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CAR T-cell Therapy

CAR-T Cell Therapy for Hodgkin Lymphoma

Phase 2
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
CrCl > 45 mL/min
Relapsed or refractory cHL that has failed at least 3 prior lines of therapy, including: chemotherapy, BV and/or PD-1 inhibitor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up minimum 24 months post-cd30.car-t infusion
Awards & highlights

Study Summary

This trial will test the safety and effectiveness of a new CAR-T cell therapy for people with Hodgkin Lymphoma that has relapsed or is unresponsive to other treatments.

Who is the study for?
This trial is for individuals aged 12-75 with relapsed or refractory classical Hodgkin Lymphoma, who have tried at least three prior therapies. They must have CD30-positive tumors, measurable lesions, adequate organ function and no severe heart or lung issues. Excluded are those with CNS lymphoma involvement, recent other cancer treatments, active infections like HIV/HBV/HCV, ongoing immunosuppression therapy, certain cardiovascular diseases or pregnancy.Check my eligibility
What is being tested?
The CHARIOT study tests the safety and effectiveness of a personalized immune cell therapy called autologous CD30.CAR-T cells in patients with specific types of Hodgkin Lymphoma that haven't responded to previous treatments. It's an open-label trial where all participants receive the same experimental treatment without a comparison group.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune system activation such as fever and fatigue (cytokine release syndrome), nerve damage symptoms (neurotoxicity), allergic responses to infusion components, blood count changes leading to increased infection risk or bleeding tendencies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney function is good.
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My Hodgkin lymphoma has not improved after 3 treatments including chemotherapy and specific targeted drugs.
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My diagnosis is classical Hodgkin Lymphoma.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My tumor is CD30 positive.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~minimum 24 months post-cd30.car-t infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and minimum 24 months post-cd30.car-t infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pilot: Safety of autologous CD30.CAR-T
Pivotal: Anti-tumor effect of autologous CD30.CAR-T using objective response rate (ORR) as assessed by an Independent Radiology Review Committee (IRRC) per the Revised Criteria for Response Assessment: The Lugano Classification (Cheson, 2014)
Secondary outcome measures
Pilot: Antitumor efficacy of autologous CD30.CAR-T using objective response rate (ORR) as assessed by an Independent Radiology Review Committee (IRRC) per the Revised Criteria for Response Assessment: The Lugano Classification (Cheson et al., 2014)
Pilot: Duration of Response
Pilot: Health Related quality of life (HRQoL) questionnaire
+8 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: CD30 positive r/r classical Hodgkin LymphomaExperimental Treatment3 Interventions
Patients with relapsed or refractory classical Hodgkin Lymphoma who have failed 3 prior lines of treatment, which may include a prior autologous and/or allogeneic stem cell transplant. Patients will be treated with autologous CD30.CAR-T cells.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 3
~1100
Bendamustine
2015
Completed Phase 3
~2950

Find a Location

Who is running the clinical trial?

Tessa TherapeuticsLead Sponsor
3 Previous Clinical Trials
366 Total Patients Enrolled
Helen Heslop, MDPrincipal InvestigatorBaylor College of Medicine
7 Previous Clinical Trials
143 Total Patients Enrolled

Media Library

CD30.CAR-T (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04268706 — Phase 2
Hodgkin's Lymphoma Research Study Groups: CD30 positive r/r classical Hodgkin Lymphoma
Hodgkin's Lymphoma Clinical Trial 2023: CD30.CAR-T Highlights & Side Effects. Trial Name: NCT04268706 — Phase 2
CD30.CAR-T (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04268706 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the most common illnesses that CD30.CAR-T helps to improve?

"CD30.CAR-T is a potential treatment for patients that have waldenstrom macroglobulinemia, refractory mantle cell lymphoma, or chronic lymphocytic leukemia (cll)."

Answered by AI

Who would be an appropriate candidate for this medical research project?

"To qualify for this study, patients must be between 12 and 75 years old, have hodgkin disease, and meet the following additional requirements: being male or female and having at least 1 measurable lesion according to The Lugano Classification."

Answered by AI

Are we currently enrolling people for this research project?

"No, this study is not recruiting at this moment in time. The trial was initially posted on February 1st 2021 but was edited most recently on April 3rd, 2022. There are 2218 other studies that are actively looking for patients right now."

Answered by AI

At how many different facilities can patients sign up for this research project?

"5 centres are recruiting patients for this trial. These locations include City of Hope Comprehensive Cancer Center in Duarte, Sarah Cannon Research Institute in Nashville, the Children's Hospital of Philadelphia in Philadelphia, and 2 other undisclosed sites."

Answered by AI

What are the benefits that researchers hope to achieve from this clinical trial?

"The purpose of this clinical trial, which will last for a minimum of 24 months post-CD30.CAR-T infusion, is to evaluate the anti-tumor effect of autologous CD30.CAR-T using objective response rate (ORR) as assessed by an Independent Radiology Review Committee (IRRC) per the Revised Criteria for Response Assessment: The Lugano Classification (Cheson, 2014). Secondary outcomes include Pilot: Duration of Response which is defined as DOR, Pivotal: Overall Survival which is defined as OS, and Pivotal: Progression Free Survival (PFS) which"

Answered by AI

Would this experimental treatment be suitable for an elderly test subject?

"The age range for people who can participate in this trial are those that are 12 years old or older, but younger than 75."

Answered by AI

Does the FDA sanction CD30.CAR-T for public use?

"CD30.CAR-T falls into the Phase 2 category, meaning that while there is some data supporting its safety, none of it speaks to the medication's efficacy. Therefore, our team at Power gives it a score of 2."

Answered by AI

How many people are being given the chance to participate in this clinical trial?

"Presently, this clinical trial is not looking for new patients to participate. Although, it's worth noting that the study was last edited on April 3rd, 2022 and was originally posted February 1st, 2021. If you're interested in other research studies, there are presently 1768 active trials related to hodgkin disease and 450 CD30.CAR-T studies actively recruiting participants."

Answered by AI

Do CD30.CAR-T studies provide effective treatments?

"At the moment, there are 450 different CD30.CAR-T clinical trials ongoing. Out of those, 42 have reached Phase 3 status. Most of the research is based in Boston, Massachusetts; however, 8575 locations across the globe are conducting similar studies."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Phase 2 Study Evaluating Autologous CD30.CAR-T Cells in Patients With Relapsed/Refractory Hodgkin Lymphoma (CHARIOT)
2021. "Phase 2 Study Evaluating Autologous CD30.CAR-T Cells in Patients With Relapsed/Refractory Hodgkin Lymphoma (CHARIOT)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04268706.
~23 spots leftby May 2025
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