Tests allogenic natural killer cells in adults with relapsed diffuse large B-cell lymphoma
Tests OT-C001 immune cells in adults with returning or resistant lymphoma.
Plain-language title generated from the registry record
Registry 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
Key facts
- Where
- Montpellier, FranceSee the site
- Phase
- Phase 1
Where in France
- Saint Eloi HospitalMontpellier, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Emercell SAS
- Trial code
- NCT07044050
- Record updated
- 29 June 2025
- Original description
The goal of this clinical trial is to learn the safety of OT-C001 and decide a good dose in treating relapsed or refractory diffuse large B-cell lymphoma patients. It will also learn about the preliminary activity of OT-C001.Read full original descriptionShow less
A First-in-human, Open-label, Clinical Study to Assess the Safety, Tolerability, and Activity of OT-C001 (Amplified/Activated Allogenic Natural Killer Cells) in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma
The goal of this clinical trial is to learn the safety of OT-C001 and decide a good dose in treating relapsed or refractory diffuse large B-cell lymphoma patients. It will also learn about the preliminary activity of OT-C001.
Participants will:
Receive a short course of chemotherapy before OT-C001 treatment. During the study treatment, participants will recieve weekly dose of OT-C001 for 3 or 6 weeks. During the study period, participants will also receive another two drugs, rituximab and IL-2, to support OT-C001 treatment.
Participants need to visit the clinic or may be hospitalized according to the study plan.
Inclusion: ≥18 years of age; histologically confirmed diagnosis of R/R DLBCL-NOS without further standard treatment options including those relapsing after or ineligible for CAR T-cell therapy; with evaluable disease; with adequate biological parameters at baseline; ECOG performance status ≤1; life expectancy >3 months as assessed by the investigator.
Exclusion: Receive concomitantly any antitumor-directed drug therapy; Any vaccination with live virus vaccines before or during treatment; With severe atopic predisposition who need a treatment with monoclonal antibodies, allergen immunotherapy, or long-term systemic corticosteroids; Major surgery within 3 weeks; Ongoing immune-related tocivities or adverse events grade >1 not resolved from previous therapies except vitiligo, stable neuropathy up to grade 2, hair loss, and stable endocrinopathies with substitutive hormone therapy; With rapidly progressing disease that includes massive uncontrolled pleural, pericardial, or peritoneal effusions, pulmonary lymphangitis, and over 50% liver involvement; Documented history of active autoimmune disorders requiring systemic immunosuppressive therapy within the last 12 months; Active and uncontrolled infections requiring intravenous antibiotic or antiviral treatment; Seropositive (except after vaccination or confirmed cure for hepatitis) for HIV, HBV, or HCV; Clinically significant cardiac disease including heart failure, uncontrolled hypertension, pre-existing arrhythmia, uncontrolled angina pectoris, or myocardial infarction within 12 months; Dementia or altered mental status that would prohibit informed consent; Other malignancy within the last 3 years except adequately treated nonmelanoma skin cancer, in situ carcinoma of the uterine cervix, or myelodysplastic syndromes; Primary or secondary immune deficiency.