NCT04076137

Brief Summary

This is a single-center, open, single-arm controlled prospective clinical trial of patients with solid tumors treated with targeted activation of T cells through intravenous infusion.The purpose of this study was to evaluate the clinical efficacy and safety of targeted activated T cells in the treatment of solid tumors.

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 early_phase_1

Timeline
Completed

Started May 2019

Geographic Reach
1 country

1 active site

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

May 1, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 3, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

September 3, 2019

Status Verified

August 1, 2019

Enrollment Period

1 year

First QC Date

August 29, 2019

Last Update Submit

August 30, 2019

Conditions

Malignant Solid Tumor

Keywords

Targeted T-cellHER2MUC1CEAEGFRGPC3

Outcome Measures

Primary Outcomes (1)

  • OS

    Overrall survival.The time of patient from randomization to death caused by any cause.

    1 year .

Secondary Outcomes (1)

  • PFS

    1 year.

Other Outcomes (4)

  • TTP

    1 year.

  • DCR

    1 year.

  • ORR

    1 year.

  • +1 more other outcomes

Study Arms (1)

Targeted T-cell

EXPERIMENTAL

This study is a pre-phase I immunotherapy trial in 10 people with malignant solid tumor consisting of 9 infusions of bispecific antibody armed anti-CD3-Actibated T cells(ATC) to determine safety, maximum tolerated dose (MTD), technical feasibility, immune responses.

Other: Targeted T-cell armed with bispecific antibody (Decitabine)

Interventions

Targeted T-cell armed with bispecific antibody (Decitabine)OTHER

In this study, 10 patients eligible for the study were clinically screened for intravenous infusion of targeted activated T cells,every participant has a unique identification number and emergency letter which have the information of group.

Also known as: decitabine
Targeted T-cell

Eligibility Criteria

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

You may not qualify if:

  • \. Patients with t-cell lymphoma. 3. Pregnant or lactating female patients, or those who do not want to use contraception during the trial.
  • \. Allergic to both CT and MRI contrast agents and unable to conduct imaging evaluation.
  • \. Other patients in the treated group who were considered as unfit for cell therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of oncology, the second people's hospital of shenzhen

Shenzhen, Guangdong, 518055, China

RECRUITING

MeSH Terms

Interventions

Antibodies, BispecificDecitabine

Intervention Hierarchy (Ancestors)

AntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsAzacitidineAza CompoundsOrganic ChemicalsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Officials

  • Zeqiang Zhou, Doctor

    Department of oncology, the second people's hospital of shenzhen

    STUDY CHAIR

  • Wenli Liang, Doctor

    Department of oncology, the second people's hospital of shenzhen

    STUDY DIRECTOR

  • Liang Xiao, Doctor

    Department of oncology, the second people's hospital of shenzhen

    PRINCIPAL INVESTIGATOR

  • Lin Lin, Doctor

    Department of oncology, the second people's hospital of shenzhen

    PRINCIPAL INVESTIGATOR

  • Meixiang Li, Doctor

    Department of oncology, the second people's hospital of shenzhen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhengzheng Li, Doctor

CONTACT

0755-26912981lizhengcheng07@163.com

Jiana Fan, bachelar

CONTACT

0755-269129811244322047@qq.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Masking Details
targeted activated T-cell
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This is a single-center, open, single-arm controlled prospective clinical study to investigate the efficacy and safety of targeted T-cell therapy in solid tumors.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2019

First Posted

September 3, 2019

Study Start

May 1, 2019

Primary Completion

May 1, 2020

Study Completion

May 1, 2021

Last Updated

September 3, 2019

Record last verified: 2019-08

Locations

CN(1)