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CAR T-cell Therapy
TAA-Specific CTL Therapy for Lymphoma (TACTAL Trial)
Phase 1
Waitlist Available
Led By Geoge Carrum, MD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
PROCUREMENT: Any patient regardless of sex, with a diagnosis of Hodgkin or non-Hodgkin lymphoma
TREATMENT: Patients should have been off conventional therapy for at least 1 week prior to entry in this study, including rituximab
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
TACTAL Trial Summary
This trial is for patients who have a type of lymph gland disease called Hodgkin or non-Hodgkin lymphoma which has come back, or may come back, or has not gone away after treatment. This is a research study using special immune system cells called tumor associated antigen (TAA)-specific cytotoxic T lymphocytes, a new experimental therapy.
Who is the study for?
This trial is for adults and children with Hodgkin or non-Hodgkin lymphoma that has returned after treatment, hasn't responded to treatment, or as a second cancer. Participants need a certain level of hemoglobin, normal organ function tests, and must not be pregnant. They should not have severe infections, HIV, hepatitis B/C infection or be on systemic steroids.Check my eligibility
What is being tested?
The study is testing TAA-specific cytotoxic T lymphocytes (CTLs), which are immune cells designed to target proteins commonly found on lymphoma cells. Some adult patients will also receive azacytidine before the CTLs to potentially enhance the effectiveness of the therapy.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune response such as inflammation in various organs due to targeted cell destruction by CTLs. Azacytidine can cause blood disorders, gastrointestinal symptoms and injection site reactions.
TACTAL Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with Hodgkin or non-Hodgkin lymphoma.
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I haven't received any standard cancer treatments, including rituximab, for at least a week.
Select...
I am 18 or older and have had a stem cell transplant from myself or an identical twin.
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I am under 18 and have an active disease.
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My oxygen level is above 95% without extra oxygen after having radiation therapy.
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I can do most activities but may need help.
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My kidney function, measured by creatinine, is within the normal range for my age.
TACTAL Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assessment of patients with adverse events
Number of Patients with treatment related Serious Adverse Events
Secondary outcome measures
Assessment of increasing the spectrum of epitopes/antigens
Obtain information on the expansion, persistence and anti-tumor effects of the adoptively-transferred TAA-specific CTLs
TACTAL Trial Design
4Treatment groups
Experimental Treatment
Group I: azacytidine and multiTAA T cells StageExperimental Treatment1 Intervention
This phase will administer aza intravenously at a dose of 75 mg/m2 after premedication with an anti-emetic such as ondansetron po or IV (up to a maximum dose of 16 mg ondansetron or equivalent). This phase will determine whether infusion of TAA-specific T cells (at dose level 2 - 1x10^7) targeting multiple tumor antigens in combination with azacytidine is safe, and whether CTL infusions (with or without azacytidine) increase the spectrum of epitopes/antigens targeted by endogenous T cells (epitope spreading).
Group II: Pediatric multiTAA T cells StageExperimental Treatment1 Intervention
This phase will give patients < 18 years old two infusions (on Day 0 and Day 14) of multi-TAA specific T cells at a fixed dose of 1x10^7 cells/m2. This phase will test the safety and efficacy of multiTAA-specific T cells in pediatric patients with active HL/NHL.
Group III: Dose-Escalation Study StageExperimental Treatment1 Intervention
In the dose escalation stage, three dose levels will be studied. Patients in the dose escalation portion of the study will be entered and stratified separately to the following two groups:
Group A: Patients receiving CTLs as therapy for Hodgkin's or non-Hodgkin's lymphoma.
Group B: Patients receiving CTLs as adjunctive therapy following autologous or syngeneic transplant.
Group IV: Antigen-Escalation StageExperimental Treatment1 Intervention
The first stage will be an "antigen-escalation" stage using a fixed total dose of cells (5 x 10^6 cells/m^2 x 2) to evaluate the safety of the T cells primed against PRAME pepmix, and then SSX pepmix, and then MAGE A4 pepmix, and then NY-ESO pepmix, and then SURVIVIN pepmix.
Find a Location
Who is running the clinical trial?
Baylor College of MedicineLead Sponsor
1,001 Previous Clinical Trials
6,002,144 Total Patients Enrolled
Center for Cell and Gene Therapy, Baylor College of MedicineOTHER
111 Previous Clinical Trials
2,781 Total Patients Enrolled
The Methodist Hospital Research InstituteOTHER
271 Previous Clinical Trials
80,339 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with Hodgkin or non-Hodgkin lymphoma.I have been diagnosed with Hodgkin or non-Hodgkin lymphoma.I am currently taking corticosteroids.I am allergic to azacitidine or mannitol.I am currently taking corticosteroids.I am currently dealing with a severe infection.I am not pregnant or breastfeeding.I do not have an active HIV, hepatitis B, or hepatitis C infection.I have not had serious heart problems in the last 6 months.I have advanced liver cancer.I am not pregnant and will use two forms of birth control or have had surgery to prevent pregnancy.I am 18 or older with an active disease.I am 18 or older and have had a stem cell transplant from myself or an identical twin.I am 18 or older with active disease and eligible for azacytidine plus multiTAA-T cell treatment.I am under 18 and have an active disease.My oxygen level is above 95% without extra oxygen after having radiation therapy.I can do most activities but may need help.I haven't received any standard cancer treatments, including rituximab, for at least a week.My kidney function, measured by creatinine, is within the normal range for my age.
Research Study Groups:
This trial has the following groups:- Group 1: Antigen-Escalation Stage
- Group 2: Dose-Escalation Study Stage
- Group 3: azacytidine and multiTAA T cells Stage
- Group 4: Pediatric multiTAA T cells Stage
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any positions currently available for this trial?
"As of the last modification on April 4th 2022, this clinical trial is not actively seeking participants. According to records hosted by clinicialtrials.gov, there are 1957 other studies that remain open for recruitment at present."
Answered by AI
Can you provide a synopsis of prior research involving Antigen-Escalation Stage?
"Presently, 174 Antigen-Escalation Stage trials are in progress. Of those trials, 32 are at the Phase 3 level. While primarily based out of Saint Louis Missouri, these studies have been implemented across 5671 sites worldwide."
Answered by AI
What maladies can be addressed with the Antigen-Escalation Stage approach?
"Antigen-Escalation Stage is the most popular treatment for malignant neoplasms, with it also being beneficial to those suffering from 20-30% blasts, neutropenia and/or thrombocytopenia, as well as anemia."
Answered by AI
What is the highest possible number of participants enrolled in this trial?
"Patient recruitment for this trial is currently inactive. It was initially posted on January 1st 2012 and last modified April 4th 2022. For those exploring alternate clinical trials, there are presently 1783 studies recruiting participants with hodgkin disease and 174 Antigen-Escalation Stage medical experiments searching for candidates."
Answered by AI
What risks do patients undertaking Antigen-Escalation Stage face?
"Our experts at Power gave this Antigen-Escalation Stage a score of 1 since it is only in the first phase of trials - meaning there is restricted information on both its efficacy and safety."
Answered by AI
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