Open Label, Phase 2 Study of CD19 t-haNK and N-803 in Combination with Rituximab in subjects with Relapsed/ Refractory B-cell Non- Hodgkin Lymphoma. 40 Participant will be screened for 20 subjects enrollment.
Participants will receive treatment for a maximum of 12 cycles( 36 weeks) or until they have PD, unacceptable toxicity, withdrawal consent, or if the investigator feels it is no longer their best interest to continue treatment. Participants first receive chemo depletion chemo( Fludarabine and cyclophosphamide) for 3 consensual days, then subjects receive CD19 t-haNK, N-803 and Rituximab every 3 weeks for up to 6 cycles. If participants respond to treatment they will receive maintenance therapy from cycle 7 to 12. All participants should be followed for collection of survival statis, disease status, and posttreatment therapies every 12 weeks(+/- 2 weeks). The follow up visits may occur in-person or via phone contact. Each cycle has day 1 and 8 for treatment. On day one of each cycle the following will be conducted: Concomitant Medication, Physical Exam, Vitals, ECOG and Labs. The participants will receive phone call 6 hours(+/-2) and 24 (+/-4 hours) and 24 post infusion for AE collection during cycle 1.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
N-803 Subcutaneous (SQ): N-803 is a novel IL-15 superagonist immunotherapy administered subcutaneously. It is designed to enhance the proliferation and activation of natural killer (NK) cells and CD8+ T cells without stimulating regulatory T cells. N-803 SQ differs from other cytokine therapies due to its improved pharmacokinetic profile, enhanced in vivo activity, and reduced toxicity. CD19-Directed Therapies: CD19-targeted therapies, are biologic agents specifically designed to recognize and eliminate CD19-expressing B-cell malignancies. These therapies differ from traditional chemotherapy or small molecule inhibitors by leveraging the patient's immune system to achieve targeted cytotoxicity. Their mechanism of action involves direct binding to the CD19 antigen on malignant B cells, leading to immune-mediated cell death.
Dr. Jackie Thomson Inc
Johannesburg, South Africa
RECRUITINGAlbert Cellular Therapy
Pretoria, South Africa
RECRUITINGPrimary Endpoints( Efficacy)
ORR in accordance with Lymphoma Response to Immunomodulatory Therapy Criteria(LYRIC). OS( Time from study treatment initiation to death)
Time frame: 6 months
Secondary endpoints( Safety)
Incidence of treatment- emergent adverse events( TEAEs) and serious adverse event(SAEs) graded using the National Cancer Institute( NCI) CTCAE Version 5.0, Clinically important changes in laboratory.
Time frame: 2 years
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