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Adjusted LOA
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QEL-005 · 1 trial · 4 indications
Assessment of safety and tolerability of QEL-005 during the Dose Escalation Phase, as measured by the incidence of protocol-defined dose limiting toxicities (DLTs).
Assessment of safety and tolerability of D2TRA \& SSc through the collection and evaluation of the incidence and severity grades of all TEAEs, AEs, and AESIs using the Common Terminology Criteria for Adverse Events (CTCAE)
Evaluation of safety through the assessment of clinically significant abnormalities in safety laboratory parameters, ECG findings, and vital signs.
| Arm | Type | Description |
|---|---|---|
| Dose Escalation | EXPERIMENTAL | Dose escalation will involve 3 distinct dose level ranges. Each dose level will enrol at least 3 participants |
| Dose Expansion | EXPERIMENTAL | The dose selected for dose expansion will be based on safety and any relevant additional data emerging from the Dose Escalation phase |
| Name | Type | Description |
|---|---|---|
| QEL-005 | DRUG | QEL-005 is an autologous cell therapy that is composed of engineered regulatory T cells transduced with a lentiviral vector containing a CAR directed against the B cell marker CD19. Treatment will be given via an IV infusion. |
Inclusion Criteria: * Participants must be at least 18 years of age at the time of signing the informed consent. * Up to date vaccination status and no planned vaccinations for post 3 months infusion * Adequate haematological, liver and renal function * Willing to undergo annual influenza vaccinati...