Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CART-45 cells · 1 trial · 4 indications
Type, frequency and severity of adverse events as assessed by CTCAE V6.0. Each disease-specific cohort will be analyzed separately.
Unacceptable toxicity as defined by the protocol. DLTs will be evaluated separately by each disease-specific cohort.
Selected based on an isotonic regression model. The MTD will be established separately by disease-specific cohort
Evaluated by Cohort/dose level using a multi-criteria decision analysis.
| Arm | Type | Description |
|---|---|---|
| Cohort A: B-cell Non-Hodgkin Lymphoma (B-cell NHL), Richter's Transformation (RT) | EXPERIMENTAL | - |
| Cohort B: T-cell Non-Hodgkin Lymphoma (T-cell NHL), Hodgkin Lymphoma (HL) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| CART-45 cells | BIOLOGICAL | Autologous base edited anti-CD45 CAR T cells |
| CD45BE-HSPC | BIOLOGICAL | CD45 base edited hematopoietic stem and progenitor cells |
Inclusion Criteria: 1\. Signed informed consent form 2. Male or females age ≥ 18 years 3. Disease-Specific Criteria a. B-cell Non-Hodgkin Lymphoma (B-cell NHL)- including the following sub-types: i. Patients with any of the following large B-cell lymphoma diagnoses who meet the prior treatment cr...
CART-45 cells is an investigational cell therapy being developed for B-Cell Non-Hodgkin Lymphoma (NHL). It is currently in Phase 1 clinical development and is not yet approved by the FDA. The therapy is being studied in patients with B-Cell NHL, as well as other related conditions.
CART-45 cells is being developed by Gilead Sciences, Inc. (NASDAQ: GILD). The company is conducting a Phase 1 clinical trial to evaluate the safety and efficacy of this investigational therapy in patients with B-Cell Non-Hodgkin Lymphoma.
CART-45 cells is in Phase 1 clinical development. It is an investigational therapy and has not received FDA approval. The ongoing Phase 1 trial is designed to assess the safety and preliminary efficacy of CART-45 cells in patients with B-Cell Non-Hodgkin Lymphoma.
CART-45 cells is being studied in a Phase 1 clinical trial with the identifier NCT07451054. This trial, titled 'CD45BE-HSPC + CART-45 Cells', is not yet recruiting and has an estimated enrollment of 42 participants. The study is being conducted in the United States and includes patients with B-Cell Non-Hodgkin Lymphoma and other related conditions.
CART-45 cells is not the same as CD45BE-HSPC. The clinical trial NCT07451054 is studying a combination of CD45BE-HSPC and CART-45 cells. CD45BE-HSPC refers to hematopoietic stem and progenitor cells that have been modified, while CART-45 cells are a separate investigational cell therapy product.