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CAR T-cell Therapy
CD30 CAR T-Cell Therapy for Lymphoma
Phase 1 & 2
Recruiting
Led By Anne Beaven, 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
Karnofsky or Lansky score of >60% (Karnofsky for pediatric subjects ≥16 years old and Lansky for <16 years old).
Ages 3 to 17 years of age for pediatric subjects (weight must be ≥10kg), and for adults ages ≥18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 years
Awards & highlights
Study Summary
This trial is combining two different ways of fighting disease, antibodies and T cells, in order to create a more effective treatment against cancer.
Who is the study for?
This trial is for adults and children with certain types of lymphoma (HL and NHL) that have returned or resisted treatment. Participants must not be pregnant, should use birth control if applicable, cannot have severe infections like HIV/HCV/HTLV, no recent cancer vaccines or CD30 antibody therapy, and must have good organ function. They also shouldn't be on high-dose steroids or medications that interfere with the chemotherapy drug bendamustine.Check my eligibility
What is being tested?
The study tests ATLCAR.CD30 cells in patients after chemotherapy to find a safe dose and see how well it prevents cancer progression over two years. These are T cells modified with a new gene to target CD30+ lymphoma cells more effectively by using a combination of antibodies and T cell mechanisms.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune system activation such as fever, fatigue, inflammation in various organs due to targeted cell destruction; risk of infection from weakened immune response post-chemotherapy; possible infusion-related reactions when receiving the modified T cells.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can care for myself but may not be able to do active work or play.
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I am either between 3 to 17 years old and weigh at least 10kg, or I am 18 years or older.
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My blood, liver, and kidney functions meet the required levels.
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My tumor is not located where it could block my airway if it grows.
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I am not taking strong CYP1A2 inhibitors like fluvoxamine or ciprofloxacin.
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I do not have any ongoing serious infections.
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I have had hepatitis B but it hasn't reactivated since my initial test.
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My liver, kidneys, and lungs are functioning well according to recent tests.
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My blood counts, liver and kidney functions are within normal ranges, and I can breathe well on my own.
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I haven't had any cancer treatment not required by the study before my second infusion.
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My liver and kidney functions are within normal limits, and I can breathe well on my own.
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I am not pregnant, or I am post-menopausal or have not started menstruating.
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I am mostly able to care for myself and carry out daily activities.
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My kidney function, measured by serum creatinine, is within the required range for my age and gender.
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I can care for myself but may not be able to do active work or play.
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
2 year progression free survival (PFS) after administration of ATLCAR.CD30 in combined adult/pediatric patients with CD30+ refractory/relapsed HL and NHL.
Number of participants with adverse events as a measure of safety and tolerability of ATLCAR.CD30 cells to establish a safe dose after lymphodepletion after lymphodepletion with bendamustine and fludarabine in pediatric patients
Number of participants with adverse events as a measure of safety and tolerability of ATLCAR.CD30 cells to establish a safe dose after lymphodepletion with bendamustine in adult patients
Secondary outcome measures
2 year overall survival (OS) after administration of ATLCAR.CD30 transduced ATl following lymphodepletion with bendamustine in adult patients with CD30+ refractory/relapsed HL and NHL
2 year overall survival (OS) after administration of CAR.CD30 transduced ATL following lymphodepletion with bendamustine and fludarabine in adult and pediatric patients with CD30+ relapsed/refractory HL and NHL.
2 year progression free survival after administration of ATLCAR.CD30 following lymphodepletion with bendamustine and fludarabine in adult and pediatric patients with CD30+ refractory/relapsed HL and NHL.
+13 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: ATLCAR.CD30 cellsExperimental Treatment1 Intervention
Phase Ib: In adults, and separately, in children, two doses will be investigated 1x10^8 cells/m2 and 2x10^8 cells/m^2. The study team will run two independent dose-escalation sequences, one for adults and another one for children. The study team plans to use the 3+3 design and start with a low dose of 1x10^8 cells/m2. If there are no DLT in first 3 patients, the study team will go up to the dose of 2 x 10^8 cells/m2. If there is toxicity in 1/3 patients in the initial cohort, the study team would expand to enroll up to 6 patients. If there are dose limiting toxicities (DLT) at the dose of 2 x 10^8 cells/m^2, the study team will initially decrease the dose to an intermediate dose of 1.5 x 10^8 cells/m^.
