QUILT-3.061: CD19 t-haNK in Subjects With Diffuse Large B-Cell Lymphoma

Inclusion Criteria

• •1. Age ≥ 18 years old.
• •2. Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.
• •3. Have histologically confirmed DLBCL that is refractory or relapsed after at least 2 lines of previous therapy.
• •4. Are ineligible for autologous stem cell transplant, allogeneic stem cell transplant or CAR T cell therapy under 1 of the following conditions:
• •1. Have chemotherapy refractory disease after 2 lines of salvage chemotherapy.
• •2. Have met eligibility for CAR T-cell therapy or transplant, but have refused therapy.
• •5. Have disease progression or relapse within 12 months after autologous or allogeneic stem cell transplant or have relapsed following CAR T-cell therapy and meet the following criteria:
• •1. Had a partial response (PR) or stable disease (SD) at the 3-month disease assessment and then subsequently progressed \> 3 months after first CAR T-cell therapy.
• •2. Have confirmed CD19 tumor expression by biopsy after disease progression and prior to retreatment.
• •3. Have not received subsequent therapy for the treatment of lymphoma post CAR T-cell therapy.
• •4. Toxicities related to conditioning chemotherapy (fludarabine and cyclophosphamide), with the exception of alopecia, have resolved to ≤ grade 1 or returned to baseline prior to retreatment.
• •6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
• •7. Have at least 1 measurable lesion and/or non-measurable disease evaluable in accordance with RECIST Version 1.1.
• •8. Must have a recent formalin-fixed, paraffin-embedded (FFPE) tumor biopsy specimen obtained following the conclusion of the most recent anticancer treatment and be willing to release the specimen for exploratory tumor molecular profiling. If an historic specimen is not available, the subject must be willing to undergo a biopsy during the screening period, if considered safe by the Investigator. If safety concerns preclude collection of a biopsy during the screening period, a tumor biopsy specimen collected prior to the conclusion of the most recent anticancer treatment may be used.
• •9. Must be willing to provide pre- and post-infusion blood samples for exploratory analyses.
• •10. Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
• •11. Agreement to practice effective contraception for female subjects of child-bearing potential and non-sterile males. Female subjects of child-bearing potential must agree to use effective contraception while on study and for at least 5 months after the last dose of CD19 t-haNK for Infusion. Non-sterile male subjects must agree to use a condom while on study and for up to 5 months after the last dose of CD19 t-haNK for Infusion. Effective contraception includes surgical sterilization (eg, vasectomy, tubal ligation), two forms of barrier methods (eg, condom, diaphragm) used with spermicide, intrauterine devices (IUDs), and abstinence.