New lymphoma drug trial halted early
NCT ID NCT06120504
First seen Jun 27, 2026 · Last updated Jul 07, 2026 · Updated 2 times
Summary
This study tested a new drug, PF-08046045, in 22 adults with advanced lymphomas (cancers of the immune system). The goal was to find a safe dose and check for side effects. The trial was stopped early, so results are limited.
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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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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22 people
The number who actually took part.
- Started
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Feb 2024
- Finished
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Dec 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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: * Disease indication * For dose escalation and dose optimization (Part A and Part B): * Participants with a histologically confirmed lymphoid neoplasm (including relapsed/refractory \[R/R\] classical Hodgkin lymphoma \[cHL\], R/R peripheral T-cell lymphoma \[PTCL\], R/R systemic anaplastic large cell lymphoma \[sALCL\] , R/R mature B-cell neoplasms, and select R/R primary cutaneous lymphomas \[PCLs\]) who in the judgment of the investigator have no appropriate standard therapy available at the time of enrollment and are a candidate for PF-08046045 treatment. * Participants must have a detectable CD30 expression level (≥1%) in tumor tissue (except cHL and ALCL where CD30 is universally expressed). * For dose expansion (Part C) * Participants are eligible irrespective of CD30 expression on tumor tissue. * Participants with cHL: Participants with R/R cHL who have received at least 3 prior systemic therapies (autologous stem cell transplant \[ASCT\] and the associated high dose chemotherapy prior to ASCT are considered to be 1 prior line, along with post-transplant consolidation if progression has not occurred between transplant and start of consolidation) and meet all of the following additional criteria: * Participants who have not received ASCT must have refused or been deemed ineligible. * Participants must have received or been ineligible to receive an anti-PD-1 agent. * Participants with PTCL: * Participants with R/R PTCL (excluding R/R sALCL) who have received at least 2 prior systemic therapies or received at least 1 prior systemic therapy and there is no other available treatment that is considered appropriate by the investigator. * Participants with R/R sALCL must have ALK status documented and must meet one of the following criteria: * Disease recurrence or progression following at least 2 prior systemic therapies where 1 regimen included brentuximab vedotin, or * Disease recurrence or progression following only 1 prior line of therapy which included brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone * An Eastern Cooperative Oncology Group (ECOG) Performance Status score ≤1. * Fluorodeoxyglucose positron emission tomography (FDG PET) avid and bidimensional measurable disease as documented by radiographic technique (spiral CT preferred) per Lugano criteria at baseline (Cheson 2014) (not applicable for subjects with PCL). Exclusion Criteria: * Participants who have received more than 2 prior brentuximab vedotin-based lines of therapy. * History of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death. * Active cerebral/meningeal disease related to the underlying malignancy. * Received previous ASCT infusion \<12 weeks prior to first PF-08046045 dose. * Participants with previous allogeneic stem cell transplant (SCT) if they meet any of the following criteria: * \<100 days from allogeneic SCT. Participants ≥100 days from allogeneic SCT who are stable without immunosuppressive therapy for at least 12 weeks are permitted. * Active acute or chronic graft versus host disease or receiving immunosuppressive therapy as treatment for or prophylaxis against graft versus host disease. * Participants with previous allogeneic SCT and participants considered at high risk for CMV reactivation (eg, recent prior CAR-T or bispecific antibody therapy) if they meet the following criteria: Cytomegalovirus (CMV) PCR ≥500 IU/mL, OR rising DNA levels \>5-times baseline within 1 month, OR detectable CMV PCR receiving pre-emptive therapy; prior PCR positivity that was successfully treated is acceptable provided the baseline PCR result is negative prior to the first dose of study intervention. * Grade 2 or higher pulmonary disease unrelated to underlying malignancy, or history of Grade 2 or higher drug-induced interstitial lung disease (ILD) or immune checkpoint inhibitor (ICI)-related ILD. * Clinically significant lung disease requiring systemic corticosteroid treatment within 6 months prior to enrollment or who are suspected to have such diseases via radiographic imaging and/or functional tests conducted during the screening period.
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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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Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
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Hackensack University Medical Center (From Road)
Paramus, New Jersey, 07652, United States
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Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040, Spain
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MSK Basking Ridge
Basking Ridge, New Jersey, 07920, United States
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MSK Bergen.
Montvale, New Jersey, 07645, United States
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MSK Commack.
Commack, New York, 11725, United States
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MSK Monmouth.
Middletown, New Jersey, 07748, United States
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MSK Nassau.
Uniondale, New York, 11553, United States
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MSK Westchester.
Harrison, New York, 10604, United States
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Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).
New York, New York, 10021, United States
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Memorial Sloan Kettering Cancer Center-Main Campus
New York, New York, 10065, United States
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Stanford Cancer Center / Blood and Marrow Transplant Program
Palo Alto, California, 94304, United States
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The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
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University of Miami
Miami, Florida, 33136, United States
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University of Miami Hospital and Clinics
Miami, Florida, 33136, United States
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University of Miami Hospital and Clinics - Lennar
Coral Gables, Florida, 33146, United States
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