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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 years
Awards & highlights
CARCD30 Trial 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.Check my eligibility
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.See study design
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.
CARCD30 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
CARCD30 Trial 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
To evaluate the safety of escalating doses of autologous EBV-specific cytotoxic T-lymphocytes (CTLs)
Secondary outcome measures
To measure the anti-tumor effects of CAR.CD30 transduced CTLs
To measure the survival of CAR.CD30 transduced EBV-CTLs in vivo.
CARCD30 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
Find a Location
Who is running the clinical trial?
Baylor College of MedicineLead Sponsor
1,002 Previous Clinical Trials
6,002,766 Total Patients Enrolled
Center for Cell and Gene Therapy, Baylor College of MedicineOTHER
111 Previous Clinical Trials
2,799 Total Patients Enrolled
The Methodist Hospital Research InstituteOTHER
275 Previous Clinical Trials
80,527 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have an active infection with HIV, HTLV, HBV, or HCV.I have received rituximab within the last 4 months or my CD19+ B cells are at least 2%.I'm sorry, but I need more specific information about the treatment exclusion criteria in order to provide a simplified explanation. Could you please provide more details?I am currently taking corticosteroids.I have CD30+ lymphoma and cannot complete standard therapy or plan to have a stem cell transplant.My treatment involves a specific immune cell therapy with at least 15% CD30CAR expression.I have Hodgkin's or non-Hodgkin's lymphoma that has come back or didn't respond to treatment, and I'm planning to undergo high dose therapy and stem cell transplantation.It seems like you have provided a heading for inclusion criteria related to treatment. Could you please provide the specific criteria under this heading that you would like me to summarize?My tumor is or might be CD30 positive.My tumor is CD30 positive.I have recovered from the side effects of my last chemotherapy, which was over a month ago.I agree to use effective birth control during and 6 months after the study.You have had allergic reactions to products that contain murine protein.My cancer is CD30 positive.My lung function tests are within the required range.I can care for myself but may need occasional help.I have received anti-CD30 therapy in the last 6 weeks.I am an adult with a disease that did not improve with standard treatments.My tumor is located where it could block my airway if it grows.
Research Study Groups:
This trial has the following groups:- Group 1: autologous CAR.CD30 EBV specific-CTLs
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.
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