Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07477366
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.
Study:
NCT07477366
Study Brief:
Protocol Section:
NCT07477366