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Pilot Study of NKG2D CAR-T in Treating Patients With Recurrent Glioblastoma

Sponsor
UWELL Biopharma (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT04717999
Collaborator
(none)
20
Enrollment
1
Arm
28
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This is a pilot phase I study to evaluate the safety and efficacy of NKG2D CAR-T cell therapy in patients with relapsed and/or refractory glioblastoma

Condition or Disease Intervention/Treatment Phase
  • Biological: NKG2D CAR-T
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pilot Study of UWNKG2D CAR-T in Treating Patients With Recurrent Glioblastoma
Anticipated Study Start Date :
Sep 1, 2021
Anticipated Primary Completion Date :
Sep 30, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: UWN2D CAR-T

Biological: NKG2D CAR-T
The NKG2D CAR-T will be administrated via intracerebroventricular injection through an Ommaya catheter. Standard treatments such as temozolomide will be stopped during the infusion of NKG2D CAR-T.
Other Names:
  • UWN2D

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants who experience a Dose-Limiting Toxicity (DLT) [2 years]

      Defined as the dose safely administered Intratumoral for the treatment of patients with GBM

    Secondary Outcome Measures

    1. Overall Response Rate [1 year]

      Defined as the proportion of subjects with overall response of either complete response (CR) or partial response (PR)

    2. Progression-free survival [1 year]

      Defined as date of the first NKG2D CAR-T infusion to the date of disease progression per RANO Response Criteria or death

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Histologically confirmed glioblastoma multiforme (GBM) and are at first or second relapse.

    • Hemoglobin ≥ 9.0 g/dl, absolute neutrophil count (ANC) ≥ 1,000 cells/µl, platelets ≥ 125,000 cells/µl

    • No active infection of HIV, HTLV and Syphilis

    • Adequate renal function

    • Adequate hepatic function

    • Adequate cardiac function

    • Adequate venous access for apheresis, and no other contraindications for leukapheresis

    • Voluntary informed consent is given.

    Exclusion Criteria:

    • Pregnant or lactating women.

    • Uncontrolled active infection.

    • History of hepatitis B or hepatitis C infection.

    • Previously treatment with any gene therapy products or cell therapy product in past 28 days.

    • Cannot undergo MRI with contrast or SPECT/CT

    • HIV infection.

    • Have autoimmune disorders

    • Have active infection or inflammatory disorders

    • Prescreening test results in expansion rate less than 5 folds

    • An allergy to gentamycin and/or streptomycin

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • UWELL Biopharma

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    UWELL Biopharma
    ClinicalTrials.gov Identifier:
    NCT04717999
    Other Study ID Numbers:
    • UBP-P02-3001-GBM
    First Posted:
    Jan 22, 2021
    Last Update Posted:
    Jan 22, 2021
    Last Verified:
    Jan 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Glioblastoma
    Recurrence

    Study Results

    No Results Posted as of Jan 22, 2021