TAA-Specific CTLS for Solid Tumors (TACTASOM)
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|ClinicalTrials.gov Identifier: NCT02239861|
Recruitment Status : Active, not recruiting
First Posted : September 15, 2014
Last Update Posted : January 13, 2020
This is a clinical trial for patients with a solid tumor which has come back, or may come back, or has not gone away after treatment, including the standard treatment we know for these diseases. This is a study using special immune system cells called tumor-associated antigen (TAA)-specific cytotoxic T lymphocytes, a new experimental therapy.
The proteins that the investigators are targeting in this study are called tumor-associated antigens (TAAs). These are cell proteins that are specific to the cancer cell, so they either do not show or show up in low quantities on normal human cells. In this study, the investigators target five common TAAs called NY-ESO-1, MAGEA4, PRAME, Survivin and SSX. On a different study, patients have been treated and so far this treatment has shown to be safe.
The investigators now want to try this treatment in patients with solid tumors.
This protocol is designed as a Phase I dose-escalation study.
|Condition or disease||Intervention/treatment||Phase|
|Rhabdomyosarcoma||Biological: TAA-Specific CTLs||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Tumor Associated Antigen (TAA)-Specific Cytotoxic T-Lymphocytes Administered to Patients With Solid Tumors|
|Actual Study Start Date :||April 2015|
|Actual Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||December 2024|
Experimental: TAA-Specific CTLs
4 different dosing schedules will be evaluated. 2 to 4 patients will be evaluated on each dosing schedule. The first 2 patients on each dose level will be staggered by 4 weeks (which starts when the first infusion is given, Day 0). No subjects between the ages of 2-18 will be enrolled to a dose level on this protocol, until an adult has been enrolled to and treated on that dose level on one of the protocols being conducted under this same IND. Each patient will receive 2 injections at the same dose,14 days apart: The expected volume of infusion will be 1 to 10 cc.
Dose Level One:
Day 0 and 14: 5 x 10^6 cells/m^2
Dose Level Two:
Day 0 and 14: 1 x 10^7 cells/m^2
Dose Level Three:
Day 0 and 14: 2 x 10^7 cells/m^2
Dose Level Four:
Day 0 and 14: 4 x 10^7 cells/m^2
Biological: TAA-Specific CTLs
Patients may be pre-medicated with Benadryl up to 1 mg/kg IV (max 50 mg) and Tylenol 10 mg/kg po (max 650 mg).
Cell Administration: Tumor-specific T cells will be given by intravenous injection over 1-10 minutes through either a peripheral or a central line.
Patients with stable disease or better will receive up to 6 further doses of CTLs, as long as they continue to show disease stabilization or improvement by RECIST criteria at their 8 week or subsequent evaluations. Each dose will consist of the same number as their second injection or less (if there is not enough product available for the subject's original dose).
Patients will not be able to receive additional doses until the initial safety profile is completed at 6 weeks following the second infusion.
Other Name: Tumor Associated Antigen-Specific Cytotoxic T-Lymphocytes
- Number of patients with dose-limiting toxicity. [ Time Frame: 8 weeks ]The Phase I dose escalation trial is designed for the primary goal of evaluating the safety and feasibility of administering TAA-CTLs to patients with solid tumors.
- Number of patients with a disease response to the CTLs. [ Time Frame: 8 weeks ]The Phase I dose escalation trial is designed for the primary goal of evaluating the safety and feasibility of administering TAA-CTLs to patients with solid tumors.
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): NCT02239861
|United States, Texas|
|Houston Methodist Hospital|
|Houston, Texas, United States, 77030|
|Texas Children's Hospital|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Ann Leen, PhD||Baylor College of Medicine|
|Principal Investigator:||Cliona Rooney, PhD||Baylor College of Medicine|
|Principal Investigator:||Helen Heslop, MD||Baylor College of Medicine|
|Principal Investigator:||Sarah Whittle, MD||Baylor College of Medicine|