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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05020015 | A Study of TAK-007 in Adults With Relapsed or Refractory (r/r) B-cell Non-Hodgkin Lymphoma (NHL) | PHASE2 | ACTIVE NOT_RECRUITING | 27 | — | — | Nov 12, 2021 | Dec 20, 2038 | Mar 31, 2026 | 15 | United States |
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with a study intervention or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the study intervention or medicinal product.
Laboratory parameters included hematology, clinical chemistry, serum immunoglobulin and urinalysis tests.
Vital signs included body temperature (oral or tympanic measurement), sitting blood pressure (after the participant had rested for at least 5 minutes), and pulse rate (beats per minute \[bpm\]).
| Arm | Type | Description |
|---|---|---|
| Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells | EXPERIMENTAL | Participants received lymphodepleting chemotherapy per day intravenously (IV) for 3 days followed by TAK-007 200×10\^6 anti-CD19 chimeric antigen receptor (CD19-CAR+) viable NK cells, single-dose, IV infusion, once on Day 0. |
| Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | EXPERIMENTAL | Participants received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 - 800×10\^6 CD19-CAR+ viable NK cells, single-dose, IV infusion, once on Day 0. |
| Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | EXPERIMENTAL | Participants with r/r LBCL received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 at the dose level selected based on the dose escalation part (800×10\^6 CD19-CAR+ viable NK cells), as a single-dose, IV infusion, once on Day 0 to determine recommended phase 2 dose (RP2D). |
| Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells | EXPERIMENTAL | Participants with r/r iNHL received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 at the dose level(s) selected based on the dose escalation part (800×10\^6 CD19-CAR+ viable NK cells), as a single-dose, IV infusion, once on Day 0 to determine RP2D. |
| Name | Type | Description |
|---|---|---|
| TAK-007 | BIOLOGICAL | TAK-007 intravenous injection. |
| Chemotherapy Agents | DRUG | Fludarabine and cyclophosphamide as per standard of care. |
Inclusion Criteria: 1. Participants who have a life expectancy ≥12 weeks. 2. Participants who have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 3. Participants with a diagnosis of previously treated r/r histologically proven Cluster of Differentiation (CD)19 expressing ...