Spots Global Cancer Trial Database for A Phase 1 Study of ADI-001 in B Cell Malignancies

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Trial Identification

Brief Title: A Phase 1 Study of ADI-001 in B Cell Malignancies

Official Title: A Phase 1 Safety and Efficacy Study of ADI-001 Anti-CD20 CAR-engineered Allogeneic Gamma Delta (γδ) T Cells in Adults With B Cell Malignancies

Study ID: NCT04735471

Conditions

Lymphoma, Follicular

Lymphoma, Mantle-Cell

Marginal Zone Lymphoma

Primary Mediastinal B-cell Lymphoma

Diffuse Large B Cell Lymphoma

Lymphoma, Non-Hodgkin

Interventions

ADI-001

Fludarabine

Cyclophosphamide

Study Description

Brief Summary: This is a Phase 1 dose escalation study following a 3+3 study design. The purpose of this study is to evaluate the safety and efficacy of ADI-001 in patients with B cell malignancies.

Detailed 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 and tolerability of ADI-001 and is designed to determine the maximum tolerated dose (MTD) or maximum assessed dose (MAD). Patients will be administered a single infusion or multiple infusions of ADI-001 cells. The study will include the following two parts: Part 1 : dose escalation and extension. Parts 1a (escalation) and 1b (extension) will involve escalation and administration of single dose of ADI-001 and multiple doses of ADI-001. Part 2 : dose expansion will involve dose administration of ADI-001 at MTD/MAD as determined in Part 1. The study will also assess the pharmacokinetics and pharmacodynamics of ADI-001.