Actively Recruiting
A First-in-human, Open-label, Clinical Study to Assess the Safety, Tolerability, and Activity of OT-C001 AmplifiedActivated Allogenic Natural Killer Cells in Patients With RelapsedRefractory Diffuse Large B Cell Lymphoma
Led by Emercell SAS · Updated on 2025-06-29
10
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety and appropriate dosing of OT-C001, a type of amplified and activated allogenic natural killer cells, in patients with relapsed or refractory diffuse large B-cell lymphoma who have limited treatment options. This early-phase clinical trial also aims to observe the preliminary activity of OT-C001 in fighting this form of lymphoma. The study is led by Emercell SAS and focuses on patients with evaluable disease and adequate biological conditions. Participants will first receive a short course of chemotherapy before starting OT-C001 treatment. During the treatment phase, they will receive weekly intravenous infusions of OT-C001 for either 3 or 6 weeks, depending on their assigned dose group. Additionally, participants will be given two supporting drugs, rituximab and interleukin-2, as part of the treatment plan. There are different dosing levels being tested, including one vial, three vials, or a sub-dose of OT-C001. Throughout the study, participants will visit the clinic regularly and may need hospitalization based on the study plan. Researchers will monitor safety by assessing adverse events, lab tests, vital signs, ECGs, and physical exams from the start of treatment until shortly after the last dose. They will also evaluate antitumor activity using imaging criteria at the end of treatment cycles and follow participants every 12 weeks for up to two years to track disease progression or new cancer treatments.
CONDITIONS
Brief Title
A First-in-human Study to Assess OT-C001 (Amplified/Activated Allogenic Natural Killer Cells) in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Histologically confirmed diagnosis of relapsed or refractory diffuse large B-cell lymphoma with no further standard treatment options
- Disease that can be evaluated for response
- Adequate biological parameters at the start of the study
- ECOG performance status of 0 or 1
- Life expectancy longer than 3 months as judged by the investigator
You will not qualify if you...
- Receiving any other antitumor-directed drug therapy at the same time
- Vaccination with live virus vaccines before or during treatment
- Severe allergic conditions requiring monoclonal antibodies, allergen immunotherapy, or long-term systemic corticosteroids
- Major surgery within the past 3 weeks
- Rapidly progressing disease with massive uncontrolled fluid buildup in chest, heart, or abdomen, lung involvement, or extensive liver involvement
- Ongoing immune-related toxicities or side effects above grade 1 from previous treatments except certain stable conditions
- Active autoimmune disorders needing systemic immunosuppressive therapy within the past 12 months
- Primary or secondary immune deficiency
- Active, uncontrolled infections needing intravenous antibiotics or antivirals
- Positive for HIV, hepatitis B, or hepatitis C unless cured or vaccinated
- Significant heart disease including heart failure, uncontrolled high blood pressure, arrhythmias, angina, or recent heart attack within 12 months
- Dementia or mental status changes preventing informed consent
- Other cancers within the last 3 years except certain treated skin or cervical cancers or myelodysplastic syndromes
Research Team
E
Erica Wang
B
Bruno Piccolella
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