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Active, not recruitingNCT06334991Updated Jul 10, 2026

Study for Participants With Relapsed/Refractory Non-Hodgkin Lymphoma

A Phase 1 interventional study of CD19 t-haNK in Non-Hodgkin Lymphoma Refractory/ Relapsed, sponsored by ImmunityBio, Inc.. Active, not recruiting at 3 sites in South Africa. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-10.

Sponsored by ImmunityBio, Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

Open Label, Phase 1 study of CD19 t-haNK as a single agent and combination with rituximab in subjects with selected CD19+ and CD20+ R/R B-cell non-Hodgkin Lymphoma( NHL).

Read the detailed description

This is a Phase 1, first-in-human (FIH), open-label study to evaluate the safety of CD19 t-haNK as a single agent and the safety and preliminary efficacy of CD19 t-haNK in combination with rituximab in participants with selected CD19+ and CD20+ R/R B-cell non-Hodgkin lymphoma (NHL). Up to 20 participants will receive at least 1 dose of study drug. The initial 3 participants will receive study drug in a staggered fashion, with a 7-day interval between each participant to evaluate the safety profile of the investigational product. Participants will initially receive a single 3-week cycle of the CD19 t-haNK as a single-agent regimen. Following a 1-week safety pause, participants will then receive a 3-week cycle of CD19 t-haNK in combination with rituximab. Participants will then undergo the first tumor assessment. Participants with no evidence of progressive disease (PD) will be eligible to receive up to 2 additional 3-week cycles of CD19 t-haNK in combination with rituximab

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Conditions studied

  • Non-Hodgkin Lymphoma Refractory/ Relapsed
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In context

Lead sponsor

ImmunityBio, Inc. is the lead sponsor of 82 studies on the registry; 15 are open to participants now.

Of its 23 completed or terminated interventional studies of FDA-regulated products, 17 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age ≥ 18 years old.
  2. Able to understand and provide a signed informed consent that fulfills the relevant Human Research Ethics Committee (HREC) or Independent Ethics Committee (IEC) guidelines.
  3. Histologically documented CD19- and CD20-positive B-cell NHL (excluding primary CNS lymphoma, CLL, and Burkitt lymphoma) with the following specific criteria:

    1. Have completed ≥ 2 lines of cytotoxic chemotherapy.
    2. Have received rituximab or another anti-CD20 antibody.
    3. 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.
    4. Have CD19- and CD20-positive disease confirmed on the diagnostic or repeat biopsy specimen. A minimum of 5% CD19 and CD20 positivity by immunohistochemistry or flow cytometry is required.
  4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
  5. Expected survival > 16 weeks.
  6. Stated willingness to comply with study procedures.
  7. Able to attend required study visits and return for adequate followup, as required by this protocol.
  8. 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 5 months after the last dose of study drug. Nonsterile male participants must agree to use a condom while on study and for up to 5 months after the last dose of study drug. Effective contraception includes surgical sterilization (eg, vasectomy, tubal ligation), two forms of barrier methods (eg, condom, diaphragm), and intrauterine devices (IUDs).

Exclusion criteria

Exclusion Criteria:

  1. Histologically documented primary CNS lymphoma, CLL, Burkitt, or Burkitt-like lymphoma.
  2. Known hypersensitivity to sulfa-containing study medication(s), including anaphylactic reaction to sulfa-containing medications.
  3. Known allergy to albumin (human) or dimethyl sulfoxide (DMSO).
  4. 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.
  5. 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.
  6. History of allogeneic hematopoietic stem-cell transplantation (HSCT) requiring ongoing systemic graft versus host disease (GvHD) therapy.
  7. Anti-CD20 antibody treatment less than 2 weeks prior to cell infusion.
  8. History of receiving allograft organ transplant requiring immunosuppression.
  9. Participants post solid organ transplant who develop high grade lymphomas or leukemias.
  10. CD19- and CD20-positive metastases to the CNS, including the parenchyma
  11. Nonmalignant CNS disease (eg, stroke, epilepsy, vasculitis, or neurodegenerative disease).
  12. History of or active inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).
  13. Inadequate organ function, evidenced by the following laboratory results:

