NCT07125872

Study of Relapsed/ Refractory B-cell Non- Hodgkin Lymphoma

Open Label, Phase 2 Study of CD19 t-haNK and N-803 in Combination With Rituximab in Participants With Relapsed/ Refractory B-cell Non- Hodgkin Lymphoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: ImmunityBio, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Relapsed B-Cell Non Hodgkin Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	CD19 t-haNK- IV Administration	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.

Timeline

• Start date: 2025-11-11
• Primary completion: 2027-05-25
• Completion: 2028-05-25
• First posted: 2025-08-15
• Last updated: 2026-03-16

Locations

2 sites across 1 country: South Africa