NCT04842812

Brief Summary

Tumor infiltration lymphocytes (TILs) have been harvested from advanced cancer patients and constructed to knockout PD1 gene and express scFvs against both PD1 and CTALA4 and CARs against various antigens, followed by transfusion into the patients. The safety, tolerance, and preliminary clinical efficacy of the TILs will be evaluated.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
105mo left

Started Jan 2021

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress38%
Jan 2021Jan 2035

Study Start

First participant enrolled

January 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 13, 2021

Completed
8.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2035

Last Updated

June 25, 2024

Status Verified

June 1, 2024

Enrollment Period

9 years

First QC Date

April 4, 2021

Last Update Submit

June 22, 2024

Conditions

Liver CancerLung CancerBreast CancerColo-rectal CancerBrain TumorSolid Tumor, AdultPD1CTLA4

Keywords

liver CancerLung CancerSolid TumorTILCAR-TILPD1CTLA4GPC3MesothelinB7-H3CRISPRA-CAS9

Outcome Measures

Primary Outcomes (1)

  • Safety of TILs/CAR-TILs treatment in advanced solid cancers

    Assessing Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.

    up to 36 months

Secondary Outcomes (1)

  • Primary clinical efficacy of the TILs/CAR-TILs treatment in advanced solid cancers

    15 years

Study Arms (1)

TILs/CAR-TILs treatment

EXPERIMENTAL

Obtain TILs/CAR-TILs from advanced solid tumor patients and infuse them back to evaluate safety and clinical efficacy of the treatment.

Biological: TILs and CAR-TILs targeting HER2, Mesothelin, PSCA, MUC1, Lewis-Y, GPC3, AXL, EGFR, Claudin18.2/6, ROR1, GD1, or B7-H3

Interventions

TILs and CAR-TILs targeting HER2, Mesothelin, PSCA, MUC1, Lewis-Y, GPC3, AXL, EGFR, Claudin18.2/6, ROR1, GD1, or B7-H3BIOLOGICAL

TILs and CAR-TILs injection: 1-10Ă—10e7/kg cells for each treatment; 3 or more cycles.

TILs/CAR-TILs treatment

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with advanced cancers that failed to current available therapies;
  • Life expectancy \>12 weeks;
  • Adequate heart, lung, liver, kidney functions;
  • Available for tumor biopsy or cancerous effusions;
  • Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.

You may not qualify if:

  • Had accepted gene therapy before;
  • Severe virus infection such as HBV, HCV, HIV, et al; Known HIV positivity;
  • Active infectious disease related to bacteria, virus, fungi, et al;
  • Other severe diseases that the investigators consider not appropriate;
  • Pregnant or lactating women;
  • Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day);
  • Other conditions that the investigators consider not appropriate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, 510260, China

RECRUITING

MeSH Terms

Conditions

Liver NeoplasmsLung NeoplasmsBreast NeoplasmsColonic NeoplasmsBrain Neoplasms

Interventions

MesothelinPSCA protein, human

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesCentral Nervous System NeoplasmsNervous System NeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

GPI-Linked ProteinsMembrane GlycoproteinsGlycoproteinsGlycoconjugatesCarbohydratesIntracellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsLipid-Linked ProteinsMembrane ProteinsAntigens, SurfaceAntigensBiological Factors

Study Officials

  • Zhenfeng Zhang, MD, PhD

    Second Affiliated Hospital of Guangzhou Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhenfeng Zhang, MD, PhD

CONTACT

+862039195966zhangzhf@gzhmu.edu.cn

Bingjia He, MD

CONTACT

+862039195965464677938@qq.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: TILs treatment of solid cancers
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2021

First Posted

April 13, 2021

Study Start

January 1, 2021

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

January 1, 2035

Last Updated

June 25, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)