Relapsed B-Cell Non-Hodgkin LymphomaPhase 2NCT07477366
Study of CD19 t-haNK and NAI With Rituximab in Participants With Indolent Non-Hodgkin Lymphoma
A Phase 2 study testing CD19 t-haNK- IV Administration, N-803 and rituximab in people with Relapsed B-Cell Non-Hodgkin Lymphoma, run by ImmunityBio, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Relapsed B-Cell Non-Hodgkin Lymphoma
- What is being tested?
- CD19 t-haNK- IV Administration, N-803 and rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 to ≤ 75 years old.
- Able to understand and provide a signed informed consent that fulfils the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.
- Histologically or flow cytometry documented relapsed/refractory B-cell indolent NHL (iNHL) including but not limited to follicular lymphoma [FL]; lymphoplasmacytic lymphoma [LPL], also known as Waldenstrom macroglobulinemia [WM]; marginal zone lymphoma [MZL] with the following specific criteria:
- Have completed ≥ 2 lines of cytotoxic chemotherapy.
- Have received rituximab or another anti-CD20 antibody.
- Have measurable disease by Lugano classification documented within 8 weeks of the time of consent, defined as nodal lesions > 15 mm in the long axis or extranodal lesions > 10 mm in long and short axis, or bone marrow involvement that is biopsy proven.
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- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Stated willingness to comply with study procedures.
- Able to attend required study visits and return for adequate follow-up, as required by this protocol.
- Agreement to practice effective contraception for female participants of childbearing potential and nonsterile males. Female participants of childbearing potential are defined as any female who has experienced menarche and who is NOT permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause. Female participants of childbearing potential must have a negative pregnancy test and adhere to using a highly effective method of contraception (eg, tubal ligation, approved hormonal contraceptive, or an intrauterine device [IUD]) prior to screening and agree to continue its use during the study or be surgically sterilized (eg, hysterectomy) while on study and for 12 months post last dose of study drug. Male participants must agree to use barrier methods of birth control while on study and for 12 months post last dose of study drug).
Who cannot join
- Histologically documented large B-cell lymphomas (eg, diffuse large B-cell lymphoma [DLBCL], anaplastic large cell lymphoma [ALCL], follicular large cell lymphoma, mantle cell lymphoma), primary central nervous system (CNS) lymphoma, chronic lymphocytic leukemia (CLL), Burkitt and Burkitt-like lymphoma.
- Known hypersensitivity or allergy to any component of the study medications, including sulfa containing study medication(s) (eg, albumin [human], dimethyl sulfoxide [DMSO]).
- Inadequate organ function, evidenced by the following laboratory results:
- ANC < 1000 cells/mm3.
- Platelet count < 100,000 cells/mm3.
- Total bilirubin ≥ 1.5 × the upper limit of normal (ULN; unless the participant has documented Gilbert's syndrome or indirect hyperbilirubinemia).
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- Aspartate aminotransferase (AST /ALT ≥ 2.5 × ULN.
- Alkaline phosphatase (ALP) levels ≥ 2.5 × ULN (or ≥ 5 × ULN in participants with bone metastases).
- Serum creatinine ≥ 2 mg/dL. NOTE: Each study site should use its institutional ULN to determine eligibility
- Serious uncontrolled concomitant disease that would contraindicate the use of the investigational drug used in this study or that would put the participant at high risk for treatment-related complications.
- History of significant autoimmune disease OR active, uncontrolled autoimmune phenomenon: such as systemic lupus erythematous, Wegner's glomerulonephritis, autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura requiring steroid therapy defined as > 20 mg of prednisone or equivalent daily.
- History of allogeneic hematopoietic stem cell transplantation (HSCT) requiring ongoing systemic graft versus host disease (GvHD) therapy.
- Anti-CD20 antibody treatment less than 2 weeks prior to cell infusion.
- History of receiving allograft organ transplant requiring immunosuppression.
- Participants that underwent a solid organ transplant who develop high grade lymphomas or leukemias.
- Metastases to the CNS, including the parenchyma or leptomeninges.
- Nonmalignant CNS disease (eg, stroke, epilepsy, vasculitis, or neurodegenerative disease).
- History of or active inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).
