Trial · NCT04093596
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of subjects experiencing Dose Limiting Toxicities at increasing doses of ALLO-715 | 28 Days | Dose limiting toxicities are defined as ALLO-715-related adverse events with onset within 28 days following infusion of ALLO-715. |
| Primary | To assess the overall safety profile and tolerability of ALLO-647 in combination with Fludarabine and/or cyclophosphamide or ALLO-647 alone, prior to ALLO-715 to confirm the dose of ALLO-647. | 33 days | The proportion of subjects in a dose cohort with DLTs of ALLO-647 |
| Primary | To assess the overall safety profile and tolerability of nirogacestat given concomitantly with ALLO-715 following lymphodepletion with Flu/ Cy/ ALLO-647. | 28 days | Dose limiting toxicities are defined as ALLO-715-related adverse events with onset within 28 days following infusion of ALLO-715. |
| Secondary | Cellular kinetics of ALLO-715 | up to 60 months | Levels of anti-BCMA CAR T cells in blood |
| Secondary | antitumor activity of ALLO-715 in combination with nirogacestat | up to 60 months | overall -response rate (ORR) |
| Secondary | Cellular kinetics of ALLO-715 in combination with nirogacestat | up to 60 months | Levels of anti-BCMA CAR T cells in blood |
| Secondary | Pharmacokinetics of ALLO-647 | up to 60 months | Serum concentration levels of ALLO-647 |
| Secondary | Pharmacokinetics of nirogacestat | up to 60 months | Serum concentration levels of nirogacestat |
| Secondary | Incidence of immunogenicity against ALLO-715 and ALLO-647 | up to 60 months | detection and levels of anti-drug antibodies |
| Secondary | Immune monitoring after lymphodepletion regimen | up to 60 months | Detection of the following circulating cells: T cell subset, B lymphocytes, and NK cells |
| Secondary | Anti-tumor activity of ALLO-715 | up to 60 months | overall response rate |
| Secondary | Anti-tumor activity of ALLO-715 | up to 60 months | duration of response |
| Secondary | Anti-tumor activity of ALLO-715 | up to 60 months | overall survival |
| Secondary | Anti-tumor activity of ALLO-715 | up to 60 months | minimal residual disease |
| Secondary | To evaluate the expression of BCMA in bone marrow plasma cells with and without nirogacestat | up to 60 months | Overall response rate of ALLO-715 with and without Nirogacestat |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT04093596/registered