A Phase 1 Study of ADI-001 in B Cell Malignancies

Prior treatment

• Any of the following current conditions:
  • Active acute or chronic graft versus host disease (GvHD) other than grade 1 with skin involvement, or GvHD requiring immunosuppressive treatment within 4 weeks of enrollment
  • Any other acute or chronic medical or psychiatric condition that may increase the risk associated with study participation or investigational product administration
  • Tumor mass effects such as bowel obstruction or blood vessel compression that require therapy
  • Opportunistic infections

Other illness

• Current or history of any of the following conditions:
  • Central nervous system (CNS) primary lymphoma (current or history)
  • Unrelated malignancy requiring systemic treatment (current or history [in the past 3 years, other than hormonal treatment which is allowed])
• History of any clinically significant conditions in the opinion of the Investigator

Lab values

• Prior treatment with any of the following:
  • a Gene therapy, genetically modified cell therapy, or adoptive T cell therapy within 6 weeks of study enrollment.
  • b Radiation therapy within 4 weeks prior to study entry. Palliative local radiation may be allowed within 1 week prior to study entry.
  • c Autologous stem cell transplant (SCT) within 6 weeks of planned ADI 001 infusion.
  • d Allogeneic transplant and donor lymphocyte infusion within 3 months of planned CAR T cell infusion

Other

• Patients unwilling to participate in an extended safety monitoring period (long term follow up [LTFU] protocol)

• Relapsed/refractory (R/R) previously treated B cell malignancies.
• Prior treatment must include at least 2 prior regimens, including anti CD20 antibody therapies. Prior Treatment with CD19 CAR T may be considered.
• Documented measurable disease as defined by Lugano 2014
• Male or female ≥ 18 years of age
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1
• Adequate hematological, renal, pulmonary, cardiac, and liver function
• Female patients who are not pregnant or breastfeeding
• Female patients of childbearing potential and all male patients must agree to use highly effective methods of birth control for the duration of the study.