Study for Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma
Trial Parameters
Eligibility Fast-Check
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Brief 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 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