NCT07044050 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 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Emercell SAS |
| Condition | Diffuse Large B-cell Lymphoma With no Other Specification |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-06-10 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 10 participants in total. It began in 2025-06-10 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * ≥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 Criteria: * 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
Contact & Investigator
Alain Herrera
STUDY CHAIR
Emercell SAS
Frequently Asked Questions
Who can join the NCT07044050 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diffuse Large B-cell Lymphoma With no Other Specification. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07044050 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07044050 currently recruiting?
Yes, NCT07044050 is actively recruiting participants. Contact the research team at e.wang@emercell.com for enrollment information.
Where is the NCT07044050 trial being conducted?
This trial is being conducted at Montpellier, France.
Who is sponsoring the NCT07044050 clinical trial?
NCT07044050 is sponsored by Emercell SAS. The principal investigator is Alain Herrera at Emercell SAS. The trial plans to enroll 10 participants.