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Also known as CD19 t-haNK- IV Administration, CD19 t-haNK- Administration, CD19t-haNK suspension, Rituximab
CD19 t-haNK · 3 trials · 3 indications
ORR in accordance with Lymphoma Response to Immunomodulatory Therapy Criteria(LYRIC). OS( Time from study treatment initiation to death)
Safety will be assessed for all participants and will include vital signs, physical examinations, clinical labs (hematology, chemistry panel, pregnancy tests), cytokine levels, electrocardiograms, neurological assessments, and the incidence and severity of adverse events (AEs) graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. All participants will receive follow-up phone calls 6 hours (± 1 hour) and 24 hours (± 2 hours) post infusion for AE collection during Cycle 1
The incidence of TEAEs and SAEs will be presented by System Organ Class and Medical Dictionary for Regulatory Activities (MedDRA) preferred term. All AEs will be graded using CTCAE Version 5.0 except for CRS and ICANS, which will be graded using ICE score. The incidence of clinically important changes in safety laboratory tests and vital signs will also be presented.
| Arm | Type | Description |
|---|---|---|
| Open Label- Single Arm | OTHER | Open label: combination of Rituximab and investigational products |
| CD19 t-haNK with Rituximab | EXPERIMENTAL | Participants will initially receive a single 3-week cycle of the CD19 thaNK as a single-agent regimen. Following a 1-week safety pause, participants will then receive a single 3-week cycle of CD19 t-haNK in combination with rituximab. Participants will then undergo the first tumor assessment. Participants with no evidence of progressive disease (PD) will be eligible to receive up to 2 additional 3-week cycles of CD19 t-haNK combination with rituximab. |
| Name | Type | Description |
|---|---|---|
| CD19 t-haNK- IV Administration | BIOLOGICAL | 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. |
| N-803 | DRUG | 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. |
| rituximab | DRUG | Rituximab is a genetically engineered chimeric murine/human monoclonal IgG1 kappa antibody directed against the CD20 antigen. Rituximab has an approximate molecular weight of 145 kD and has a binding affinity for the CD20 antigen of approximately 8.0 nM. |
| CD19 t-haNK | BIOLOGICAL | CD19t-haNK erived from the parental NK-92 (aNK) cell line, CD19 t-haNK is a human, allogeneic, NK cell line that has been engineered to express a CAR targeting CD19. Similar to the haNK cell line, CD19 t haNK has also been engineered to produce endoplasmic reticulum-retained IL 2 and the high-affinity (158V) variant of the Fcγ receptor (FcγRIIIa/CD16a), and thereby has enhanced CD16-targeted ADCC capabilities. CD19 t-haNK is similar to PD L1 t-haNK, differing only in the CAR that is expressed (CD19 vs PD-L1). Rituximab is a genetically engineered chimeric murine/human monoclonal IgG1 kappa antibody directed against the CD20 antigen. Rituximab has an approximate molecular weight of 145 kD and has a binding affinity for the CD20 antigen of approximately 8.0 nM. |
Inclusion Criteria: 1. Age ≥ 18 to ≤ 75 years old. 2. Able to understand and provide a signed informed consent that fulfils the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines. 3. Histologically or flow cytometry documented relapsed/refractory B-cell indol...
CD19 t-haNK is an investigational cell-based therapy being developed by ImmunityBio, Inc. for relapsed or refractory B-cell non-Hodgkin lymphoma. It is designed to target the CD19 protein found on B cells. The therapy is administered intravenously and is currently in clinical development, not yet approved for commercial use.
CD19 t-haNK is being studied for the treatment of relapsed or refractory B-cell non-Hodgkin lymphoma, including indolent non-Hodgkin lymphoma. The clinical program focuses on patients whose disease has returned or has not responded to prior therapies. It is an investigational therapy and has not been approved for any indication.
CD19 t-haNK targets CD19, a protein expressed on the surface of B cells. By binding to CD19, the therapy is intended to direct immune effector activity against malignant B cells in non-Hodgkin lymphoma. This targeted approach is being evaluated in early-phase clinical trials.
CD19 t-haNK is being developed by ImmunityBio, Inc., which trades on the Nasdaq under the ticker IBRX. The company is sponsoring the clinical trials evaluating this therapy in patients with relapsed or refractory B-cell non-Hodgkin lymphoma.
CD19 t-haNK is in Phase 1 clinical development. It is an investigational therapy and has not been approved by the FDA or any regulatory agency. The Phase 1 program is evaluating the therapy in patients with relapsed or refractory non-Hodgkin lymphoma.
CD19 t-haNK is being evaluated in clinical trials including NCT06334991, a Phase 1 study in relapsed or refractory non-Hodgkin lymphoma, and NCT07125872, a Phase 2 study in relapsed or refractory B-cell non-Hodgkin lymphoma. Another trial, NCT07477366, is a Phase 2 study combining CD19 t-haNK and NAI with rituximab in indolent non-Hodgkin lymphoma.
Yes, CD19 t-haNK is also known as CD19t-haNK, CD19t-haNK suspension, CD19 t-haNK- IV Administration, and CD19 t-haNK- Administration. These names refer to the same investigational therapy developed by ImmunityBio for relapsed or refractory B-cell non-Hodgkin lymphoma.