- Uncontrolled hypertension (systolic > 160 mm Hg and/or diastolic > 110 mm Hg) or clinically significant (ie, active) cardiovascular disease, cerebrovascular accident/stroke, or myocardial infarction within 6 months prior to first study medication; unstable angina; congestive heart failure of New York Heart Association Class 2 or higher; or serious cardiac arrhythmia requiring medication.
- Current chronic daily treatment (continuous for > 3 months) with systemic corticosteroids as defined as > 20 mg of prednisone or equivalent daily, excluding inhaled steroids. Short-term steroid use to prevent IV contrast allergic reaction or anaphylaxis in participants who have known contrast allergies is allowed.
- Currently taking any medication(s) (herbal or prescribed) known to have an adverse drug reaction with any of the study medications.
- History of human immunodeficiency virus (HIV) with current CD4+ T-cell count < 350 cells/μL and/or a detectable HIV viral load.
- Known carriers of hepatitis B virus (HBV) infection that is currently hepatitis B surface antigen (HBsAg) positive.
- Concurrent active malignancy other than basal or squamous cell carcinomas of the skin.
- Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
- Women who are pregnant or breastfeeding.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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.
- Conditions
- Relapsed B-Cell Non-Hodgkin Lymphoma
- Being tested
- CD19 t-haNK- IV Administration, N-803, rituximab
- Medical subject headings
- Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD19 t-haNK- IV AdministrationBiological
CD19-Directed Therapies: CD19-targeted therapies, are biologic agents specifically designed to recognize and eliminate CD19-expressing B-cell malignancies. These therapies differ from traditional chemotherapy or small molecule inhibitors by leveraging the patient's immune system to achieve targeted cytotoxicity. Their mechanism of action involves direct binding to the CD19 antigen on malignant B cells, leading to immune-mediated cell death.
N-803Drug
N-803 Subcutaneous (SQ): N-803 is a novel IL-15 superagonist immunotherapy administered subcutaneously. It is designed to enhance the proliferation and activation of natural killer (NK) cells and CD8+ T cells without stimulating regulatory T cells. N-803 SQ differs from other cytokine therapies due to its improved pharmacokinetic profile, enhanced in vivo activity, and reduced toxicity.
rituximabDrug
Also called Rituxan
Rituximab is a genetically engineered chimeric murine/human monoclonal IgG1 kappa antibody directed against the CD20 antigen. Rituximab has an approximate molecular weight of 145 kD and has a binding affinity for the CD20 antigen of approximately 8.0 nM.
| Study group | Role | What they receive |
|---|---|---|
| Open Label- Single Arm | Other | Open label: combination of Rituximab and investigational products Receives: Biological: CD19 t-haNK- IV Administration; Drug: N-803; Drug: rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR in accordance with Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC)
Measured: Up to 9 months
OS (time from study treatment initiation to death)
Measured: Up to 89 weeks
Secondary outcomes (9)
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) graded using the National Cancer Institute (NCI) CTCAE Version 6.0
Measured: Up to 37 weeks
Clinically important changes in laboratory tests - Hematology
Laboratory tests include hematology and will be assessed/measured per the site-specific normal lab ranges
Measured: Up to 37 weeks
Clinically important changes in laboratory tests - Chemistry
Laboratory tests include chemistry and will be assessed/measured per the site-specific normal lab ranges
Measured: Up to 37 weeks
Clinically important changes in laboratory tests - Urinalysis
Laboratory tests include urinalysis and will be assessed/measured per the site-specific normal lab ranges
Measured: By end of screening
Clinically important changes in laboratory tests - Pregnancy Test
Laboratory tests include pregnancy test and will be assessed/measured per the site-specific normal lab ranges
Measured: Up to 37 weeks
Clinically important changes in vital signs - heart rate
Vital signs include heart rate measured by how many heart beats per minute
Measured: Up to 37 weeks
Clinically important changes in vital signs - blood pressure
Vital signs include blood pressure reported as systolic/diastolic - measured in mm Hg
Measured: Up to 37 weeks
Clinically important changes in vital signs - respiratory rate
Vital signs include respiratory rate measured in how many breaths per minute
Measured: Up to 37 weeks
Clinically important changes in vital signs - Oxygen saturation
Vital signs include oxygen saturation measured by percentage of hemoglobin saturated with oxygen in the blood
Measured: Up to 37 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed B-Cell Non-Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by ImmunityBio, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ImmunityBio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07477366
- Sponsor's protocol ID
- ResQ215B-BCELL
- Status last verified
- Feb 2026
- First submitted
- 11 Mar 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07477366
- Acronym / sponsor ID
- ResQ215B-BCELL
- Conditions
- Relapsed B-Cell Non-Hodgkin Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- ImmunityBio, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Label- Single Arm | Other | Biological: CD19 t-haNK- IV Administration, Drug: N-803, Drug: rituximabOpen label: combination of Rituximab and investigational products |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 to ≤ 75 years old.
