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Also known as CD19t-haNK suspension, CD19t-haNK
CD19 t-haNK · 1 trial · 1 indication
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 |
|---|---|---|
| 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 | 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 years old. 2. Able to understand and provide a signed informed consent that fulfills the relevant Human Research Ethics Committee (HREC) or Independent Ethics Committee (IEC) guidelines. 3. Histologically documented CD19- and CD20-positive B-cell NHL (excluding prima...
CD19 t-haNK is an investigational monoclonal antibody being studied for the treatment of relapsed or refractory Non-Hodgkin Lymphoma. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
CD19 t-haNK targets the CD19 protein, which is expressed on B cells and is commonly found in B-cell malignancies such as Non-Hodgkin Lymphoma. By targeting CD19, the therapy aims to direct the immune system against cancer cells.
CD19 t-haNK is being developed by ImmunityBio, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol IBRX. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational therapy.
CD19 t-haNK is currently in Phase 1 clinical development. It is an investigational drug being studied in an active clinical trial for relapsed or refractory Non-Hodgkin Lymphoma, and it has not yet received regulatory approval.
CD19 t-haNK is being evaluated in a Phase 1 clinical trial with the identifier NCT06334991. This study is enrolling approximately 20 participants with relapsed or refractory Non-Hodgkin Lymphoma and is being conducted in South Africa.
Yes, CD19 t-haNK is also known as CD19t-haNK suspension. These names refer to the same investigational therapy being developed by ImmunityBio for the treatment of relapsed or refractory Non-Hodgkin Lymphoma.