Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 (Dose Level 1) | Experimental | OT-C001 1 vial, weekly dosing |
|
| Cohort 2 (Dose Level 2) | Experimental | OT-C001 3 vials, weekly dosing |
|
| Cohort -1 (Sub Dose Level) | Experimental | OT-C001 1/3 vial (100M) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| allogenic natural killer cells | Biological | OT-C001 will be administered by IV infusion weekly for at least 3 doses. |
|
| Measure | Description | 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). |
| Measure | Description | 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. |
| Measure | Description | 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) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erica Wang | Contact | 886 921 865 855 | e.wang@emercell.com | |
| Bruno Piccolella | Contact | +33 6 12 97 73 68 | bruno.piccolella@onward-therapeutics.com |
| Name | Affiliation | Role |
|---|---|---|
| Alain Herrera | Emercell SAS | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint-Eloi Hospital | Recruiting | Montpellier | 34090 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|