CAR T-cell Therapy
Autologous CD30.CAR-T for Hodgkin's Lymphoma
Phase 1
Waitlist Available
Led By Helen Heslop, MD
Research Sponsored by Tessa Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must not have
Timeline
Screening 3 weeks
Treatment Varies
Follow Upthrough study completion, an average of 3 years from leukapheresis
Awards & highlights
No Placebo-Only Group
Study Summary
This trial is testing a new combination therapy for Hodgkin lymphoma that has failed standard treatment. The goal is to see if it is safe and effective.
Eligible Conditions
- Classical Hodgkin's Lymphoma
- Hodgkin's Lymphoma
- Hodgkin's Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 3 years from leukapheresis
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 3 years from leukapheresis
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety of autologous CD30.CAR-T in combination with nivolumab
Secondary outcome measures
Anti-tumor activity using CR rate of autologous CD30.CAR-T in combination with nivolumab
Duration of response
Overall response rate
+1 moreOther outcome measures
Overall survival
Pharmacokinetics - Area under the curve
Pharmacokinetics - Maximum concentration (Cmax)
+1 moreAwards & 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: Nivolumab and CD30.CAR-TExperimental Treatment4 Interventions
Study treatment will include 4 cycles of nivolumab and a single CD30.CAR-T infusion (preceded by lymphodepletion chemotherapy of Fludarabine and Bendamustine).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4120
Fludarabine
2012
Completed Phase 3
~1090
Bendamustine
2015
Completed Phase 3
~2950
Find a site
Who is running the clinical trial?
Tessa TherapeuticsLead Sponsor
3 Previous Clinical Trials
448 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,576 Previous Clinical Trials
4,033,810 Total Patients Enrolled
Helen Heslop, MDPrincipal Investigator
Baylor College of Medicine7 Previous Clinical Trials
225 Total Patients Enrolled
Sairah Ahmed, MDPrincipal Investigator
M.D. Anderson Cancer Center1 Previous Clinical Trials
2 Total Patients Enrolled
Media Library
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the total proposed sample size for this clinical trial?
"The clinical trial is still recruiting patients, as indicated by the information available on clinicaltrials.gov. This study was posted on 7/25/2022 and was updated on 9/27/2022. They are looking for a total of 15 patients that will be split between 5 different sites."
Answered by AI
Is this trial being conducted in different states across America?
"This research is being conducted at Baylor College of Medicine (Houston, TX), UNC Lineberger Comprehensive Cancer Center (Chapel Hill, NC), City of Hope National Medical Center (Duarte, CA), and 5 additional locations."
Answered by AI
Are there risks associated with Autologous CD30.CAR-T treatment?
"Autologous CD30.CAR-T is still in the early stages of development, as Phase 1 trials only provide limited data on efficacy and safety. Therefore, it received a score of 1."
Answered by AI