    1. ANC \< 1000 cells/mm3.
    2. Platelet count \< 100,000 cells/mm3.
    3. Total bilirubin ≥ 1.5 × the upper limit of normal (ULN; unless the participant has documented Gilbert's syndrome or indirect hyperbilirubinemia).
    4. Aspartate aminotransferase (AST [SGOT]/ALT (SGPT) ≥ 2.5 × ULN.
    5. Alkaline phosphatase (ALP) levels ≥ 2.5 × ULN (or ≥ 5 × ULN in participants with bone metastases).
    6. Serum creatinine > 1.6 mg/dL.
    7. Each study site should use its institutional ULN to determine eligibility.
  14. 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 grade 2 or higher; or serious cardiac arrhythmia requiring medication.
  15. Current chronic daily treatment (continuous for > 3 months) with systemic corticosteroids 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.
  16. Currently taking any medication(s) (herbal or prescribed) known to have an adverse drug reaction with any of the study medications.
  17. Tested positive for tuberculosis (TB) utilizing the QuantiFERON Gold TB test.
  18. History of human immunodeficiency virus (HIV) with current CD4+ T-cell count \< 350 cells/μL and a detectable HIV viral load.
  19. Known carriers of hepatitis B virus (HBV) infection that is currently hepatitis B surface antigen (HBsAg) positive.
  20. Concurrent active malignancy other than basal or squamous cell carcinomas of the skin.
  21. Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
  22. Women who are pregnant or breastfeeding
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    CD19 t-haNK with Rituximab

    Participants will initially receive a single 3-week cycle of the CD19 thaNK as a single-agent regimen. Following a 1-week safety pause, participants will then receive a single 3-week cycle of CD19 t-haNK in combination with rituximab. Participants will then undergo the first tumor assessment. Participants with no evidence of progressive disease (PD) will be eligible to receive up to 2 additional 3-week cycles of CD19 t-haNK combination with rituximab.

    Biological: CD19 t-haNK

Interventions

  • BiologicalCD19 t-haNK

    CD19t-haNK erived from the parental NK-92 (aNK) cell line, CD19 t-haNK is a human, allogeneic, NK cell line that has been engineered to express a CAR targeting CD19. Similar to the haNK cell line, CD19 t haNK has also been engineered to produce endoplasmic reticulum-retained IL 2 and the high-affinity (158V) variant of the Fcγ receptor (FcγRIIIa/CD16a), and thereby has enhanced CD16-targeted ADCC capabilities. CD19 t-haNK is similar to PD L1 t-haNK, differing only in the CAR that is expressed (CD19 vs PD-L1). 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: Rituximab

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What researchers measure

Primary outcomes

  1. Overall safety evaluation in combining CD19 t haNK as a single agent with rituximab

    Safety will be assessed for all participants and will include vital signs, physical examinations, clinical labs (hematology, chemistry panel, pregnancy tests), cytokine levels, electrocardiograms, neurological assessments, and the incidence and severity of adverse events (AEs) graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. All participants will receive follow-up phone calls 6 hours (± 1 hour) and 24 hours (± 2 hours) post infusion for AE collection during Cycle 1

    Time frame: 30 days

  2. Incidence of treatment-emergent AEs (TEAEs) and serious AEs (SAEs) graded using the National Cancer Institute (NCI) CTCAE Version 5.0.Clinically important changes in safety laboratory tests and vital signs.

    The incidence of TEAEs and SAEs will be presented by System Organ Class and Medical Dictionary for Regulatory Activities (MedDRA) preferred term. All AEs will be graded using CTCAE Version 5.0 except for CRS and ICANS, which will be graded using ICE score. The incidence of clinically important changes in safety laboratory tests and vital signs will also be presented.

    Time frame: 12 months

Secondary outcomes

  1. Best tumor response in accordance with Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC).

    Tumors will be assessed at screening, and tumor response will be assessed by the Investigator after Cycle 2 (± 1 week) has been completed and at the end of treatment (EOT) visit by positron emission tomography (PET)/computed tomography (CT) in accordance with LYRIC.

    Time frame: 12 Months

  2. Overall Survival (OS)

    OS will be evaluated using Kaplan-Meier methods. OS will be defined as the time from the date of first treatment to the date of death (any cause). Participants who are alive at the end of follow-up will be censored at the last known date alive.

    Time frame: 12 Months

07

Study locations

3 sites
  • FARMOVS
    Bloemfontein, Free State 9301, South Africa
  • Dr. Jackie Thomson Inc.
    Johannesburg, Gauteng 2193, South Africa
  • Albert Cellular Therapy
    Pretoria, Gauteng 0044, South Africa
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06334991
Lead sponsor
ImmunityBio, Inc.
Responsible party
Sponsor
First posted
Mar 28, 2024
Start date
Aug 23, 2024
Primary completion
Oct 2027 (estimated)
Completion
Oct 2027 (estimated)
Last update
Jul 10, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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