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
NCT07044050 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2025-06-29
Summary
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.
Conditions
- Diffuse Large B-cell Lymphoma With no Other Specification
Interventions
- BIOLOGICAL
-
allogenic natural killer cells
OT-C001 will be administered by IV infusion weekly for at least 3 doses.
Sponsors & Collaborators
-
Emercell SAS
lead INDUSTRY
Principal Investigators
-
Alain Herrera · Emercell SAS
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-06-10
- Primary Completion
- 2026-09-30
- Completion
- 2026-12-31
Countries
- France
Study Locations
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