Study of Relapsed/ Refractory B-cell Non- Hodgkin Lymphoma

NCT07125872 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: ResQ215A-BCELL
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

Open Label, Phase 2 Study of CD19 t-haNK and N-803 in Combination with Rituximab in subjects with Relapsed/ Refractory B-cell Non- Hodgkin Lymphoma. 40 Participant will be screened for 20 subjects enrollment.

Conditions

Relapsed B-Cell Non Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

• Primary Endpoints( Efficacy)

  ORR in accordance with Lymphoma Response to Immunomodulatory Therapy Criteria(LYRIC). OS( Time from study treatment initiation to death)

  6 months

Secondary Outcomes (1)

• Secondary endpoints( Safety)

  2 years

Study Arms (1)

Open Label- Single Arm

OTHER

Study is open label: combination of SOC Chemo therapy and investigational products.

Biological: CD19 t-haNK- IV Administration

Interventions

CD19 t-haNK- IV Administration BIOLOGICAL

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. 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

Eligibility Criteria

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

You may qualify if:

• Age\>18 years old 2- Able to understand and provide a signed informed consent that fulfills the relevant Human Research Ethics Committee( HRECC) or independent Ethics Committee( IEC) guidelines 3. Histologically or flow cytometry documented B-cell NHL, (excluding primary central nervous system \[CNS\] lymphoma, chronic lymphocytic leukemia \[CLL\], and Burkitt lymphoma) 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 (Appendix 5) of 0 to 1.
• \. Stated willingness to comply with study procedures. 6. 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 must agree to use effective contraception while on study and for at least 30 days after the last dose of study drug. Nonsterile male participants must agree to use a condom while on study and for up to 30 days after the last dose of study drug. Effective contraception includes orals, injectables, surgical sterilization (e.g., vasectomy, tubal ligation), two forms of barrier methods (e.g., condom, diaphragm) and implants such as intrauterine devices (IUDs).

You may not qualify if:

• Participants with ANY of the following criteria are excluded from participation in the study:
• Histologically documented primary CNS lymphoma, CLL, Burkitt, Burkitt-like lymphoma.
• Known hypersensitivity or allergy to any component of the study medications, including sulfa-containing study medication(s) (e.g., 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 \[SGOT\])/ALT (SGPT) ≥ 2.5 × ULN.
• Alkaline phosphatase (ALP) levels ≥ 2.5 × ULN (or ≥ 5 × ULN in participants with bone metastases).
• Serum creatinine ≥ 160 µmol/L. 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.

Sponsors & Collaborators

• ImmunityBio, Inc.: lead

Study Sites (2)

Dr. Jackie Thomson Inc

Johannesburg, 2193, South Africa

RECRUITING

Albert Cellular Therapy

Pretoria, 0044, South Africa

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-Cell

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

Central Study Contacts

Atessa Kiani, MD

CONTACT

19499038749; atessa.kiani@immunitybio.com

Mark Nelson

CONTACT

mark.nelson@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: August 11, 2025
• First Posted: August 15, 2025
• Study Start: November 11, 2025
• Primary Completion (Estimated): May 25, 2027
• Study Completion (Estimated): May 25, 2028
• Last Updated: May 4, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (2)