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
NCT ID: NCT07044050
Last Updated: 2025-06-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
10 participants
INTERVENTIONAL
2025-06-10
2026-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cohort 1 (Dose Level 1)
OT-C001 1 vial, weekly dosing
allogenic natural killer cells
OT-C001 will be administered by IV infusion weekly for at least 3 doses.
Cohort 2 (Dose Level 2)
OT-C001 3 vials, weekly dosing
allogenic natural killer cells
OT-C001 will be administered by IV infusion weekly for at least 3 doses.
Cohort -1 (Sub Dose Level)
OT-C001 1/3 vial (100M)
allogenic natural killer cells
OT-C001 will be administered by IV infusion weekly for at least 3 doses.
Interventions
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allogenic natural killer cells
OT-C001 will be administered by IV infusion weekly for at least 3 doses.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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Emercell SAS
INDUSTRY
Responsible Party
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Principal Investigators
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Alain Herrera
Role: STUDY_CHAIR
Emercell SAS
Locations
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Saint-Eloi Hospital
Montpellier, , France
Countries
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Central Contacts
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Facility Contacts
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Cécile LONONGO (POPKO)
Role: primary
Other Identifiers
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C00101
Identifier Type: -
Identifier Source: org_study_id