Phase
Condition
Lymphoma
Treatment
CD19 t-haNK
Clinical Study ID
Ages 18-99 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥ 18 years old.
Able to understand and provide a signed informed consent that fulfills the relevantHuman Research Ethics Committee (HREC) or Independent Ethics Committee (IEC)guidelines.
Histologically documented CD19- and CD20-positive B-cell NHL (excluding primary CNSlymphoma, 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 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.
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.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Expected survival > 16 weeks.
Stated willingness to comply with study procedures.
Able to attend required study visits and return for adequate followup, as requiredby this protocol.
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:
Histologically documented primary CNS lymphoma, CLL, Burkitt, or Burkitt-likelymphoma.
Known hypersensitivity to sulfa-containing study medication(s), includinganaphylactic reaction to sulfa-containing medications.
Known allergy to albumin (human) or dimethyl sulfoxide (DMSO).
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.
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.
History of allogeneic hematopoietic stem-cell transplantation (HSCT) requiringongoing 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 transplant who develop high grade lymphomas orleukemias.
CD19- and CD20-positive metastases to the CNS, including the parenchyma
Nonmalignant CNS disease (eg, stroke, epilepsy, vasculitis, or neurodegenerativedisease).
History of or active inflammatory bowel disease (eg, Crohn's disease, ulcerativecolitis).
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 participanthas 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 participantswith bone metastases).
Serum creatinine > 1.6 mg/dL.
Each study site should use its institutional ULN to determine eligibility.
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.
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.
Currently taking any medication(s) (herbal or prescribed) known to have an adversedrug 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 < 350cells/μL and a detectable HIV viral load.
Known carriers of hepatitis B virus (HBV) infection that is currently hepatitis Bsurface antigen (HBsAg) positive.
Concurrent active malignancy other than basal or squamous cell carcinomas of theskin.
Assessed by the Investigator to be unable or unwilling to comply with therequirements of the protocol.
Women who are pregnant or breastfeeding
Study Design
Study Description
Connect with a study center
FARMOVS
Bloemfonteun, Free State 9301
South AfricaActive - Recruiting
Dr. Jackie Thomson Inc.
Johannesburg, Gauteng 2193
South AfricaActive - Recruiting
Albert Cellular Therapy
Pretoria, Gauteng 0044
South AfricaActive - Recruiting
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