OT-C001 (amplified/activated donor natural killer cells) for relapsed or refractory diffuse large B‑cell lymphoma
A First-in-human, Open-label, Clinical Study to Assess the Safety, Tolerability, and Activity of OT-C001 (Amplified/Activated Allogenic Natural Killer Cells) in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma
This treatment will try weekly doses of OT-C001 (activated donor natural killer cells) together with rituximab and IL‑2 in adults whose diffuse large B‑cell lymphoma has relapsed or is refractory, to find a safe dose and look for early signs of benefit.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Emercell SAS Industry-sponsored |
| Drugs / interventions | CAR T, immunotherapy, rituximab, chemotherapy |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT07044050 on ClinicalTrials.gov |
What this trial studies
This first-in-human Phase 1 dose-escalation program gives a short course of chemotherapy to prepare patients, then administers weekly doses of OT-C001 for either 3 or 6 weeks alongside rituximab and intermittent low-dose IL‑2 to support NK-cell activity. The primary objective is safety and selection of a recommended dose, with close monitoring of adverse events, laboratory parameters, and pharmacodynamics. Tumor responses and other signs of anti-lymphoma activity are exploratory endpoints to inform later studies. Participants will need frequent clinic visits and may require short hospital stays per the study plan.
Who should consider this trial
Good fit: Adults (≥18 years) with histologically confirmed relapsed or refractory DLBCL‑NOS, evaluable disease, adequate baseline labs, ECOG 0–1, life expectancy >3 months, and no remaining standard treatment options (including those relapsing after or ineligible for CAR‑T) are appropriate candidates.
Not a fit: Patients with rapidly progressing disease involving massive uncontrolled effusions, pulmonary lymphangitis, >50% liver involvement, unresolved immune‑related toxicities >grade 1, recent major surgery, concurrent antitumor therapy, or recent live vaccination are unlikely to benefit or may be ineligible.
Why it matters
Potential benefit: If safe and active, OT‑C001 could provide an off‑the‑shelf immune cell therapy option that shrinks tumors in some patients who have exhausted standard treatments.
How similar studies have performed: Other allogeneic 'off‑the‑shelf' NK‑cell programs have shown early signals of safety and occasional responses in small cohorts, but OT‑C001 as a first‑in‑human agent is novel and unproven.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Montpellier
- Saint-Eloi Hospital — Montpellier, France (Recruiting)
Study contacts
- Study coordinator: Erica Wang
- Email: e.wang@emercell.com
- Phone: 886 921 865 855
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.