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Relapsed B-Cell Non Hodgkin LymphomaPhase 2NCT07125872

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

A Phase 2 study testing CD19 t-haNK- IV Administration in people with Relapsed B-Cell Non Hodgkin Lymphoma, run by ImmunityBio, Inc. at 2 sites in South Africa.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Relapsed B-Cell Non Hodgkin Lymphoma
What is being tested?
CD19 t-haNK- IV Administration
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesSouth Africa
Study dates
11 Nov 2025to 25 May 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1- 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.
  • 4. Eastern Cooperative Oncology Group (ECOG) performance status (Appendix 5) of 0 to 1.
  • 5. 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.
  • 7. 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).

Who cannot join

  • 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.
Show all 28Show fewer
  • 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.
  • Participants post solid organ transplants who develop high grade lymphomas or leukemias.
  • Metastases to the CNS, including parenchyma or leptomeninges.
  • Nonmalignant CNS disease (e.g., stroke, epilepsy, vasculitis, or neurodegenerative disease).
  • History of active inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).
  • Uncontrolled hypertension (systolic > 160 mm Hg and/or diastolic > 110 mm Hg) or clinically significant (i.e., 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 (Appendix 6) Class 2 or higher; or serious cardiac arrhythmia requiring medication.
  • Current chronic daily treatment (continuous for >3 months) with systemiccorticosteroids 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.
  • Tested positive for tuberculosis (TB) utilizing the QuantiFERON Gold TB test.
  • History of human immunodeficiency virus (HIV) with current CD4+ T-cell count < 350 cells/μL and 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

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Atessa Kiani, MD contact

19499038749

atessa.kiani@immunitybio.com

Mark Nelson contact

mark.nelson@immunitybio.com

South Africa2 sites, 2 recruiting

  • Dr. Jackie Thomson Inc

    Johannesburg, 2193

    Suzan Blackstock, suzan@bonemarrowtransplant.co.za

    Jacqueline Thomson, MD

    Recruiting

  • Albert Cellular Therapy

    Pretoria, 0044

    Marieta Heymans, marietah@abj.org.za

    Marli Hanekom, marlih@abj.org.za

    Recruiting

Other trials in South Africa

About this study

Official title: Open Label, Phase 2 Study of CD19 t-haNK and N-803 in Combination With Rituximab in Participants With Relapsed/ Refractory B-cell Non- Hodgkin Lymphoma

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.

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.

Participants first receive chemo depletion chemo( Fludarabine and cyclophosphamide) for 3 consensual days, then subjects receive CD19 t-haNK, N-803 and Rituximab every 3 weeks for up to 6 cycles. If participants respond to treatment they will receive maintenance therapy from cycle 7 to 12. 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.

Each cycle has day 1 and 8 for treatment. On day one of each cycle the following will be conducted: Concomitant Medication, Physical Exam, Vitals, ECOG and Labs. The participants will receive phone call 6 hours(+/-2) and 24 (+/-4 hours) and 24 post infusion for AE collection during cycle 1.

Being tested
CD19 t-haNK- IV Administration
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

    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.

Study groups in NCT07125872
Study groupRoleWhat they receive
Open Label- Single ArmOtherStudy is open label: combination of SOC Chemo therapy and investigational products.
Receives: Biological: CD19 t-haNK- IV Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Endpoints( Efficacy)

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

    OS( Time from study treatment initiation to death)

    Measured: 6 months

Secondary outcomes (1)

  1. Secondary endpoints( Safety)

    Incidence of treatment- emergent adverse events( TEAEs) and serious adverse event(SAEs) graded using the National Cancer Institute( NCI) CTCAE Version 5.0, Clinically important changes in laboratory.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2025
  2. Study start11 Nov 2025
  3. Primary completion25 May 2027 (estimated)
  4. Study completion25 May 2028 (estimated)

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07125872
Sponsor's protocol ID
ResQ215A-BCELL
Status last verified
Oct 2025
First submitted
11 Aug 2025
Last updated
4 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CD19 t-haNK- IV Administration in people with Relapsed B-Cell Non Hodgkin Lymphoma, run by ImmunityBio, Inc. at 2 sites in South Africa.

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 7 inclusion and 28 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: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

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 Atessa Kiani, MD (19499038749, atessa.kiani@immunitybio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Endpoints( Efficacy) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07125872.

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 4 May 2026.

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