A Study of ADI-001 in B Cell Malignancies
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Diffuse Large B Cell Lymphoma
- Lymphoma, Burkitt
- Lymphoma, Follicular
- Lymphoma, Large B-Cell, Diffuse
- Lymphoma, Mantle Cell
- Lymphoma Non-Hodgkin
- Marginal Zone Lymphoma
- Mediastinal Lymphoma
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: 3+3 Factorial DesignMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
ADI-001 is an investigational immunotherapy composed of allogeneic gamma delta T cells that is being evaluated as a potential treatment for patients diagnosed with B cell malignancies who have relapsed or are refractory to at least two prior regimens. This first-in-human study will assess the safety...
ADI-001 is an investigational immunotherapy composed of allogeneic gamma delta T cells that is being evaluated as a potential treatment for patients diagnosed with B cell malignancies who have relapsed or are refractory to at least two prior regimens. This first-in-human study will assess the safety and tolerability of ADI-001 and is designed to determine the maximum tolerated dose (MTD) or optimal dose. Patients will be administered a single infusion of ADI-001 cells. A combination of ADI-001 and interleukin (IL)-2 may also be evaluated after the MTD or optimal dose has been determined for the single agent. The study will also assess the pharmacokinetics and pharmacodynamics of ADI-001.
Tracking Information
- NCT #
- NCT04735471
- Collaborators
- Not Provided
- Investigators
- Study Director: Rose Lai, MD Adicet Bio