Phase I/II Study of Rapcabtagene Autoleucel in CLL, 3L+ DLBCL, r/r ALL and 1L HR LBCL

Prior treatment

• Prior CD19-directed therapy
• Prior administration of a genetically engineered cellular product
• Prior allogeneic HSCT
• Active CNS lymphoma
  • For 1L HR LBCL: Active or prior history CNS involvement by malignancy
• Targeted small molecule or kinase inhibitor within 2 weeks from leukapheresis
  • Other protocol-defined inclusion/exclusion may apply.

Other

• Richter's transformation
  • For 1L HR LBCL: Richter's transformation, Burkitt lymphoma, primary DLBCL of CNS, DLBCL associated with chronic inflammation, intravascular large B-cell lymphoma, ALK- positive large B-cell lymphoma, HHV8 positive LBCL, DLBCL leg type or EBV positive DLBCL, NOS.

• ECOG performance status 0-1 for ALL and DLBCL
• ECOG performance status 0-2 for 1L HR LBCL at screening
• CLL or SLL diagnosis according to iwCLL criteria
• CLL/SLL in SD or PR after at least 6 months of ibrutinib, either as second or subsequent line of therapy
• DLBCL diagnosis by local histopathology
• DLBCL relapsed or refractory after 2 or more lines of therapy, including autologous hematopoietic stem cell transplantation (HSCT)
• Refractory or relapsed CD19-positive ALL
• ALL with morphologic disease in the bone marrow
  • 1L HR LBCL - Considered to be high-risk based on at least 1 of the following at diagnosis:
  • IPI score of 3, 4 or 5
  • MYC and BCL2 and/or BCL6 rearrangement (DH/TH lymphoma)
• Participants must have received 2 cycles of frontline therapy for LBCL with R-CHOP or Pola-R-CHP or DA-EPOCH-R. Participants with DH/TH lymphoma must have received at least one cycle (the most recent) DA-EPOCH-R.
• Participants must have a positive PET per Lugano classification (Deauville PET score of 4 or 5 and an overall response of PR/SD) after 2 cycles of frontline CIT. Note: Patient's with Deauville PET score of 5 and overall response of PD, or with Deauville PET score of 1, 2, or 3 and overall response of CR, are not eligible for this trial.