Ignite Creation Date:
2025-12-24 @ 11:46 AM
Ignite Modification Date:
2026-01-04 @ 11:58 AM
Study NCT ID:
NCT04052061
Status:
WITHDRAWN
Last Update Posted:
2025-02-21
First Post:
2019-08-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
QUILT-3.061: CD19 t-haNK in Subjects With Diffuse Large B-Cell Lymphoma
Sponsor:
ImmunityBio, Inc.
Organization:
Study Overview
Official Title:
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WITHDRAWN
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Trial not initiated
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: