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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 years
Awards & highlights
Study 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 belowSelect...
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+.
Select...
My blood tests and heart and lung functions are within normal ranges.
Select...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 15 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 years
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
351 Previous Clinical Trials
88,222 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,843 Previous Clinical Trials
47,817,090 Total Patients Enrolled
Thomas Shea, MDPrincipal InvestigatorDirector, Bone Marrow Transplant Program
2 Previous Clinical Trials
88 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have recurrent Hodgkin lymphoma and will undergo high dose chemotherapy and possibly total body irradiation followed by autologous cell transplantation.I have a specific type of lymphoma that is CD30+.My blood tests and heart and lung functions are within normal ranges.I am mostly able to care for myself but may need occasional help.My condition is considered at high risk of getting worse.My treatment involves modified T cells that meet specific standards.I have received anti-CD30 therapy within the last 4 weeks.I do not have an active infection with HIV, HTLV, HBV, or HCV.I meet the requirements for receiving ATLCAR.CD30 cell therapy.I am using birth control methods.I am currently taking 10mg or more of steroids daily.My tumor is in a spot where it could block my airways if it gets bigger.I am either between 3 to 17 years old or 18 years and older.
Research Study Groups:
This trial has the following groups:- Group 1: ATLCAR.CD30 cells
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any openings for volunteers in this medical experiment?
"The clinicaltrials.gov website states that recruitment for this trial has ended, with the first listing posted on July 15th 2016 and lastly edited on March 2nd 2022. Nonetheless, there are still nearly 5000 other studies actively recruiting patients at this time."
Answered by AI
Has ATLCAR.CD30 cell technology received sanction from the FDA?
"There is limited clinical evidence to support the efficacy and safety of ATLCAR.CD30 cells, so they were assigned a score of 1 on our evaluation scale."
Answered by AI
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