Phase II: The study team planning to enroll 31 patients to contribute data. Sequential boundary will be used to monitor DLT rate.
Find a Location
Who is running the clinical trial?
UNC Lineberger Comprehensive Cancer CenterLead Sponsor
351 Previous Clinical Trials
88,293 Total Patients Enrolled
5 Trials studying Immunoproliferative Disorders
161 Patients Enrolled for Immunoproliferative Disorders
Anne Beaven, MDPrincipal InvestigatorDirector, UNC Lineberger Lymphoma Program
4 Previous Clinical Trials
25 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My doctor thinks I am a good candidate for ATLCAR.CD30 treatment.My Hodgkin's or non-Hodgkin's lymphoma has returned after 2+ treatments.I can care for myself but may not be able to do active work or play.My tumor is located where it could block my airway if it grows.I am either between 3 to 17 years old and weigh at least 10kg, or I am 18 years or older.My tumor is located where it could block my airway if it grows.I do not have active Hepatitis B infection.My blood, liver, and kidney functions meet the required levels.My latest scans were done within the required time frame before starting lymphodepletion.I am using two birth control methods or am not having sex to avoid pregnancy during and 6 months after the study.I am taking less than 10mg of steroids daily or using inhaled steroids.My tumor is not located where it could block my airway if it grows.I am not taking strong CYP1A2 inhibitors like fluvoxamine or ciprofloxacin.I do not have any ongoing serious infections.I have had hepatitis B but it hasn't reactivated since my initial test.My liver, kidneys, and lungs are functioning well according to recent tests.My doctor does not recommend CAR T cell therapy for me.I am taking less than 10 mg of prednisone daily or its equivalent, or I am a child on a low-dose steroid.My recent scans show active disease, except for skin lymphoma with small lymph nodes.I do not have an active, poorly controlled HIV, HTLV, or HCV infection.I do not have active Hepatitis B.My blood counts, liver and kidney functions are within normal ranges, and I can breathe well on my own.My blood counts are within safe ranges for treatment.I had chemotherapy within the last 3 weeks before lymphodepletion.I do not have active Hepatitis B.I haven't had any cancer treatment not required by the study before my second infusion.I am not taking medications like fluvoxamine or ciprofloxacin that strongly affect drug metabolism.I am not currently taking high doses of steroids (more than 10 mg of prednisone or equivalent).I am a child taking low-dose steroids or using inhaled steroids.My disease shows CD30 positivity.My cancer is quickly getting worse, according to my doctor.I have not had anti-CD30 antibody therapy in the last 4 weeks.My liver and kidney functions are within normal limits, and I can breathe well on my own.I am not pregnant, or I am post-menopausal or have not started menstruating.You are currently pregnant or breastfeeding.I am mostly able to care for myself and carry out daily activities.My kidney function, measured by serum creatinine, is within the required range for my age and gender.I can care for myself but may not be able to do active work or play.
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.
Is this research actively looking for participants?
"Affirmative. According to the information published on clinicaltrials.gov, this medical trial is actively recruiting patients since 8/26/2016 and was last amended on 12/2/2021. The research team needs 40 volunteers from 1 site in order to finish their study."
Answered by AI
To what extent is the population size of this research endeavor?
"Affirmative. According to information located on clinicaltrials.gov, this research project is currently accepting applicants. The initial post was published August 26th 2016 and the most recent update occurred December 2nd 2021. Forty participants are needed at a single site for this trial to reach completion."
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What overarching goals are researchers striving to accomplish with this trial?
"For this two-year long clinical trial, investigators will assess the safety and tolerability of ATLCAR.CD30 cells through tracking adverse events in participants; alongside evaluating objective response rate, progression free survival after administration of CAR.CD30 transduced ATLs following lymphodepletion with bendamustine and fludarabine for adult/pediatric patients with CD30+ refractory/relapsed HL and NHL; as well as the safety profiles presented by Bendamustine and Fludarabine when used as a lymphodepleting agent prior to infusion."
Answered by AI
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