Follicular Lymphoma Clinical Trials

• 1\. Age ≥12 years and weight ≥40 kg;

• 2\. Histologically confirmed diagnosis per 2016 World Health Organization (WHO) classification of lymphoid neoplasms160 and per the 2016 WHO classification of acute leukemia161 of the following indications:

⁃ DLBCL, including arising from follicular lymphoma;

⁃ High-grade B-cell lymphoma;

⁃ MCL;

⁃ Primary mediastinal large B-cell lymphoma;

⁃ Primary DLBCL of the CNS;

⁃ Burkitt or Burkitt-like lymphoma/leukemia;

⁃ CLL/SLL; or

⁃ B-lymphoblastic leukemia/lymphoma, T-lymphoblastic leukemia/lymphoma, acute leukemia/lymphoma, acute leukemias of ambiguous lineage, or NK cell lymphoblastic leukemia/lymphoma;

‣ 3\. Patients must have relapsed or refractory (R/R) disease with prior therapies defined below:

⁃ DLBCL and high-grade B-cell lymphoma:

‣ e) R/R after autologous hematopoietic cell transplant (HCT); or f) R/R after chimeric antigen receptor T-cell (CAR T) therapy; or g) Patients not eligible for autologous HCT or CAR T therapy; or h) R/R after ≥2 lines of therapy including anti-CD20 antibody and failed, intolerant or ineligible for polatuzamab vedotin, or for whom no standard therapy is available.

⁃ MCL:

‣ c) R/R after autologous HCT; or d) Patients not eligible for autologous HCT must have failed acalabrutinib or be R/R after ≥2 lines of therapy including at least 1 of the following: a Bruton's tyrosine kinase (BTK) inhibitor, bortezomib, or lenalidomide; or for whom no standard therapy is available;

⁃ Primary mediastinal large B-cell lymphoma: R/R after ≥1 line of therapy and are not eligible for or have recurred after autologous HCT or CAR T cell therapy, or for whom no standard therapy is available;

⁃ Primary DLBCL of the CNS: R/R after ≥1 line of therapy including methotrexate (unless intolerant to methotrexate) and are not eligible for or have recurred after autologous HCT or CAR T cell therapy, or for whom no standard therapy is available;

⁃ Burkitt or Burkitt-like lymphoma/leukemia: R/R after ≥1 line of therapy including methotrexate (unless intolerant to methotrexate) and are not eligible for or have recurred after autologous HCT or CAR T cell therapy, or for whom no standard therapy is available;

⁃ CLL/SLL: patients who have active disease requiring treatment and who are deemed at high-risk for disease progression by the investigator or have high risk features per the iwCLL criteria, such as primary resistance to first-line chemo(immune)therapy, or progression of disease \<3 years after fludarabine-based chemo(immune)therapy, or leukemia cells with del(17p)/TP53 mutation, must be:

‣ d) R/R after autologous or allogeneic HCT; or e) Patients not eligible for HCT; or f) R/R after ≥2 lines of therapy including at least 1 of the following: a BTK inhibitor, venetoclax, idelalisib, or duvelisib, or for whom no standard therapy is available;

⁃ Acute lymphoblastic leukemia (ALL):

‣ c) R/R after allogeneic HCT and for whom no standard therapy is available; or d) Patients not eligible for allogeneic HCT must be R/R according to the following disease specific specifications:

⁃ B-cell lymphoblastic leukemia/lymphoma: ≥2 lines of therapy including approved CAR T cell therapies, inotuzumab ozogamicin, or blinatumomab, or for whom no standard therapy is available;

⁃ T-cell lymphoblastic leukemia/lymphoma: ≥2 lines of therapy including nelarabine, or for whom no standard therapy is available;

⁃ NK cell leukemia/lymphoma: ≥1 line of therapy or for whom no standard therapy is available;

⁃ All other diagnoses: R/R after autologous or allogeneic HCT; or R/R after at least one line of therapy, or for whom no standard therapy is available.

‣ 4\. Lansky (12 to 15 years of age) (Appendix G) or Karnofsky (≥16 years of age) (Appendix H) performance status ≥50;

‣ 5\. Screening laboratory values that meet all of the following criteria:

⁃ Absolute neutrophil count ≥0.05 × 109/L;

⁃ Platelet count ≥25 × 109/L;

⁃ Hemoglobin ≥6.5 g/dL;

⁃ • Aspartate aminotransferase or alanine aminotransferase ≥2.5 × ULN, unless due to the disease;

⁃ Total bilirubin \<1.5 × ULN (if secondary to Gilbert's syndrome, \<3 × ULN is permitted), unless due to the disease; and

⁃ Glomerular filtration rate ≥30 mL/min ; except for patients on metformin at baseline GFR must be ≥45 mL/min; GFR can be calculated by the Cockcroft-Gault formula Appendix C);

‣ 6\. Minimum level of pulmonary reserve defined as \<Grade 2 dyspnea and pulse oximetry ≥92% on room air;

‣ 7\. Females of childbearing potential must have a negative serum pregnancy test at screening. Females of childbearing potential and nonsterile males must agree to use medically effective methods of contraception from the time of informed consent/assent through 1 month after study drug infusion, which must, at a minimum, include a barrier method; and

‣ 8\. The ability to understand and willingness to sign a written informed consent form (ICF) and the ability to adhere to the study schedule and prohibitions. Patients under the age of 18 years (or other age as defined by regional law or regulation) must be willing and able to provide written assent and have a parent(s) or guardian(s) willing and able to provide written, signed informed consent after the nature of the study has been explained and prior to performance of any study-related procedure.