NCT05333588

Brief Summary

The study is to evaluate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy for patients with maligant glioblastoma multiforme. Autologous TiLs should be given by intravenous infusion after 5 days of lymphodepletion treatment.

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
20

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Feb 2022

Typical duration for early_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

February 15, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 19, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2025

Completed
Last Updated

April 19, 2022

Status Verified

April 1, 2022

Enrollment Period

2 years

First QC Date

April 1, 2022

Last Update Submit

April 11, 2022

Conditions

Glioblastoma Multiforme, Adult

Keywords

gliomaTiLsGlioblastoma Multiforme

Outcome Measures

Primary Outcomes (1)

  • Number of adverse events related to TiLs infusion

    The primary outcome measure of this clinical trial is accessed by the safety of the TILs product. The safety profile for TILs is characterized by its incidence of the adverse events.

    1 month

Secondary Outcomes (2)

  • Progressional free of survival (PFS)

    Up to 24 months

  • Objective response rate (ORR)

    24 months

Study Arms (1)

Tumor infiltrating lymphocyte

EXPERIMENTAL

1x10\^9-5x10\^10 of autologous TILs will be adoptive transfer to patients.

Biological: Tumor Infiltrating Lymphocytes (TIL)

Interventions

Tumor Infiltrating Lymphocytes (TIL)BIOLOGICAL

The autologous TILs will be intravenous infused into patients.

Also known as: TILs
Tumor infiltrating lymphocyte

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 18 to 80 years old;
  • Has at least one measurable tumor foci;
  • ECOG score range : 0-2;
  • Expected survival time: ≥ 3 months;
  • All screening labs should be performed 7 days prior to registration.The laboratory results need to meet below criteria:
  • Absolute white blood cell counts (WBC) ≥ 3.0×10\^9/L；
  • Platelet count (PLT) ≥ 100×10\^9/L；
  • Hematological Absolute neutrophil count (ANC) ≥ 1.5×10\^9/L；
  • Hemoglobin (HGB) ≥ 90g/L;
  • Albumin (absolute) ≥ 2.8g/dL;
  • Serum ALT/AST ≤ 2.5×ULN (for patients with liver metastasis ≤ 5×ULN);
  • Total bilirubin (TBIL) ≤ 1.5×ULN (for patients with liver metastasis ≤ 2×ULN);
  • Renal Serum creatinine OR measured or calculated a creatinine clearance (CR) ≤1.5×ULN OR≥ 50 mL/min for participant;
  • AST/ALT (SGOT) ≤ 2.5×ULN (for patients with liver metastasis ≤ 5×ULN);
  • International Normalized Ratio (INR) ≤ 1.5;
  • +3 more criteria

You may not qualify if:

  • Has systemic active infection and requiring treatment;
  • Has severe physical or mental illness;
  • Has active rheumatic disease;
  • Has any kinds of organ transplantation;
  • Being pregnant or lactating;
  • Enrolled in other clinical trials within 4 weeks prior to registration;
  • Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies), active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C;
  • Other conditions that the researcher considered to be excluded;
  • Has taken blow treatment before enrollment:
  • Received systemic immunosuppressive treatments, aside from corticosteroids within 14 days of treatment;
  • Plan to get inactivated vaccine 28 days prior/during, or 60 days post the treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Hospital of HeBei Medical University

Shijiazhuang, Hebei, 050000, China

RECRUITING

MeSH Terms

Conditions

GlioblastomaGlioma

Condition Hierarchy (Ancestors)

AstrocytomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Chunyan Li, academician

    Member of the Chinese Academy of Engineering

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Na Kuang

CONTACT

+8618630160116kuangna@senlangbio.com

Study Design

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

Study Record Dates

First Submitted

April 1, 2022

First Posted

April 19, 2022

Study Start

February 15, 2022

Primary Completion

February 15, 2024

Study Completion

February 15, 2025

Last Updated

April 19, 2022

Record last verified: 2022-04

Locations

CN(1)