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PD-1 Inhibitors + CAR T Cell Therapy for Hodgkin's Lymphoma

Phase < 1
Recruiting
Led By Timothy Voorhees, 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
Age ≥18 years at the time of consent.
Subject has a diagnosis of classical Hodgkin lymphoma.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first day of anti-pd-1 therapy to clinical progression or death, up to 15 years
Awards & highlights

Study Summary

This trial will study if CAR-T cells can be used to treat cHL, and if they can be combined with PD-1 antibodies to improve clinical responses.

Who is the study for?
This trial is for adults over 18 with classical Hodgkin lymphoma that's come back or hasn't responded to treatment. They must have tried at least three prior therapies and either had or not had CD30 CAR-T therapy. Participants need to give informed consent, be ready for standard anti-PD-1 therapy, and provide blood samples.Check my eligibility
What is being tested?
The study is testing if CAR-T cell therapy can make the immune system respond better to PD-1 inhibitors like Nivolumab and Pembrolizumab in patients with relapsed/refractory Hodgkin lymphoma. It has two groups: one previously treated with CD30 CAR-T cells and one without such treatment.See study design
What are the potential side effects?
PD-1 inhibitors may cause fatigue, skin reactions, inflammation of organs (like lungs or intestines), hormonal gland problems, infusion-related reactions, and could potentially worsen graft versus host disease in those who've had a stem cell transplant.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have been diagnosed with classical Hodgkin lymphoma.
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I am starting standard anti-PD-1 therapy as advised by my oncologist.
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I had a stem cell transplant and understand the risks of anti-PD-1 therapy.
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I have been treated with anti-PD-1 therapy before CAR-T-cell therapy.
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My condition relapsed and I haven't had CD30 CAR-T therapy before.
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I have Hodgkin lymphoma that didn't respond to at least 3 treatments, including specific CAR-T therapies.
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I am willing to give blood samples for my anti-PD-1 therapy.
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My cancer returned after CD30 CAR-T cell therapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first day of anti-pd-1 therapy to clinical progression or death, up to 15 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first day of anti-pd-1 therapy to clinical progression or death, up to 15 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective response, defined as complete response (CR) or partial response (PR) at 12 weeks after initiating anti-PD-1 therapy
Secondary outcome measures
T-Lymphocyte Subsets
Peripheral T-cell receptor frequency per 100,000 clones on Day 1, Day 21, and Day 42 of anti-PD-1 therapy.
Progression free survival

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm 2: Relapse with no Prior CD30 CAR-T TherapyExperimental Treatment2 Interventions
Subjects with relapsed/refractory classical Hodgkin lymphoma (r/r cHL) who have previously progressed on anti-PD-1 therapy, have not received a CD30 CAR-T cell therapy and have evidence of progression. Subjects will be offered anti-PD-1 therapy (nivolumab or pembrolizumab, at the discretion of treating oncologist), as per standard of care in r/r cHL.
Group II: Arm 1: Relapse After Prior CD30 CAR-T TherapyExperimental Treatment2 Interventions
Subjects with relapsed/refractory classical Hodgkin lymphoma (r/r cHL) who have previously progressed on anti-PD-1 therapy, have received a CD30 CAR-T cell therapy and have evidence of progression. Subjects will be offered anti-PD-1 therapy (nivolumab or pembrolizumab, at the discretion of treating oncologist), as per standard of care in r/r cHL.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

UNC Lineberger Comprehensive Cancer CenterLead Sponsor
348 Previous Clinical Trials
88,151 Total Patients Enrolled
American Society of Clinical OncologyOTHER
33 Previous Clinical Trials
147,533 Total Patients Enrolled
Timothy Voorhees, MDPrincipal InvestigatorClinical Fellow

Media Library

Pembrolizumab Clinical Trial Eligibility Overview. Trial Name: NCT04134325 — Phase < 1
Hodgkin's Lymphoma Research Study Groups: Arm 1: Relapse After Prior CD30 CAR-T Therapy, Arm 2: Relapse with no Prior CD30 CAR-T Therapy
Hodgkin's Lymphoma Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT04134325 — Phase < 1
Pembrolizumab 2023 Treatment Timeline for Medical Study. Trial Name: NCT04134325 — Phase < 1

Frequently Asked Questions

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

To what ailments is Pembrolizumab usually prescribed?

"Commonly used to address unresectable melanoma, pembrolizumab can also be administered as a treatment for microsatellite instability high and squamous cell carcinoma with an elevated risk of recurrence."

Answered by AI

What is the upper limit of participants for this experiment?

"Affirmative. The records on clinicaltrials.gov signify that this trial is recruiting volunteers, which was initially posted on September 1st 2019 and recently updated July 22nd 2022. 20 participants are sought for the study at a single location."

Answered by AI

Is the recruitment of participants still open for this trial?

"Affirmative. Clinicaltrials.gov verifies that this research project, which was posted in September 2019 and recently revised on July 22nd 2022 is actively recruiting patients for participation. Up to 20 individuals are needed between 1 trial site."

Answered by AI

Have there been prior experiments utilizing Pembrolizumab?

"Currently, there are 1633 active studies involving Pembrolizumab - with 200 in the final stage of trials. The majority are taking place in Houston, Texas; however, this cancer treatment is being researched from over 73 thousand different facilities worldwide."

Answered by AI
~4 spots leftby Apr 2025