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CAR T-cell Therapy

CD30 CAR T-Cells for Lymphoma (CARCD30 Trial)

Phase 1

Waitlist Available

Led By Helen E Heslop, 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

Available autologous transduced EBV-specific cytotoxic T lymphocytes with 15% or more expression of CD30CAR determined by flow-cytometry.

CD30 positive tumor

Must not have

Current use of systemic corticosteroids.

Tumor in a location where enlargement could cause airway obstruction.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests whether combining two ways of fighting disease--antibodies and T cells--can create a more effective way of fighting cancer.

Who is the study for?

This trial is for children and adults with relapsed CD30+ Hodgkin's or Non-Hodgkin's Lymphoma, or those who can't complete standard therapy. Participants must be EBV positive, not pregnant, willing to use effective birth control, have a certain level of blood oxygenation and organ function, and sign informed consent.

What is being tested?

The study tests genetically modified T cells that target lymphoma by combining an anti-CD30 antibody with EBV-specific T cells. This aims to create long-lasting 'chimeric receptor' T cells capable of recognizing and killing lymphoma more effectively than previous treatments.

What are the potential side effects?

Potential side effects are not explicitly listed but may include immune reactions due to the introduction of modified T cells into the body, similar to other cell therapies which can cause fever, fatigue, headache, or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My treatment involves a specific immune cell therapy with at least 15% CD30CAR expression.

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My tumor is CD30 positive.

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I have recovered from the side effects of my last chemotherapy, which was over a month ago.

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My cancer is CD30 positive.

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I can care for myself but may need occasional help.

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I am an adult with a disease that did not improve with standard treatments.

Exclusion Criteria

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

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I am currently taking corticosteroids.

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My tumor is located where it could block my airway if it grows.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

To evaluate the safety of escalating doses of autologous EBV-specific cytotoxic T-lymphocytes (CTLs)

Secondary study objectives

To measure the anti-tumor effects of CAR.CD30 transduced CTLs

To measure the survival of CAR.CD30 transduced EBV-CTLs in vivo.

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: autologous CAR.CD30 EBV specific-CTLsExperimental Treatment1 Intervention

Group One Dose (CTLs CAR.CD30) at Day 0: 2x10\^7 cells/m2 Group Two Dose (CTLs CAR.CD30) at Day 0: 5x10\^7 cells/m2 Group Three Dose (CTLs CAR.CD30) at Day 0: 1x10\^8 cells/m2

0 / 8Eligibility criteria met