Liver trial: CAR-T (re-engineered T-cells) Hepatic Artery Infusions

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Maia
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Liver trial: CAR-T (re-engineered T-cells) Hepatic Artery Infusions

Postby Maia » Sun Dec 11, 2016 10:18 am

#NCT02850536
Trial not recruting yet. At Rhode Island and Colorado.

I came across this weeks ago and I was hesitant to post, because CAR-T cells are serious business and this sounded new. BUT then, I remembered/ realized THIS trial is a quite well known trial on this forum. It was one of the first immunotherapies tried by patients with mainly liver mets, time ago, at the end of 2012 and 2013. It was usually referred for us at that time as the "Rhode Island liver trial" or "Designer T-Cells trial".
Back then, a couple of persons went for that trial, had CEA lowered, not bad permanent effects but (if memory serves me right) had more tumour burden in other areas and that precluded them from continue. I observe this concerning worries about safety.

The principal investigator is the same, Dr Steven Katz (Roger Williams, Rhode Island), who continued with other trials with CAR-T cells in the meantime. Probably they have refined this protocol a great deal, during these past years.

Three infusions of gene-modified anti-CEA T cells over the course of 3 weeks into the hepatic artery via a percutaneous approach along with low dose IL-2 (interleukin-2).
(anti-CEA CAR-T cells = Gene modified patient T cells = Designer T cells

Detailed Description:
Patients undergo leukapheresis from which peripheral blood mononuclear cells are purified. T cells are activated and then re-engineered to express chimeric antigen receptors (CARs) specific for CEA. Cells are expanded in culture and returned to the patient by percutaneous hepatic artery infusion at specific cell doses. Prior to the first dose, each patient will undergo diagnostic angiography to verify suitable arterial anatomy. Three anti-CEA CAR-T doses per patient are planned at 1-week intervals. Low dose interleukin-2 will be given via an ambulatory infusion pump for 4 weeks.


https://clinicaltrials.gov/ct2/show/NCT02850536

HITM-SURE: “A PHASE Ib TRIAL OF CAR-T HEPATIC ARTERY INFUSIONS DELIVERED WITH THE SUREFIRE INFUSION SYSTEM FOR CEA EXPRESSING LIVER METASTASES”
Principal Investigator: Dr. Steven C. Katz, MD, FACS

Eligibility Criteria:

Tumor must be CEA-expressing demonstrated by elevated CEA level (CEA >10)
Liver metastases must be documented
Failed at least one line of conventional chemotherapy
Good performance status
http://www.weknowcancer.org/research/im ... -protocols


Old discussions on this forum, patients in that trial (well, the old version of that trial):
viewtopic.php?f=1&t=38822&p=296804p296804#p296804
viewtopic.php?f=1&t=38822&p=300970#p300970
viewtopic.php?f=1&t=39935&p=297577

Other ongoing trial, same investigator, anti-CEA CAR-T cells + Sir-Spheres https://clinicaltrials.gov/ct2/show/NCT02416466

KElizabeth
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Location: Omaha

Re: Liver trial: CAR-T (re-engineered T-cells) Hepatic Artery Infusions

Postby KElizabeth » Sun Dec 11, 2016 7:27 pm

Interested. I'll keep it in my pocket for now. Thanks for the information Maia.
Female age 38- ,two kids, age eleven and fifteen.
Colon Cancer - DX March 2013
Age 34 at DX - Stage III B
Resection surgery -May 2013
FOLFOX - June, 2013 to Sept, 2013
5FU plus leukavorin Sept, 2013 to Dec, 2013
METs liver and lungs discovered Sept, 2015
KRAS - MSS
FOLFURI plus Avastin - Sept, 2015 - current
Art therapy January 2015 to current
CEA at recurrence:10.1/august, 2015
CEA: 1.9 February, 2016
CEA:: 10.2 December, 2016
CEA: 40.3 January, 2017
CEA: 16.4 March 2017
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andy21
Posts: 376
Joined: Tue Jun 26, 2012 4:07 pm
Location: N California

Re: Liver trial: CAR-T (re-engineered T-cells) Hepatic Artery Infusions

Postby andy21 » Thu Apr 20, 2017 5:49 pm

My father was part of this trial in Rhode Island.
However, he had severe reaction to interleukin which resulted in a lot of blood loss.
This made his health deteriorate, while the Cancer burden increased.
He passed away in Aug 2013, a month after trial got over.

This process could work for few patients, however if there is a good fit.
Unfortunately, for my dad, that was not the case.
Caregiver: To 67 Yr father
diag. Stage IV, 5/12, liver mets
6 cycles Xelox/Avastin, Start 06/12
Stage 1 of Two Stage Resection Surgery in Dec, 12. 2nd line fails.
T Cell Trial May-Jul, 2013
Becomes a Heavenly Angel in August, 2013


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