NCT03638206

Brief Summary

This is a single arm, open-label, uni-center, phase I-II study to evaluate the safety and effectiveness of CAR-T/TCR-T cell immunotherapy in treating with different malignancies patients.

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
73

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2018

Longer than P75 for phase_1

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

March 1, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 20, 2018

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

December 11, 2019

Status Verified

December 1, 2019

Enrollment Period

5 years

First QC Date

August 16, 2018

Last Update Submit

December 10, 2019

Conditions

Esophagus CancerB-cell Acute Lymphoblastic LeukemiaLymphomaMyeloid LeukemiaMultiple MyelomaHepatomaGastric CancerPancreatic CancerMesotheliomaColorectal CancerLung CancerGliomaMelanomaSynovial SarcomaOvarian CancerRenal Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Adverse Events evaluated with NCI CTC AE, version 4.0

    Safety evaluation

    60 months

Secondary Outcomes (2)

  • Clinical response

    60 months

  • CAR-T cells testing

    60 months

Study Arms (1)

CAR-T cell immunotherapy

EXPERIMENTAL

Enrolled patients will receive CAR-T cell immunotherapy with several different specific Chimeric antigen receptors aiming at different antigens respectively by infusion.

Biological: CAR-T cell immunotherapy

Interventions

CAR-T cell immunotherapyBIOLOGICAL

According to tumor burden and other conditions, patients will be treated with cyclophosphamide or fludarabine,then,CAR-T cells will be infused 48-72 hours later.

CAR-T cell immunotherapy

Eligibility Criteria

Age4 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • If patients had receive immunotherapy, they should reach PR/NR, or recurrency.
  • Patients must be willing to sign an informed consent.
  • age: 4 to 70 years
  • Estimated survival of ≥ 12 weeks, but ≤ 2 years
  • Blood tumor or solid tumor was diagnosed by histopathology.Positive expression of CD19, CD22, CD33, CD38, BCMA, NY-ESO-1, c-met, Mesothelin, CEGFRvIII and DR5 was confirmed by biopsy IHC test or flow cytometry test. If NY-ESO-1 is positive expression ,positive HLA-A\*0201 is required at the same time .
  • Subjects with solid tumor must have measureable disease
  • Routine blood test：hemoglobin\>=90 g/L; platelet\>=50×10\^9/L.
  • Renal function:BUN: 9-20mg / dl; serum creatinine\<= 1.5 times upper limits of normal; endogenous creatinine clearance rate\>=50 ml/min
  • Negative serum antibody for EBV, CMV, HIV , syphilis, HBVa nd HCV(patients with liver cancer were excluded)
  • Cardiac function: stable hemodynamic and left ventricular ejection fraction (LVEF)\>=55%.
  • ECOG score ≤2
  • Adequate venous access for apheresis, and no other contraindications for leukapheresis
  • Women of child-bearing age must have evidence of negative pregnancy test.
  • Subjects of reproductive potential must agree to use acceptable birth control methods within 1 year after treatment, as described in protocol.

You may not qualify if:

  • ECOG \>= 3
  • Patients with history of T cell tumors
  • Patients with severe insufficient cardiac, pulmonary and hepatorenal functions
  • Acute or chronic GVHD after allogeneic hematopoiesis
  • steroid hormoneswere used before and after blood collection and infusion
  • HIV infection or active hepatitis B or hepatitis C infection
  • Uncontrolled active infection
  • Enrolled to other clinical study in the last 4 weeks.
  • Subjects with systemic auto-immune disease or immunodeficiency.
  • Subjects with CNS diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

RECRUITING

MeSH Terms

Conditions

Burkitt LymphomaLymphomaLeukemia, MyeloidMultiple MyelomaCarcinoma, HepatocellularStomach NeoplasmsPancreatic NeoplasmsMesotheliomaColorectal NeoplasmsEsophageal NeoplasmsLung NeoplasmsGliomaMelanomaSarcoma, SynovialOvarian NeoplasmsCarcinoma, Renal Cell

Interventions

Immunotherapy, Adoptive

Condition Hierarchy (Ancestors)

Epstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLymphoma, Non-HodgkinNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemiaHematologic DiseasesNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesGastrointestinal NeoplasmsGastrointestinal DiseasesStomach DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System DiseasesAdenomaNeoplasms, MesothelialIntestinal NeoplasmsColonic DiseasesIntestinal DiseasesRectal DiseasesHead and Neck NeoplasmsEsophageal DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueNeuroendocrine TumorsNevi and MelanomasSkin NeoplasmsSkin DiseasesSkin and Connective Tissue DiseasesNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueSarcomaOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesGonadal DisordersKidney NeoplasmsUrologic NeoplasmsKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Adoptive TransferImmunization, PassiveImmunizationImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative Techniques

Central Study Contacts

ZhongHua Yang

CONTACT

18938688105zh.yang@bindebio.com

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 16, 2018

First Posted

August 20, 2018

Study Start

March 1, 2018

Primary Completion

March 1, 2023

Study Completion

March 1, 2023

Last Updated

December 11, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)