Study of PD-1 Inhibitors After CD30.CAR T Cell Therapy in Relapsed/Refractory Hodgkin Lymphoma

NCT04134325 | Active Not Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: LCCC1852-ATL
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

LCCC1852-ATL is a prospective 2-arm study designed to determine if chimeric antigen receptor T (CAR-T) cells result in immunomodulation which can be subsequently exploited by programmed cell death protein 1 (PD-1) antibodies to achieve clinical responses in subjects with relapsed/refractory (r/r) classical Hodgkin Lymphoma (cHL).

Conditions

Relapsed Hodgkin Lymphoma; Refractory Hodgkin Lymphoma

Keywords

Classic Hodgkin Lymphoma; Relapsed Hodgkin Lymphoma; Refractory Hodgkin Lymphoma; Relapsed/Refractory Hodgkin Lymphoma; CD30; cell therapy; CAR-T; modified T cells; PD-1

Outcome Measures

Primary Outcomes (1)

• Objective response, defined as complete response (CR) or partial response (PR) at 12 weeks after initiating anti-PD-1 therapy

  Response will be determined by the Lymphoma Response to Immunomodulatory Therapy Criteria in order to evaluate the efficacy of anti-PD-1 therapy after progression on CD30 CAR-T cell therapy in relapsed/refractory (r/r) classical Hodgkin Lymphoma (cHL).

  12 weeks

Secondary Outcomes (3)

• Peripheral T-cell receptor frequency per 100,000 clones on Day 1, Day 21, and Day 42 of anti-PD-1 therapy.

  42 days

• Percent change in peripheral blood T-cell subsets

  42 days

• Progression free survival

  From first day of anti-PD-1 therapy to clinical progression or death, up to 15 years

Study Arms (2)

Arm 1: Relapse After Prior CD30 CAR-T Therapy

EXPERIMENTAL

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.

Biological: Nivolumab; Biological: Pembrolizumab

Arm 2: Relapse with no Prior CD30 CAR-T Therapy

EXPERIMENTAL

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.

Biological: Nivolumab; Biological: Pembrolizumab

Interventions

Nivolumab BIOLOGICAL

Nivolumab administered at 240mg every two weeks or 480 mg every four weeks as per standard of care after treatment with CD30.CAR T cells

Also known as: Opdivo

Arm 1: Relapse After Prior CD30 CAR-T Therapy; Arm 2: Relapse with no Prior CD30 CAR-T Therapy

Pembrolizumab BIOLOGICAL

Pembrolizumab administered at 200 mg every three weeks or 400 mg every six weeks as per standard of care after treatment with CD30.CAR T cells

Also known as: Keytruda

Arm 1: Relapse After Prior CD30 CAR-T Therapy; Arm 2: Relapse with no Prior CD30 CAR-T Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• American Society of Clinical Oncology: collaborator

Study Sites (1)

Lineberger Comprehensive Cancer Center at University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Related Links

• UNC Lineberger Comprehensive Cancer Center

MeSH Terms

Conditions

Hodgkin Disease

Interventions

Nivolumab; pembrolizumab

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Natalie Grover, MD

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2019
• First Posted: October 22, 2019
• Study Start: September 1, 2019
• Primary Completion: April 1, 2025
• Study Completion (Estimated): July 7, 2037
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)