CLINICAL TRIALS PROFILE FOR ANKTIVA

All Clinical Trials for ANKTIVA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT05618925 ↗	Study for Subjects With Relapsed/Refractory Non- Hodgkin Lymphoma	Not yet recruiting	ImmunityBio, Inc.	Phase 1	2022-11-15	Open-label, Phase 1 Study of CD19 t-haNK as a Single Agent and in Combination With an IL-15 Superagonist (N-803) and Rituximab in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma. Up to 20 subjects will be enrolled and randomized 1:1 to 1 of 2 cohorts, as outlined below. The initial 3 subjects will be sequentially enrolled in a staggered fashion, with a 7 day interval between each subject to enable the capture and monitoring of any acute and subacute toxicities.
NCT06061809 ↗	N-803 and PD-L1 t-haNK Combined With Bevacizumab for Recurrent or Progressive Glioblastoma	Not yet recruiting	ImmunityBio, Inc.	Phase 2	2024-06-03	This is a phase 2 open-label study to evaluate the safety and efficacy of N-803 and PD-L1 t-haNK when combined with Bevacizumab in subjects with recurrent or progressive GBM. Participants will receive N-803 subcutaneously (SC), PD-L1 t-haNK intravenously (IV), and Bevacizumab IV combination therapy. Treatment for all enrolled participants will consist of repeated cycles of 28 days for a maximum treatment period of 76 weeks (19 cycles). Treatment will be administered on days 1 and day 15 of each cycle. Treatment will be discontinued if the participant reports unacceptable toxicity (not corrected with dose reduction), withdraws consent, if the Investigator feels it is no longer in the participant's best interest to continue treatment, or the participant has confirmed progressive disease by iRANO, unless the participant is potentially deriving benefit per Investigator's assessment. Participants will be followed for collection of survival status every 12 weeks (± 2 weeks) for the first 2 years, then yearly thereafter.
NCT06239220 ↗	PD-L1 t-haNK, N-803 IL-15sa and Cetuximab for Recurrent, Metastatic HNSCC	RECRUITING	ImmunityBio, Inc.	PHASE2	2024-02-16	The purpose of this research study is to test the safety and efficacy of the combination of PD-L1 t-haNK (modified immune cells), N-803 (a manufactured protein that stimulates the immune system), and cetuximab (a targeted antibody) in treating advanced head and neck cancer. The names of the therapies involved in this study are: * PD-L1 t-haNK cell therapy (a NK cell therapy infusion) * N-803 (a type of recombinant human superagonist) * Cetuximab (a type of antibody)
NCT06239220 ↗	PD-L1 t-haNK, N-803 IL-15sa and Cetuximab for Recurrent, Metastatic HNSCC	RECRUITING	Glenn J. Hanna	PHASE2	2024-02-16	The purpose of this research study is to test the safety and efficacy of the combination of PD-L1 t-haNK (modified immune cells), N-803 (a manufactured protein that stimulates the immune system), and cetuximab (a targeted antibody) in treating advanced head and neck cancer. The names of the therapies involved in this study are: * PD-L1 t-haNK cell therapy (a NK cell therapy infusion) * N-803 (a type of recombinant human superagonist) * Cetuximab (a type of antibody)
NCT07108036 ↗	A Study to Assess Anktiva in Patients With Long Covid-19.	NOT_YET_RECRUITING	ImmunityBio, Inc.	PHASE2	2025-08-01	This study will test the safety and tolerability of Anktiva in patients with Long Covid. Eligible patients will receive up to 2 doses of Anktiva and have follow-up exams and tests.
NCT07123727 ↗	A Study to Examine Anktiva for the Treatment of COVID-19.	RECRUITING	ImmunityBio, Inc.	PHASE2	2025-09-01	This study will examine the safety and effectiveness of Anktiva in treating patients with Long COVID-19 which is defined as persistent symptoms of a COVID-19 infection that remain after the infection is over.

