UCD19 CAR T Therapy in Adults With B-ALL and MRD Positivity in CR1

Inclusion criteria

• ✓. Age: ≥ 18 years of age with no upper age limit
• ✓. ECOG Performance Status ≤ 2
• ✓. Confirmed B-cell ALL in first complete morphologic remission
• ✓. MRD positivity as defined by:
• ✓. For Ph- ALL: \> 0.01% by FACS or \> 0 clonal sequences by NGS (clonoSEQ). MRD assessment for eligibility must be at least 28 days after the start of SOC induction therapy. Remission-induction therapy must have consisted of multi-agent chemotherapy (≥ 3 systemic anti-leukemia chemotherapy agents).
• ✓. For Ph+ ALL: \> 0.01% by FACS, \> 0 clonal sequences by NGS (clonoSEQ), or less than complete molecular remission (undetectable BCR-ABL1 transcripts by RT-PCR assay with sensitivity of at least 1 in 100,000). MRD assessment for eligibility must be at least 57 days after the start of SOC induction therapy. Remission-induction therapy must have consisted of a BCR-ABL1 directed tyrosine kinase inhibitor and at least one other systemic anti-leukemia chemotherapy agent.
• ✓. Peripheral blood CD3 count must be \> 0.15 x 106 cells/mL within 21 days prior to proceeding with apheresis.
• ✓. Toxicities from prior therapy must be stable and recovered to ≤ Grade 2 (exceptions include non-clinically significant toxicities such as alopecia and the organ function definitions provided in inclusion criteria 7).