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CAR T-cell Therapy
CAR-T + Nivolumab for Hodgkin Lymphoma (ACTION Trial)
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
Relapsed or refractory CD30+ cHL following failure of a standard frontline chemotherapy
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, or equivalent either Karnofsky performance status (for patients ≥ 16 years of age) or Lansky performance status (for patients < 16 years of age)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 3 years from leukapheresis
Awards & highlights
ACTION Trial 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.
Who is the study for?
This trial is for patients aged 12+ with classical Hodgkin lymphoma (cHL) that didn't respond to standard treatments. They must have at least one lesion visible on PET-CT scans, good organ function, and a performance status indicating they can carry out daily activities with little or no assistance.Check my eligibility
What is being tested?
The study tests a combination therapy of CD30.CAR-T cells and Nivolumab in cHL patients who haven't had success with first-line therapies. It's an early-phase trial assessing the safety and potential effectiveness of this new treatment approach.See study design
What are the potential side effects?
Possible side effects include immune system reactions, infusion-related symptoms, fatigue, changes in blood counts leading to increased infection risk or bleeding tendencies, liver or kidney function alterations, and potential allergic responses.
ACTION Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My Hodgkin lymphoma has returned or didn't respond to initial chemotherapy.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I do not have any active infections, including COVID-19.
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I have at least one cancer lesion visible on a PET-CT scan.
ACTION Trial 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 moreACTION 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
~4750
Bendamustine
2015
Completed Phase 3
~2950
Fludarabine
2012
Completed Phase 3
~1100
Find a Location
Who is running the clinical trial?
Tessa TherapeuticsLead Sponsor
3 Previous Clinical Trials
448 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,485 Total Patients Enrolled
Helen Heslop, MDPrincipal InvestigatorBaylor College of Medicine
7 Previous Clinical Trials
225 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had a serious side effect from previous immunotherapy.You are not currently taking any experimental drugs or tumor vaccines.My blood, kidney, liver, and clotting tests are within normal ranges.I have not had another cancer in the past 3 years.I am not currently receiving any live vaccines.You have previously received experimental treatment with CD30.CAR-T cells.I have had a stem cell transplant for my Hodgkin lymphoma.I do not have any ongoing serious bleeding issues.I have had an autoimmune disease in the last 5 years.I have lung disease that causes symptoms or could affect lung-related side effects from treatment.My Hodgkin lymphoma has returned or didn't respond to initial chemotherapy.I am currently taking drugs that suppress my immune system or long-term steroids.I am fully active or restricted in physically strenuous activity but can do light work.You have had allergic reactions to products that contain murine protein or other ingredients in the past.I have no major side effects from previous treatments.I am allergic or have had bad reactions to nivolumab, fludarabine, or bendamustine.I do not have any active infections, including COVID-19.My lymphoma has spread to my brain or spinal cord.I am 12 years old or older.I have at least one cancer lesion visible on a PET-CT scan.My oxygen levels are below 90% without assistance.I have severe heart problems that limit my daily activities.My heart's pumping ability is below normal.I do not have active seizures, stroke, brain bleeding, dementia, cerebellar disease, or autoimmune disease affecting my brain.
Research Study Groups:
This trial has the following groups:- Group 1: Nivolumab and CD30.CAR-T
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.
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
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