Off-the-Shelf immune cells take on Hard-to-Treat lymphomas
NCT ID NCT04848064
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This early-phase trial is testing a combination of donor natural killer (NK) cells and the drug mogamulizumab in 12 patients with relapsed or refractory cutaneous T-cell lymphoma or adult T-cell leukemia/lymphoma. The NK cells are grown in the lab and given 'off the shelf' to boost the immune system's ability to attack cancer, while mogamulizumab helps flag cancer cells for destruction. The main goal is to find the safest dose and see if the combination can shrink tumors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- natural killer (NK) cells from healthy donors, combined with mogamulizumab (a monoclonal antibody)
- What this could lead to
- If it works, this could point toward a new treatment option for patients with T-cell lymphomas that have stopped responding to standard therapies.
- What could go wrong
- This is a very early phase I trial with only 12 participants, so it is primarily testing safety and dosing. The combination may not work or could cause serious side effects.
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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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2022
- Expected to finish
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Jan 2027
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: * Able to understand and voluntarily sign an informed consent form * Age \>= 18 years at the time of signing the informed consent form * Able to adhere to the study visit schedule and other protocol requirements * Biopsy-proven, measurable, stage IB-IVB relapsed or refractory cutaneous T-cell lymphoma after 1 prior line of systemic therapy * Note: extracorporeal photopheresis will be considered a systemic therapy for this study * Patients with large cell transformation of cutaneous T cell lymphoma are eligible * Patients with adult T-cell leukemia/lymphoma (ATLL) of any stage and any subtypes. Patient must have had at least one standard chemotherapy and measurable disease at the time of enrollment * Patients who relapsed after autologous or allogeneic stem cell transplant are eligible * All cancer therapy, including radiation, topical steroid, and chemotherapy must have been discontinued at least 1 week or 3 half-lives whichever is the longest prior to treatment in this study. The only exceptions are participants who are symptomatic from their skin lesions and have been on corticosteroids for prolonged periods of time (\> 60 days) without change. These patients may continue use of either systemic steroids (equivalent to \< 10 mg per day of prednisone) or topical steroids if the frequency and dosage steroids has not changed for 21 days prior to the study. These participants should continue on the same dose of systemic/topical steroid throughout the study period unless they achieve a complete response at which time steroids can be tapered or discontinued. Patients are allowed to continue any medications with known activity in T cell lymphomas at the pre-enrollment doses for conditions other than T cell lymphomas (ie, steroids for sarcoidosis), as long as there is evidence of T cell lymphoma progression while patients were on these agents * Eastern Cooperative Oncology Group (ECOG) performance status of =\< 1 at study entry * Absolute neutrophil count \>= 1000/mm\^3 * Platelet count \>= 50,000/mm\^3 * Total bilirubin =\< 2 x upper limit of normal (ULN) * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\]) and Alanine Aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) =\< 3 x ULN * AST (SGOT) and ALT (SGPT) =\< 5 x ULN in patients with documented hepatic involvement by lymphoma * Calculated creatinine clearance \>= 50 ml/min (by the Crockroft-Gault equation) * Disease free of prior malignancies for \>= 2 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix or breast. Patients with early stage of prostate cancer under clinical surveillance without therapy are eligible. Patients with B-cell lymphomas treated with curative intent, and in remission for at least 2 years, may be in included (after discussion with principal investigator \[PI\]) * Negative serum pregnancy test at the time of enrollment for females of childbearing potential. Women who can get pregnant and men with partners who can become pregnant will be asked to practice a highly effective method of birth control while participating in the study that is considered medically acceptable by the study doctor. * Life expectancy \>= 90 days Exclusion Criteria: * Investigational therapies in the 2 weeks prior to beginning treatment on trial * Patients with active central nervous system (CNS) involvement with lymphoma * Patients with known human immunodeficiency virus (HIV) infection with CD4 \< 350 * Patients who had solid organ transplants * Evidence of active hepatitis B infection, based on positive surface antigen or hepatitis B deoxyribonucleic acid (DNA) polymerase chain reaction (PCR), or active hepatitis C infection based on positive PCR. Patients who are hepatitis B core antibody positive must take prophylaxis with lamivudine or equivalent and be willing to undergo monthly hepatitis B DNA PCR testing * Present or history of progressive multifocal leukoencephalopathy (PML) * Active grade II-IV acute or extensive chronic graft versus (vs.) host disease (GVHD) * Patients may take steroids at any dose for disease control up to 24 hours prior to study enrollment. Steroids must have been discontinued at least 1 week or 3 half-lives whichever is the longest prior to treatment in this study, per inclusion criteria above. Topical steroids are allowed for CTCL patients * Any illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety * A cardiovascular disability status of New York Heart Association class \>= 2 * History of severe allergic reactions to humanized monoclonal antibodies * History of other malignancy that could affect compliance with the protocol or interpretation of results. Patients with a history of curatively treated basal or squamous cell carcinoma or Stage 1 melanoma of the skin or in situ carcinoma of the cervix are eligible. Patients with early stage of prostate cancer under clinical surveillance without therapy are eligible * Known hypersensitivity to any of the study drugs or analogs * Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 4 weeks prior study therapy * Clinically significant history of liver disease, including viral or other hepatitis, or cirrhosis * Receipt of live-virus vaccines within 28 days prior to the initiation of study treatment or need for live-virus vaccines at any time during study treatment * Recent major surgery (within 6 weeks prior to the start of study treatment) other than for diagnosis * Receiving immunosuppressive therapy * Prior therapy with mogamulizumab unless stopped previously for reasons other than progression or toxicity. * Pregnant or lactating, or intending to become pregnant during the study
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Study contacts
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Contact
Email: •••••@•••••
Locations
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Ohio State University Comprehensive Cancer Center
RECRUITINGColumbus, Ohio, 43210, United States
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