NCT04052061

QUILT-3.061: CD19 t-haNK in Subjects With Diffuse Large B-Cell Lymphoma

Open-Label, Phase 1 Study of CD19 t-haNK In Subjects With Diffuse Large B-Cell Lymphoma Who Have Received 2 Or More Lines of Therapy And Are Ineligible For Transplant

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: ImmunityBio, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase 1 study to assess the safety, preliminary efficacy of CD19 t-haNK and to determine the maximal tolerated dose and designate the recommended phase 2 dose in subjects with diffuse large B-cell lymphoma (DLBCL).

Detailed description

Phase 1 study to assess the safety, preliminary efficacy of CD19 t-haNK and to determine the maximal tolerated dose and designate the recommended phase 2 dose in subjects with diffuse large B-cell lymphoma (DLBCL). The study will be conducted in 2 parts: part 1 will involve dose escalation and part 2 will involve expansion of the recommended phase 2 dose.

Conditions

• Diffuse Large B Cell Lymphoma
• Large-cell Lymphoma
• Lymphoma, B-Cell
• Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	CD19 t-haNK	CD19 t-haNK Suspension for Infusion

Timeline

• Start date: 2019-09-16
• Primary completion: 2021-09-18
• Completion: 2022-08-19
• First posted: 2019-08-09
• Last updated: 2025-02-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study