CLIC-1901 for the Treatment of Patients With Relapsed/Refractory CD19 Positive Hematologic Malignancies

Exclusion Criteria

• •An individual who meets any of the following criteria will be excluded from participation in this study:
• •1. Isolated extra-medullary disease.
• •2. Participants with concomitant genetic syndrome, such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known familial bone marrow failure syndrome.
• •3. Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and with no evidence of active disease.
• •4. Prior treatment with any gene therapy product.
• •5. Participants with polymerase chain reaction (PCR) positive hepatitis B, hepatitis C, or Human Immunodeficiency Virus (tested within 8 weeks of screening), or any uncontrolled infection at screening.
• •6. Presence of active Graft Versus Host Disease requiring systemic therapy.
• •7. Participants who have undergone allogeneic SCT less than 6 months prior to CLIC-1901 cell infusion or who have undergone donor lymphocyte infusion less than 6 weeks prior to CLIC-1901 cell infusion.
• •8. Active Central Nervous System (CNS) involvement by malignancy, defined by CNS-3 per National Comprehensive Cancer Network guidelines.
• •9. History of anaphylaxis to gentamicin or its derivatives.
• •10. Participant has received an investigational agent within the 30 days prior to enrolment visit.
• •11. Pregnant or nursing women.