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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

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.Check my eligibility
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.See study design
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.
Select...
My tumor is in a spot where it could block my airways if it gets bigger.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with adverse events as a measure of safety and tolerability of escalating doses of autologous activated T lymphocytes
Secondary outcome measures
Determine the overall survival after infusion of ATLCAR.CD30
Lymphoma
To measure the survival of ATLCAR.CD30 in vivo

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.

Find a Location

Who is running the clinical trial?

UNC Lineberger Comprehensive Cancer CenterLead Sponsor
354 Previous Clinical Trials
91,440 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,854 Previous Clinical Trials
47,817,854 Total Patients Enrolled
Thomas Shea, MDPrincipal InvestigatorDirector, Bone Marrow Transplant Program
2 Previous Clinical Trials
88 Total Patients Enrolled

Media Library

ATLCAR.CD30 cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02663297 — Phase 1
Non-Hodgkin's Lymphoma Research Study Groups: ATLCAR.CD30 cells
Non-Hodgkin's Lymphoma Clinical Trial 2023: ATLCAR.CD30 cells Highlights & Side Effects. Trial Name: NCT02663297 — Phase 1
ATLCAR.CD30 cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02663297 — Phase 1
~2 spots leftby Jul 2025