New combo therapy aims to outsmart tough hodgkin lymphoma
NCT ID NCT04134325
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase pilot study is testing whether giving a PD-1 inhibitor (nivolumab or pembrolizumab) after CAR-T cell therapy can help people with relapsed or refractory classical Hodgkin lymphoma. The trial plans to enroll 10 adults whose cancer has not responded to at least three prior treatments. The goal is to see if the combination can shrink tumors and improve immune response.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Nivolumab or Pembrolizumab (PD-1 inhibitors) after CD30-directed CAR-T cell therapy
- What this could lead to
- If successful, this approach could offer a new treatment option for patients with hard-to-treat Hodgkin lymphoma that has not responded to other therapies.
- What could go wrong
- This is a very early, small pilot study with only 10 participants. It may not show clear benefit, and results may not apply to all patients. Side effects from CAR-T and PD-1 inhibitors can be serious.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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10 people
The number who actually took part.
- Started
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Sep 2019
- Expected to finish
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Jul 2037
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria for Arm 1: Relapse After Prior CD 30 CAR-T Therapy * Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information. * Age ≥18 years at the time of consent. * Subject is planned to start on standard of care anti-PD-1 therapy per community standards of medical care by their treating oncologist. * Subject has a diagnosis of relapsed/refractory classical Hodgkin lymphoma after at least three lines of prior therapy with clinical progression after either ATLCAR.CD30 and/or ATLCAR.CD30.CCR4. The CAR-T cell product may be either the UNC, Baylor or Tessa product. * Subjects with prior allogeneic stem cell transplant will be eligible but will be counseled during consent regarding possible increased risk of graft versus host disease with anti-PD-1 therapy after allogeneic stem cell transplant. * Subjects must have previously been treated with anti-PD-1 therapy (any anti-PD-1 therapy either standard of care or investigational) prior to receiving autologous CAR-T-cell therapy. * Subject is willing to provide blood samples that are clinically necessary during anti-PD-1 therapy administered per community standards of medical care. Inclusion Criteria for Arm 2: Relapse with no Prior CD 30 CAR-T Therapy * Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information. * Age ≥18 years at the time of consent. * Subject is planned to start on standard of care anti-PD-1 therapy per community standards of medical care by their treating oncologist. * Subject has a diagnosis of classical Hodgkin lymphoma. * Subjects with prior allogeneic stem cell transplant will be eligible but will be counseled during consent regarding possible increased risk of graft versus host disease with anti-PD-1 therapy after allogeneic stem cell transplant. * Subject is willing to provide blood samples that are clinically necessary during anti-PD-1 therapy administered per community standards of medical care. * Subject is willing and able to comply with study procedures based on the judgment of the investigator or protocol designee. * Subject is willing to consent to study-required blood draws. Exclusion Criteria for Arm 1: Relapse After Prior CD 30 CAR-T Therapy * Subject has received anti-CD30 CAR-T therapy within the previous 6 weeks. * Subject has known active infection with HIV, HTLV, HBV, HCV or any active, uncontrolled infection or sepsis. * Subject has received chemotherapy or anti-PD-1 therapy following CD30 CAR-T cell product administration. * Subject has a known additional malignancy that is active and/or progressive requiring treatment; exceptions include basal cell or squamous cell skin cancer, in situ cervical or bladder cancer, or other cancer for which the subject has been disease-free for at least five years. * Subject is currently using systemic corticosteroids at doses ≥10 mg prednisone daily or its equivalent, or other immunosuppressive medications. Exclusion Criteria for Arm 2: Relapse with no Prior CD 30 CAR-T Therapy * Subject has received anti-CD30 CAR-T therapy * Subject is currently using systemic corticosteroids at doses ≥10 mg prednisone daily or its equivalent, or other immunosuppressive medications.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Lineberger Comprehensive Cancer Center at University of North Carolina
Chapel Hill, North Carolina, 27599, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- PET scans guide Nivolumab-Chemo combo in relapsed hodgkin lymphoma
- Can a weekly drug combo outsmart resistant lymphoma?
- Immunotherapy combo aims to stop hodgkin lymphoma relapse after transplant
- Stem cell transplant study seeks best way to prevent immune attack
- New hope for hodgkin lymphoma: maintenance drug after transplant
- New hope for kids with Hard-to-Treat cancers: targeted drug shows promise