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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
OT-C001 will be administered by IV infusion weekly for at least 3 doses.
Saint-Eloi Hospital
Montpellier, France
RECRUITINGIncidence and severity of treatment-emergent adverse events and clinically significant findings on clinical laboratory tests, performance status, vital signs, ECGs, and physical examinations.
Time frame: 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).
Antitumor activity characterized by objective response rate per Lugano criteria.
Time frame: 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.
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