Diffuse Large B-cell Lymphoma With no Other Specification
Conditions
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.
Interventions
BIOLOGICALallogenic natural killer cells
OT-C001 will be administered by IV infusion weekly for at least 3 doses.
Sponsors
Emercell SAS
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of treatment-emergent adverse events and clinically significant findings on clinical laboratory tests, performance status, vital signs, ECGs, and physical examinations. | All assessments will be conducted from first study treatment administration through the End of Treatment or Early Termination Visit (scheduled within 14 days after the last dose). |
Secondary
| Measure | Time frame |
|---|---|
| Antitumor activity characterized by objective response rate per Lugano criteria. | Tumor will be assessed at the end treatment cycles (3 and 6 weeks after the first dose), and every 12 weeks afterwards for up to of 2 years until progression of disease or starting new anti-cancer treatments. |
Other
| Measure | Time frame |
|---|---|
| Duration of OT-C001 persistence after administering OT-C001. | From baseline (before lymphodepletion) to end of study treatment (within 14 days after the last dose of OT-C001). |
| Changes in serum cytokine levels | From baseline (before lymphodepletion) to end of study treatment (within 14 days after the last dose of OT-C001) |
Countries
France
Contacts
Primary ContactErica Wang
Backup ContactBruno Piccolella
Outcome results
None listed