  • Patients with congenital or acquired immunodeficiency (e.g. HIV-infected persons), active hepatitis B (HBV-DNA \> 10\^3 copies/ml) or hepatitis C (hepatitis C antibody positive), and HCV-RNA higher than the detection limit of the analytical method.
  • Subjects with active central nervous system (CNS) metastases and/or cancerous meningitis.
  • Patients with active infections requiring systemic intravenous therapy. Mental illness or other illnesses, such as uncontrollable heart disease or pulmonary disease, diabetes, etc.
  • Subjects who are known to be allergic to any of the constituents of the drug being studied.
  • Subjects with a recent history of drug abuse (including alcohol) within one year.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

Tianjin Medical University Cancer Institute and Hospital

Tianjin, 300060, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

toripalimab

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Xiubao Ren, M.D, Ph.D

    Tianjin Medical University Cancer Institute and Hospital

    STUDY CHAIR

Central Study Contacts

Xiubao Ren, M.D, Ph.D

CONTACT

86-22-23340123renxiubao@tjmuch.com

Liang Liu, M.D, Ph.D

CONTACT

86-15900243633liangcoh@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2019

First Posted

December 10, 2019

Study Start

June 1, 2019

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

July 7, 2020

Record last verified: 2020-07

Locations

CN(2)