NCT04735471

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

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Adicet Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lymphoma, Follicular
• Lymphoma, Mantle-Cell
• Marginal Zone Lymphoma
• Primary Mediastinal B-cell Lymphoma
• Diffuse Large B Cell Lymphoma
• Lymphoma, Non-Hodgkin

Interventions

Type	Name	Description
GENETIC	ADI-001	Anti-CD20 CAR-T
DRUG	Fludarabine	Chemotherapy for Lymphodepletion
DRUG	Cyclophosphamide	Chemotherapy for Lymphodepletion

Timeline

• Start date: 2021-03-04
• Primary completion: 2025-02-03
• Completion: 2025-02-03
• First posted: 2021-02-03
• Last updated: 2025-06-18

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study