Study for Subjects with Relapsed/Refractory Non-Hodgkin Lymphoma

Last updated: January 10, 2025
Sponsor: ImmunityBio, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Lymphoma

Treatment

CD19 t-haNK

Clinical Study ID

NCT06334991
QUILT-106
  • Ages 18-99
  • All Genders

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥ 18 years old.

  2. Able to understand and provide a signed informed consent that fulfills the relevantHuman Research Ethics Committee (HREC) or Independent Ethics Committee (IEC)guidelines.

  3. Histologically documented CD19- and CD20-positive B-cell NHL (excluding primary CNSlymphoma, CLL, and Burkitt lymphoma) with the following specific criteria:

  4. Have completed ≥ 2 lines of cytotoxic chemotherapy.

  5. Have received rituximab or another anti-CD20 antibody.

  6. Have measurable disease by Lugano classification documented within 8 weeks ofthe time of consent, defined as nodal lesions > 15 mm in the long axis orextranodal lesions > 10 mm in long and short axis, or bone marrow involvementthat is biopsy proven.

  7. Have CD19- and CD20-positive disease confirmed on the diagnostic or repeatbiopsy specimen. A minimum of 5% CD19 and CD20 positivity byimmunohistochemistry or flow cytometry is required.

  8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.

  9. Expected survival > 16 weeks.

  10. Stated willingness to comply with study procedures.

  11. Able to attend required study visits and return for adequate followup, as requiredby this protocol.

  12. Agreement to practice effective contraception for female participants ofchildbearing potential and nonsterile males. Female participants of childbearingpotential 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 agreeto use a condom while on study and for up to 5 months after the last dose of studydrug. Effective contraception includes surgical sterilization (eg, vasectomy, tuballigation), two forms of barrier methods (eg, condom, diaphragm), and intrauterinedevices (IUDs).

Exclusion

Exclusion Criteria:

  1. Histologically documented primary CNS lymphoma, CLL, Burkitt, or Burkitt-likelymphoma.

  2. Known hypersensitivity to sulfa-containing study medication(s), includinganaphylactic 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 theinvestigational drug used in this study or that would put the participant at highrisk for treatment related complications.

  5. History of significant autoimmune disease OR active, uncontrolled autoimmunephenomenon: such as systemic lupus erythematous, Wegner's glomerulonephritis,autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura requiring steroidtherapy defined as > 20 mg of prednisone or equivalent daily.

  6. History of allogeneic hematopoietic stem-cell transplantation (HSCT) requiringongoing 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 orleukemias.

  10. CD19- and CD20-positive metastases to the CNS, including the parenchyma

  11. Nonmalignant CNS disease (eg, stroke, epilepsy, vasculitis, or neurodegenerativedisease).

  12. History of or active inflammatory bowel disease (eg, Crohn's disease, ulcerativecolitis).

  13. Inadequate organ function, evidenced by the following laboratory results:

  14. ANC < 1000 cells/mm3.

  15. Platelet count < 100,000 cells/mm3.

  16. Total bilirubin ≥ 1.5 × the upper limit of normal (ULN; unless the participanthas documented Gilbert's syndrome or indirect hyperbilirubinemia).

  17. Aspartate aminotransferase (AST [SGOT]/ALT (SGPT) ≥ 2.5 × ULN.

  18. Alkaline phosphatase (ALP) levels ≥ 2.5 × ULN (or ≥ 5 × ULN in participantswith bone metastases).

  19. Serum creatinine > 1.6 mg/dL.

  20. Each study site should use its institutional ULN to determine eligibility.

  21. Uncontrolled hypertension (systolic > 160 mm Hg and/or diastolic > 110 mm Hg) orclinically significant (ie, active) cardiovascular disease, cerebrovascularaccident/stroke, or myocardial infarction within 6 months prior to first studymedication; unstable angina; congestive heart failure of New York Heart Associationgrade 2 or higher; or serious cardiac arrhythmia requiring medication.

  22. Current chronic daily treatment (continuous for > 3 months) with systemiccorticosteroids defined as > 20 mg of prednisone or equivalent daily, excludinginhaled steroids. Short-term steroid use to prevent IV contrast allergic reaction oranaphylaxis in participants who have known contrast allergies is allowed.

  23. Currently taking any medication(s) (herbal or prescribed) known to have an adversedrug reaction with any of the study medications.

  24. Tested positive for tuberculosis (TB) utilizing the QuantiFERON Gold TB test.

  25. History of human immunodeficiency virus (HIV) with current CD4+ T-cell count < 350cells/μL and a detectable HIV viral load.

  26. Known carriers of hepatitis B virus (HBV) infection that is currently hepatitis Bsurface antigen (HBsAg) positive.

  27. Concurrent active malignancy other than basal or squamous cell carcinomas of theskin.

  28. Assessed by the Investigator to be unable or unwilling to comply with therequirements of the protocol.

  29. Women who are pregnant or breastfeeding

Study Design

Total Participants: 10
Treatment Group(s): 1
Primary Treatment: CD19 t-haNK
Phase: 1
Study Start date:
August 23, 2024
Estimated Completion Date:
March 30, 2027

Study 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 subjects with selected CD19+ and CD20+ R/R B-cell non-Hodgkin lymphoma (NHL).

Up to 10 subjects will receive at least 1 dose of study drug. The initial 3 subjects will receive study drug in a staggered fashion, with a 7 day interval between each subject to evaluate any toxicities.

Subjects will initially receive a single 3 week cycle of the CD19 t haNK as a single-agent regimen. Following a 1-week safety pause, subjects will then receive a 3 week cycle of CD19 t-haNK in combination with rituximab. Subjects will then undergo the first tumor assessment. Subjects 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.

Connect with a study center

  • FARMOVS

    Bloemfonteun, Free State 9301
    South Africa

    Active - Recruiting

  • Dr. Jackie Thomson Inc.

    Johannesburg, Gauteng 2193
    South Africa

    Active - Recruiting

  • Albert Cellular Therapy

    Pretoria, Gauteng 0044
    South Africa

    Active - Recruiting

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