- Able to understand and provide a signed informed consent that fulfils the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.
- Histologically or flow cytometry documented relapsed/refractory B-cell indolent NHL (iNHL) including but not limited to follicular lymphoma [FL]; lymphoplasmacytic lymphoma [LPL], also known as Waldenstrom macroglobulinemia [WM]; marginal zone lymphoma [MZL] with the following specific criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Stated willingness to comply with study procedures.
Key exclusion criteria (26 listed)
- Histologically documented large B-cell lymphomas (eg, diffuse large B-cell lymphoma [DLBCL], anaplastic large cell lymphoma [ALCL], follicular large cell lymphoma, mantle cell lymphoma), primary central nervous system (CNS) lymphoma, chronic lymphocytic leukemia (CLL), Burkitt and Burkitt-like lymphoma.
- Known hypersensitivity or allergy to any component of the study medications, including sulfa containing study medication(s) (eg, albumin [human], dimethyl sulfoxide [DMSO]).
- Inadequate organ function, evidenced by the following laboratory results:
- Serious uncontrolled concomitant disease that would contraindicate the use of the investigational drug used in this study or that would put the participant at high risk for treatment-related complications.
- History of significant autoimmune disease OR active, uncontrolled autoimmune phenomenon: such as systemic lupus erythematous, Wegner's glomerulonephritis, autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura requiring steroid therapy defined as > 20 mg of prednisone or equivalent daily.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CD19 t-haNK- IV AdministrationCD19-Directed Therapies: CD19-targeted therapies, are biologic agents specifically designed to recognize and eliminate CD19-expressing B-cell malignancies. These therapies differ from traditional chemotherapy or small molecule inhibitors by leveraging the patient's immune system to achieve targeted cytotoxicity. Their mechanism of action involves direct binding to the CD19 antigen on malignant B cells, leading to immune-mediated cell death. | Biological | Open Label- Single Arm |
| N-803N-803 Subcutaneous (SQ): N-803 is a novel IL-15 superagonist immunotherapy administered subcutaneously. It is designed to enhance the proliferation and activation of natural killer (NK) cells and CD8+ T cells without stimulating regulatory T cells. N-803 SQ differs from other cytokine therapies due to its improved pharmacokinetic profile, enhanced in vivo activity, and reduced toxicity. | Drug | Open Label- Single Arm |
| rituximabAlso: RituxanRituximab is a genetically engineered chimeric murine/human monoclonal IgG1 kappa antibody directed against the CD20 antigen. Rituximab has an approximate molecular weight of 145 kD and has a binding affinity for the CD20 antigen of approximately 8.0 nM. | Drug | Open Label- Single Arm |
Primary outcome
ORR in accordance with Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC)
Time frame: Up to 9 months
OS (time from study treatment initiation to death)
Time frame: Up to 89 weeks
9 secondary outcomes
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) graded using the National Cancer Institute (NCI) CTCAE Version 6.0
Time frame: Up to 37 weeks
Clinically important changes in laboratory tests - Hematology
Time frame: Up to 37 weeks
Clinically important changes in laboratory tests - Chemistry
Time frame: Up to 37 weeks
Clinically important changes in laboratory tests - Urinalysis
Time frame: By end of screening
Clinically important changes in laboratory tests - Pregnancy Test
Time frame: Up to 37 weeks
Clinically important changes in vital signs - heart rate
Time frame: Up to 37 weeks
Clinically important changes in vital signs - blood pressure
Time frame: Up to 37 weeks
Clinically important changes in vital signs - respiratory rate
Time frame: Up to 37 weeks
Clinically important changes in vital signs - Oxygen saturation
Time frame: Up to 37 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CD19 t-haNK- IV Administration, N-803 and rituximab in people with Relapsed B-Cell Non-Hodgkin Lymphoma, run by ImmunityBio, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrew Mullins (323-240-2645, andrew.mullins@immunitybio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR in accordance with Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) (time frame: Up to 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.