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

Recruiting now · Phase 1

Conditions studied: Diffuse Large B-cell Lymphoma With no Other Specification

In brief

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.

Key facts

Study ID

NCT07044050

Run by

Emercell SAS

People needed

10

Starts

2025-06-10

Expected to finish

2026-12-31

Last updated by the study team

2025-06-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥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

You may not qualify if…

• 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
• With rapidly progressing disease that includes massive uncontrolled pleural, pericardial, or peritoneal effusions, pulmonary lymphangitis, and over 50% liver involvement
• 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
• Documented history of active autoimmune disorders requiring systemic immunosuppressive therapy within the last 12 months
• Primary or secondary immune deficiency
• 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

Where it is running

• Saint-Eloi Hospital — Montpellier, France (enrolling)

Full record on ClinicalTrials.gov

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