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Trial Title:
Autologous CAR T-Cells Targeting the GD2 Antigen for Lung Cancer
NCT ID:
NCT05620342
Condition:
Lung Cancer
Small Cell Lung Carcinoma
Non Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Conditions: Keywords:
cellular therapy
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
iC9.GD2.CAR.IL-15 T Infusion
Description:
iC9-GD2.CAR.IL-15 T-cells product will be administered via intravenous injection over 5 -
10 minutes.
Arm group label:
iC9.GD2.CAR.IL-15 T Therapy
Summary:
This is a phase 1, single-center, open-label study that enrolls adult subjects with
extensive stage lung cancer or stage IV non-small cell lung cancer that is
platinum-refractory and received PD-1 and/or PD-L1 therapy. The purpose of this study is
to test the safety of using a new treatment called autologous T lymphocyte chimeric
antigen receptor cells against the GD2 antigen (iC9-GD2.CAR.IL-15 T cells) in subjects
with lung cancer. How much (dose) of the iC9-GD2.CAR.IL-15 T cells are safe to use
without causing too many side effects and what is the maximum dose that could be
tolerated will be studied.
Modified immune cells as an experimental treatment that combines antibodies and T cells
will be used. Antibodies are proteins that protect the body from foreign invaders like
bacteria. T cells, also called T lymphocytes, are special infection-fighting blood cells
that can kill viruses and other cells, including tumor cells. Although antibodies and T
cells have been used to treat cancer and they both have shown promise, neither alone has
been able to cure most patients. This study will combine T cells and antibodies to create
a more effective treatment.
The treatment that is being researched in this study is called autologous T lymphocyte
chimeric antigen receptor cells targeted against the disialoganglioside (GD2) antigen
that expresses Interleukin (IL)-15, and the inducible caspase 9 safety switch (iC9). The
short name for this treatment is iC9.GD2.CAR.IL-15 T cells therapy is an experimental
therapy and has not been approved by the Food and Drug Administration. There are two
steps. In the first step, blood will be collected from the subjects to prepare the
iC9-GD2.CAR.IL-15 T cells. T cells will be isolated from the blood and modified to make
iC9-GD2.CAR.IL-15. In the second step, the iC9-GD2.CAR.IL-15 T cells produced from the
subject's own blood will be administered to the subject.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Written informed consent to undergo cell procurement explained to, understood by,
and signed by the subject.
2. Subject has a life expectancy of ≥ 12 weeks.
3. Subject must be platinum-refractory and either currently receiving or has previously
received a PD1/PDL1 inhibitor
4. Use of systemic corticosteroids at doses ≥10 mg prednisone daily or it's equivalent;
those receiving <10 mg daily may be enrolled at the discretion of the investigator.
5. Female subjects of childbearing potential must have a negative serum pregnancy test
within 72 hours prior to cell procurement.
6. Subject has demonstrated adequate organ function.
Exclusion Criteria:
1 . Subject has less than 12 weeks of life expectancy.
2. Subject did not receive platinum-based chemotherapy
3. Subject does not have adequate organ function.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Lineberger Comprehensive Cancer Center
Address:
City:
Chapel Hill
Zip:
27514
Country:
United States
Status:
Recruiting
Contact:
Last name:
Catherine Cheng
Phone:
919-445-4208
Email:
UNCImmunotherapy@med.unc.edu
Contact backup:
Last name:
Caroline Babinec
Phone:
919-962-7426
Email:
UNCImmunotherapy@med.unc.edu
Investigator:
Last name:
Jared Weiss, MD
Email:
Principal Investigator
Start date:
June 21, 2023
Completion date:
February 15, 2027
Lead sponsor:
Agency:
UNC Lineberger Comprehensive Cancer Center
Agency class:
Other
Collaborator:
Agency:
Bellicum Pharmaceuticals
Agency class:
Industry
Collaborator:
Agency:
United States Department of Defense
Agency class:
U.S. Fed
Source:
UNC Lineberger Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05620342
http://unclineberger.org/patientcare/clinical-trials/clinical-trials
