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Recruiting Phase 1

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

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About this study

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.

Condition
Diffuse Large B-cell Lymphoma With no Other Specification
Tested
allogenic natural killer cells
Sponsor
Emercell SAS

Who can join

Age
18 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 8

  • Minimum age: 18 years
  • Study condition: Diffuse Large B-cell Lymphoma With no Other Specification
  • ≥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 13

  • 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

1 site, 1 recruiting

Saint-Eloi Hospital

Montpellier, France

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.