CAR-T Hepatic Artery Infusions and Sir-Spheres for Liver Metastases (HITM-SIR)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02416466|
Recruitment Status : Completed
First Posted : April 15, 2015
Last Update Posted : March 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Liver Metastases||Biological: anti-CEA CAR-T cells Device: Sir-Spheres||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase Ib Trial of CAR-T Hepatic Artery Infusions Followed by Selective Internal Radiation Therapy (SIRT) With Yttrium-90 Sir-Spheres® for CEA-Expressing Liver Metastases|
|Study Start Date :||April 2015|
|Actual Primary Completion Date :||November 21, 2016|
|Actual Study Completion Date :||June 2018|
Experimental: anti-CEA CAR-T cells + Sir-Spheres
Three infusions of gene-modified anti-CEA T cells over the course of 6 weeks into the hepatic artery via a percutaneous approach along with low dose IL-2. A single dose of Sir-Spheres will be given 2 weeks following the final T cell dose.
Biological: anti-CEA CAR-T cells
Gene modified patient T cells.
Other Name: Designer T cells
SIR-Spheres microspheres are a medical device used in Selective Internal Radiation Therapy (SIRT) for liver tumors. SIR-Spheres microspheres are a permanent implant and for single use only. The biocompatible resin microspheres containing yttrium-90 have a median diameter of 32.5 microns (range between 20 and 60 microns).
- Safety of CAR-T cell hepatic artery infusions in combination with Sir-Spheres as Measured by Number of Participants with Adverse Events [ Time Frame: 14 weeks ]To determine the safety and regimen limiting toxicity (RLT) of a standard of care treatment with Yttrium-90 Sir-Spheres Microspheres when following anti-CEA CAR-T hepatic artery infusions (HAI) for CEA-expressing liver metastases.
- Treatment response (Liver tumor response by MRI, PET, CEA level, and biopsy) [ Time Frame: 14 weeks ]
Liver tumor response by MRI, PET, CEA level, and biopsy
- RECIST and immune related response criteria (MRI & PET)
- By evidence of tumor necrosis and fibrosis (biopsy)
- Serum cytokine levels [ Time Frame: 14 weeks ]Measurement of cytokines as indicators of immune response
- CAR-T detection in liver tumors, normal liver, and extrahepatic sites [ Time Frame: 14 weeks ]Quantification of CAR-T cells in biopsy and blood samples
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02416466
|United States, Rhode Island|
|Roger Williams Medical Center|
|Providence, Rhode Island, United States, 02908|
|Principal Investigator:||Steven C Katz, MD||Roger Williams Medical Center|