What side effects are associated with this type of intervention?

Common treatments for Hodgkin's Lymphoma, such as chemotherapy, radiation therapy, and immunotherapy, can have various side effects. Chemotherapy may cause nausea, vomiting, hair loss, and increased risk of infections. Radiation therapy can lead to skin irritation, fatigue, and long-term risks like cardiovascular disease. Immunotherapy, including treatments like TAA-specific Cytotoxic T Lymphocytes (CTLs), can cause immune-related adverse events such as skin rashes, gastrointestinal issues, and endocrine disorders. These side effects arise from the general enhancement of the immune system, which can lead to inflammation in various organs.

What prior FDA approvals exist?

FDA-approved treatments for Hodgkin's Lymphoma that are similar to the TAA-specific Cytotoxic T Lymphocytes (CTLs) being studied include immunotherapies and targeted therapies. Notably, brentuximab vedotin, an antibody-drug conjugate targeting CD30, has been approved for the treatment of Hodgkin's Lymphoma. Additionally, immune checkpoint inhibitors such as nivolumab and pembrolizumab, which target PD-1, have also received FDA approval for relapsed or refractory Hodgkin's Lymphoma. These therapies enhance the body's immune response against cancer cells, similar to the investigational CTLs targeting TAAs.

What other types of research exist?

Promising novel alternatives to TAA-specific CTLs for Hodgkin's Lymphoma patients include checkpoint inhibitors such as nivolumab and pembrolizumab, which target PD-1/PD-L1 pathways to enhance the immune response against cancer cells. Additionally, CAR T-cell therapies, like lisocabtagene maraleucel and axicabtagene ciloleucel, which are engineered to target specific antigens on lymphoma cells, have shown significant efficacy in clinical trials. These therapies represent cutting-edge options for patients considering treatment in 2024.

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CAR T-cell Therapy

TAA-Specific Cytotoxic T-Lymphocytes for Pediatric Lymphoma (pediTACTAL Trial)

Phase 1

Waitlist Available

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

Must not have

Patients with active HIV, Hepatitis B, or Hepatitis C infection at time of procurement

Patients receiving systemic corticosteroids > 0.5mg/kg prednisone or equivalent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new treatment for children with high-risk Hodgkin or non-Hodgkin lymphoma. It uses special white blood cells trained to attack cancer cells. The goal is to see if this treatment is safe and effective in preventing cancer from coming back.

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have active HIV, Hepatitis B, or Hepatitis C.

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I am taking more than a low dose of steroids daily.

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I do not have an active HIV or hepatitis B/C infection.

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I have moderate to severe graft-versus-host disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Treatment-related adverse event (tAE) Rate

Secondary study objectives

Obtain information on the expansion, persistence and anti-tumor effects of the adoptively-transferred TAA-specific CTLs

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Experimental ArmExperimental Treatment1 Intervention

Patients receiving autologous TAA-specific cytotoxic CTLs

0 / 9Eligibility criteria met

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.