Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:52 AM
Study NCT ID:
NCT07477366
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-17
First Post:
2026-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of CD19 t-haNK and NAI With Rituximab in Participants With Indolent Non-Hodgkin Lymphoma
Sponsor:
ImmunityBio, Inc.
Organization:
Study Overview
Official Title:
Open-Label, Phase 2 Chemotherapy-Free Study of CD19 t-haNK and NAI in Combination With Rituximab in Participants With Relapsed/Refractory B-Cell Indolent Non-Hodgkin Lymphoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Open-Label, Phase 2 Chemotherapy-Free Study ofCD19 t-haNK and NAI in Combination With Rituximab in Participants With Relapsed/Refractory B-Cell Indolent Non-Hodgkin Lymphoma. 40 Participant will be screened for 20 subjects enrollment.
Detailed Description:
Participants will receive treatment for a maximum of 12 cycles( 36 weeks) or until they have PD, unacceptable toxicity, withdrawal consent, or if the investigator feels it is no longer their best interest to continue treatment.
Subjects first receive CD19t-haNK, N-803 and Rituximab for a 4-week induction cycle. If subjects respond to treatment they will receive maintenance therapy from cycle 2 to 12 (repeated 3 week cycles). All participants should be followed for collection of survival statis, disease status, and posttreatment therapies every 12 weeks (+/- 2 weeks). The follow up visits may occur in-person or via phone contact.
The cycles have visits on the following days: Cycle 1 (Day 1, 8, and 15), Cycles 2-6 (Day 1, 8) and Cycles 7-12 (Day 1). On each of these days, the following will be conducted: Concomitant Medication, Physical Exam, Vitals, ECOG and Labs.
Subjects first receive CD19t-haNK, N-803 and Rituximab for a 4-week induction cycle. If subjects respond to treatment they will receive maintenance therapy from cycle 2 to 12 (repeated 3 week cycles). All participants should be followed for collection of survival statis, disease status, and posttreatment therapies every 12 weeks (+/- 2 weeks). The follow up visits may occur in-person or via phone contact.
The cycles have visits on the following days: Cycle 1 (Day 1, 8, and 15), Cycles 2-6 (Day 1, 8) and Cycles 7-12 (Day 1). On each of these days, the following will be conducted: Concomitant Medication, Physical Exam, Vitals, ECOG and Labs.
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?: