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CAR T-cell Therapy

T Lymphocyte Therapy for Lymphoma

Phase 1

Waitlist Available

Led By Thomas Shea, MD

Research Sponsored by UNC Lineberger Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of recurrent Hodgkin lymphoma with a treatment plan including high dose chemotherapy with/without total body irradiation and autologous cell transplantation

Non-Hodgkin lymphoma patients meeting specific criteria for CD30+ anaplastic large-cell lymphomas, high-risk DLBCL, cutaneous T cell lymphoma, or mycosis fungoides

Must not have

Active infection with HIV, HTLV, HBV, HCV

Current use of systemic corticosteroids at doses ≥10mg/day prednisone or its equivalent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new way to fight cancer by combining T cells and antibodies. Researchers want to see if it's safe and if it has any side effects.

Who is the study for?

This trial is for patients with certain types of lymphoma, including Hodgkin's and Non-Hodgkin's, who are eligible for a transplant. Participants should have CD30+ cancer cells, be over 3 years old, have good heart and lung function, and not be pregnant or breastfeeding. They must agree to use two forms of birth control if applicable.

What is being tested?

The study tests ATLCAR.CD30 cells in patients post-transplant to prevent relapse of lymphoma. These are T cells modified with a new gene making them better at recognizing and killing cancer cells by targeting the CD30 antigen found on some lymphoma cells.

What are the potential side effects?

Potential side effects may include reactions related to the immune system attacking normal tissues (autoimmune reactions), symptoms from cell infusions such as fever or chills, and an increased risk of infections due to the modification of T cells.

Eligibility Criteria

Inclusion Criteria

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

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I have recurrent Hodgkin lymphoma and will undergo high dose chemotherapy and possibly total body irradiation followed by autologous cell transplantation.

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I have a specific type of lymphoma that is CD30+.

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My blood tests and heart and lung functions are within normal ranges.

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I am mostly able to care for myself but may need occasional help.

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My treatment involves modified T cells that meet specific standards.

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I am either between 3 to 17 years old or 18 years and older.

Exclusion Criteria

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

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I do not have an active infection with HIV, HTLV, HBV, or HCV.

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I am currently taking 10mg or more of steroids daily.

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My tumor is in a spot where it could block my airways if it gets bigger.

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

Number of participants with adverse events as a measure of safety and tolerability of escalating doses of autologous activated T lymphocytes

Secondary study objectives

Determine the overall survival after infusion of ATLCAR.CD30

Lymphoma

To measure the survival of ATLCAR.CD30 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: ATLCAR.CD30 cellsExperimental Treatment1 Intervention

Three dose levels of ATLCAR.CD30 cells will be evaluated. Using the modified continual reassessment method (CRM), initial cohort of size two will be enrolled at each dose level after that subjects are enrolled one at a time until a minimum of 12 patients is treated. Each patient will receive one injection according to the dosing schedules listed below. Investigators will start with the lowest cell dose (2X10\^7 cells/m\^2) given to patients in one of our previous trials employing CAR-T cells including the CD28 costimulatory endodomain, and investigators will escalate the cell dose to the highest cell dose (2X10\^8/m\^2) given in the same trial. Note: Initially, only adults will be enrolled during the dose escalation phase of the study. Once a dose level has been tested in at least 2 adults without the occurrence of dose limiting toxicities (DLTs), children may then be enrolled on that dose level according to the CRM.

0 / 9Eligibility criteria met