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CAR T-cell Therapy
TAA-Specific Cytotoxic T-Lymphocytes for Pediatric Lymphoma (pediTACTAL Trial)
Phase 1
Recruiting
Led By Lauren Scherer, 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
Patients with a creatinine ≤ 2x upper limit of normal for age
Patients with a Karnofsky/Lansky score of > 60
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
pediTACTAL Trial Summary
This trial is for children with cancer that has come back or does not respond to treatment. The treatment will use T cells that are specific to proteins on the surface of the cancer cells. The purpose of the trial is to see if the T cells are safe and if they have any effect on the cancer.
Who is the study for?
This trial is for pediatric patients aged 1 to 21 with Hodgkin or non-Hodgkin Lymphoma. They must have a Karnofsky/Lansky score over 60, stable organ function, and not be on other investigational therapies for at least one month. Pregnant individuals are excluded, and effective birth control is required during the study.Check my eligibility
What is being tested?
The trial tests TAA-specific cytotoxic T-lymphocytes (CTLs) against lymphoma cells in children who don't have EBV-associated cancer. These CTLs target five specific proteins common in lymphoma cells to see if they're safe and can prevent relapse of the disease.See study design
What are the potential side effects?
While specific side effects aren't listed, potential risks may include immune reactions as CTLs attack cancer cells, infusion-related responses, fatigue from treatment burden, and possible impacts on normal blood cell counts.
pediTACTAL Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function, measured by creatinine, is within twice the normal limit for my age.
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I am mostly able to care for myself but may need occasional help.
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I haven't had conventional therapy or rituximab for a week, or radiation for 4 weeks.
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My oxygen level is above 90% without extra oxygen.
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I am between 1 and 21 years old with Hodgkin or non-Hodgkin Lymphoma.
pediTACTAL Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Treatment-related adverse event (tAE) Rate
Secondary outcome measures
Obtain information on the expansion, persistence and anti-tumor effects of the adoptively-transferred TAA-specific CTLs
pediTACTAL Trial Design
1Treatment groups
Experimental Treatment
Group I: Experimental ArmExperimental Treatment1 Intervention
Patients receiving autologous TAA-specific cytotoxic CTLs
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Hodgkin's Lymphoma include chemotherapy, radiation therapy, and immunotherapy. Chemotherapy uses drugs to kill rapidly dividing cancer cells, while radiation therapy uses high-energy rays to target and destroy cancerous tissues.
Immunotherapy, including the use of TAA-specific Cytotoxic T Lymphocytes (CTLs), leverages the body's immune system to recognize and attack cancer cells. In the case of TAA-specific CTLs, these T cells are engineered to target specific proteins (TAAs) present on the surface of lymphoma cells, leading to the direct killing of these cancer cells.
This approach is particularly promising for Hodgkin's Lymphoma patients as it offers a targeted treatment option that can potentially reduce the risk of relapse and improve outcomes by specifically attacking cancer cells while sparing normal cells.
T-Cell Therapy for Lymphoma Using Nonengineered Multiantigen-Targeted T Cells Is Safe and Produces Durable Clinical Effects.
T-Cell Therapy for Lymphoma Using Nonengineered Multiantigen-Targeted T Cells Is Safe and Produces Durable Clinical Effects.
Find a Location
Who is running the clinical trial?
Baylor College of MedicineLead Sponsor
1,004 Previous Clinical Trials
6,003,268 Total Patients Enrolled
Center for Cell and Gene Therapy, Baylor College of MedicineOTHER
111 Previous Clinical Trials
2,811 Total Patients Enrolled
Lauren Scherer, MDPrincipal InvestigatorBaylor College of Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have active HIV, Hepatitis B, or Hepatitis C.I am using effective birth control or have had a hysterectomy or tubal ligation.My kidney function, measured by creatinine, is within twice the normal limit for my age.I am taking more than a low dose of steroids daily.My organs are functioning well according to tests.My cancer is currently in remission, but there's a high risk it might come back.I do not have an active HIV or hepatitis B/C infection.I am currently taking or have taken steroids within the last week.I am mostly able to care for myself but may need occasional help.I haven't had conventional therapy or rituximab for a week, or radiation for 4 weeks.My oxygen level is above 90% without extra oxygen.I have moderate to severe graft-versus-host disease.I am between 1 and 21 years old with Hodgkin or non-Hodgkin Lymphoma.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental Arm
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.
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