Study of CD19 t-haNK and NAI With Rituximab in Participants With Indolent Non-Hodgkin Lymphoma

NCT07477366 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: ResQ215B-BCELL
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Relapsed B-Cell Non-Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (2)

• ORR in accordance with Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC)

  Up to 9 months

• OS (time from study treatment initiation to death)

  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

  Up to 37 weeks

• Clinically important changes in laboratory tests - Hematology

  Up to 37 weeks

• Clinically important changes in laboratory tests - Chemistry

  Up to 37 weeks

• Clinically important changes in laboratory tests - Urinalysis

  By end of screening

• Clinically important changes in laboratory tests - Pregnancy Test

  Up to 37 weeks

Study Arms (1)

Open Label- Single Arm

OTHER

Open label: combination of Rituximab and investigational products

Biological: CD19 t-haNK- IV Administration; Drug: N-803; Drug: rituximab

Interventions

CD19 t-haNK- IV Administration BIOLOGICAL

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.

Open Label- Single Arm

N-803 DRUG

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.

Open Label- Single Arm

rituximab DRUG

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.

Also known as: Rituxan

Open Label- Single Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• ImmunityBio, Inc.: lead

MeSH Terms

Conditions

Lymphoma, B-Cell

Interventions

ALT-803; Rituximab

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Andrew Mullins

CONTACT

323-240-2645; andrew.mullins@immunitybio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 17, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share