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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 below
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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 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

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

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
1,001 Previous Clinical Trials
6,002,206 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

TAA-specific CTLs (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05134740 — Phase 1
Hodgkin's Lymphoma Research Study Groups: Experimental Arm
Hodgkin's Lymphoma Clinical Trial 2023: TAA-specific CTLs Highlights & Side Effects. Trial Name: NCT05134740 — Phase 1
TAA-specific CTLs (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05134740 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Food and Drug Administration (FDA) given its stamp of approval to TAA-specific CTLs?

"Due to limited clinical data regarding the safety and efficacy of TAA-specific CTLs, we have rated its safety as a 1 on our scale."

Answered by AI

Does this research endeavor include elderly participants?

"For this medical investigation, the eligibility requirements state that participants should be aged between 1 and 21. Notably, there are 322 studies for individuals under 18 years of age and 1618 clinical trials available to those over 65."

Answered by AI

What qualifications must potential participants meet to be accepted into this research?

"Those wishing to apply for this research trial must meet the criteria of having lymphoma or hodgkins and be between one year old and twenty-one. This medical investigation has a capacity of 6 participants."

Answered by AI

Are there still openings for participants in this research experiment?

"Affirmative. Clinicaltrials.gov data shows that this research trial, which was first posted on September 4th 2022 and last modified on July 14th 2022, is actively recruiting 6 patients from one location."

Answered by AI

To what extent has participation in this research study been embraced?

"Confirmation, the trial is open for recruitment as seen on clinicaltrials.gov. This research endeavor was first posted on September 4th 2022 and most recently updated July 14th of the same year; looking to enroll 6 individuals from a single location."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
(TAA)-Specific Cytotoxic T-Lymphocytes to Pediatric Patients With Lymphomas (pediTACTAL).
Lauren Scherer 2024. "(TAA)-Specific Cytotoxic T-Lymphocytes to Pediatric Patients With Lymphomas (pediTACTAL).". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05134740.
~4 spots leftby Feb 2025
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