Actively Recruiting
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
Led by Emercell SAS · Updated on 2025-06-29
10
Participants Needed
1
Research Sites
81 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 without further standard treatment options including those relapsing after or ineligible for CAR T-cell therapy
- Presence of evaluable disease
- Adequate biological parameters at baseline
- ECOG performance status of 1 or less
- Life expectancy greater than 3 months as assessed by the investigator
You will not qualify if you...
- Receiving any antitumor-directed drug therapy concurrently
- Vaccination with live virus vaccines before or during treatment
- Severe atopic predisposition requiring treatment with monoclonal antibodies, allergen immunotherapy, or long-term systemic corticosteroids
- Major surgery within 3 weeks prior to study
- Rapidly progressing disease with massive uncontrolled pleural, pericardial, or peritoneal effusions, pulmonary lymphangitis, or over 50% liver involvement
- Ongoing immune-related toxicities or adverse events greater than grade 1 not resolved from prior therapies except specific stable conditions
- History of active autoimmune disorders requiring systemic immunosuppressive therapy within the last 12 months
- Primary or secondary immune deficiency
- Active and uncontrolled infections needing intravenous antibiotic or antiviral treatment
- Seropositive for HIV, HBV, or HCV except after vaccination or confirmed cure for hepatitis
- 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 preventing informed consent
- Other malignancy within the last 3 years except treated nonmelanoma skin cancer, in situ uterine cervix carcinoma, or myelodysplastic syndromes
AI-Screening
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Trial Site Locations
Total: 1 location
1
Saint-Eloi Hospital
Montpellier, France, 34090
Actively Recruiting
Research Team
E
Erica Wang
CONTACT
B
Bruno Piccolella
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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