Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07451054 | CD45BE-HSPC + CART-45 Cells | PHASE1 | NOT YET_RECRUITING | 42 | — | — | Jul 1, 2026 | Jul 1, 2051 | May 14, 2026 | 1 | United States |
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...