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

  • End date
    Dec 1, 2036
  • participants needed
  • sponsor
    UNC Lineberger Comprehensive Cancer Center
Updated on 22 July 2021


LCCC1852-ATL is a prospective pilot 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).


In this study, investigators will enroll 10 subjects with relapsed/refractory cHL who have previously been treated with 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 HL. Peripheral blood samples will be collected from subjects after consent has been obtained at the time of progression following CD30 CAR-T cell therapy as well as at Day 21 and Day 42 of anti-PD-1 therapy. Investigators will also have access to peripheral blood samples prior to CD30 CAR-T cell therapy, acquired during a prior clinical study. Peripheral blood samples will be immunophenotyped by mass cytometry and T-cell receptor (TCR) sequencing will be pursued to establish expansion of clinically relevant T-cell clones.

The primary objective of this study is to estimate the objective response rate (ORR) of anti-PD-1 therapy after progression on CD30 CAR-T cell therapy in r/r cHL. The secondary objectives will be to measure the change in T-cell receptor clonality during treatment with anti-PD-1 therapy after progression after CD30 CAR-T therapy, the change in peripheral blood immunophenotype during treatment with anti-PD-1 therapy after progression on CD30 CAR-T cell therapy and progression free survival (PFS) of anti-PD-1 therapy after progression on CD30 CAR-T cell therapy.

Preliminary data from subjects treated with anti-PD-1 therapy after progression following CD30 CAR-T cell therapy has suggested surprisingly robust clinical responses to anti-PD-1 therapy. Therefore, this pilot study is an important advancement in our understanding of both immunomodulation after CD30 CAR-T cell therapy as well as clinical response to anti-PD-1 therapy. This study will serve as a baseline for clinical response and immunomodulation for future clinical trials evaluating the combination of anti-PD-1 therapy and CD30 CAR-T cell therapy.

Condition Refractory Hodgkin Lymphoma, Relapsed Hodgkin Lymphoma
Treatment Pembrolizumab, Nivolumab
Clinical Study IdentifierNCT04134325
SponsorUNC Lineberger Comprehensive Cancer Center
Last Modified on22 July 2021


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Inclusion Criteria

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
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 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
Female subject of childbearing potential must agree to use adequate contraception during the study. Adequate contraception is defined by the concomitant use of two effective methods of contraception from the time of informed consent until 150 days after treatment discontinuation. The two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method or an intrauterine device that meets <1% failure rate for protection from pregnancy in the product label. Female subjects of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy or bilateral oophorectomy. Female subjects must refrain from egg cell donation while on study treatment and for at least 150 days after the last dose of investigational product
Male subjects with female partners must have had a prior vasectomy or agree to use an adequate method of contraception (i.e., double barrier method: condom plus spermicidal agent) starting with the first dose of study therapy through 150 days after the last dose of study therapy. Male subjects should agree to refrain from sperm donation while receiving study treatment and for at least 150 days after the last dose of study treatment
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

Subject has history of hypersensitivity reactions to anti-PD-1 therapy
Subject has any contraindication to anti-PD-1 therapy at time of enrollment or inability to be treated with anti-PD-1 therapy for any other reason
Subject has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroids replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic replacement
Subject has evidence of interstitial lung disease or a history of (non-infectious) pneumonitis resulting from previous anti-PD-1 treatment that required steroids or current pneumonitis. History of radiation pneumonitis is not considered a form of non-infectious pneumonitis of concern
Subject has received anti-CD30 CAR-T therapy within the previous 6 weeks
Subject is pregnant or breastfeeding (Note: breast milk cannot be stored for future use while the mother is being treated on the study. Subject must abstain from breastfeeding for 150 days after end of treatment)
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 a live attenuated vaccine within 30 days of initiating study treatment (i.e., 30 days prior to the first dose, during treatment, and for 30 days after study treatment discontinuation). Inactivated vaccines, such as the injectable influenza vaccine, are permitted
Subject has received radiation therapy less than 7 days prior to anti-PD-1 therapy initiation
Subject has had a major surgery within 28 days prior to anti-PD-1 therapy
Subject is not considered to be an acceptable candidate for anti-PD-1 therapy per the treating oncologist's discretion
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