Clinical Trial Conditions for ANKTIVA

Condition Name

Condition Name for ANKTIVA
Intervention	Trials
Long COVID	2
Head and Neck Cancer	1
Head and Neck Squamous Cell Carcinoma	1
Long Covid 19	1

Condition MeSH

Condition MeSH for ANKTIVA
Intervention	Trials
Post-Acute COVID-19 Syndrome	2
Head and Neck Neoplasms	1
Glioblastoma	1
Lymphoma, Non-Hodgkin	1

Clinical Trial Locations for ANKTIVA

Trials by Country

Trials by Country for ANKTIVA
Location	Trials
United States	4

Trials by US State

Trials by US State for ANKTIVA
Location	Trials
California	3
Massachusetts	1

Clinical Trial Progress for ANKTIVA

Clinical Trial Phase

Clinical Trial Phase for ANKTIVA
Clinical Trial Phase	Trials
PHASE2	3
Phase 2	1
Phase 1	1

Clinical Trial Status

Clinical Trial Status for ANKTIVA
Clinical Trial Phase	Trials
RECRUITING	2
Not yet recruiting	2
NOT_YET_RECRUITING	1

Clinical Trial Sponsors for ANKTIVA

Sponsor Name

Sponsor Name for ANKTIVA
Sponsor	Trials
ImmunityBio, Inc.	5
Glenn J. Hanna	1

Sponsor Type

Sponsor Type for ANKTIVA
Sponsor	Trials
Industry	5
OTHER	1

Last updated: May 27, 2026

ANKTIVA clinical trials update and market projection: efficacy, pipeline status, and exclusivity timeline

ANKTIVA (rilzabrutinib) is a BTK inhibitor being developed for oncology indications; current public trial and FDA-market status data are not provided in the prompt. With no verified clinical trial identifiers, indication, sponsor, phase, enrollment status, or FDA regulatory milestones supplied, a complete, accurate clinical update and market projection cannot be produced.

What clinical trials are ongoing for ANKTIVA (rilzabrutinib)?

No trial identifiers, phases, enrollment numbers, endpoints, or sponsor/program details are included in the input. Without that, a factual clinical trials update would risk being incomplete or incorrect.

Which companies and sponsors are running ANKTIVA studies?

No sponsor information is provided.

What are ANKTIVA key endpoints and efficacy readouts?

No endpoint definitions, interim results, or readouts are provided.

What is the latest status of ANKTIVA phase 1, phase 2, and phase 3 trials?

No phase-by-phase status is included in the input, including trial registry references, last-updated dates, recruitment status, or completed/active labeling.

Has ANKTIVA reported interim or final results?

No results data are provided.

What safety signals have been reported for ANKTIVA?

No adverse event summaries or safety listings are provided.

When will ANKTIVA be filed with the FDA, and what is the expected approval timeline?

No NDA/BLA plans, trial completion dates, regulatory pathway assumptions (e.g., Breakthrough Therapy), or FDA communication history is included.

Does ANKTIVA have breakthrough, orphan, or fast-track designations?

No designation details are provided.

What FDA review pathway is most likely for ANKTIVA?

No indication and dossier timing inputs are provided.

What patents protect ANKTIVA, and when does exclusivity end?

The prompt contains no patent estate information, Orange Book listings, exclusivity grants, or territorial filing strategy.

What patent expiration dates drive ANKTIVA generic or biosimilar entry risk?

No patent expiration data are provided.

What method-of-use and formulation patents cover ANKTIVA?

No formulation or method-of-use patent details are provided.

What is the Orange Book status of ANKTIVA?

No Orange Book listing data is provided (drug name, application number, active ingredient, dosage form, reference product, patents in force, or exclusivity start dates).

Are there Paragraph IV challenges for ANKTIVA?

No ANDA filing, Paragraph IV notice, settlement agreements, or Hatch-Waxman litigation details are included.

Which generics are challenging ANKTIVA, and what is their litigation posture?

No challengers or docket outcomes are provided.

How strong is the patent estate for ANKTIVA versus competing BTK inhibitors?

No competitor set, formulation differences, or patent counts are provided.

How does ANKTIVA compare with ibrutinib, acalabrutinib, and zanubrutinib on IP and differentiation?

No comparative data is provided.

What generic entry risks exist for ANKTIVA, and what launch timing scenarios apply?

No expiration, exclusivity, or litigation schedule inputs are included, so entry timing cannot be computed.

What is the market size, uptake curve, and revenue projection for ANKTIVA?

No commercialization inputs are provided, including indication targets, addressable patient population, pricing assumptions, adoption curve, line-of-therapy placement, payer constraints, trial efficacy magnitude, or competitor share.

What pricing assumptions and penetration model would govern ANKTIVA revenue?

No pricing or market model inputs are provided.

What market segments drive ANKTIVA adoption by geography and payer mix?

No geography or reimbursement inputs are provided.

Key Takeaways

• A clinical trials update and market projection for ANKTIVA cannot be generated from the provided input because no verified trial, regulatory, patent, or commercialization data is included.
• Production of a factual, decision-grade analysis requires drug identity mapping to the correct active ingredient and program, plus trial registry milestones, FDA status, and IP/exclusivity dates.