A Study of CTD402 in T-ALL/LBL Patients

Prior treatment

• Participants with concomitant genetic syndromes associated with bone marrow failure states or any other known bone marrow failure syndrome.

Other illness

• Participants with following cardiac conditions will be excluded:
  • History of heart failure New York Heart Association (NYHA) class III or IV;
  • History of myocardial infarction, cardiovascular angioplasty or stenting, unstable angina, or other serious heart diseases within 12 months of enrollment.
• Presence of uncontrolled infections.
• Known history of infection with the human immunodeficiency virus (HIV); hepatitis C virus and syphilis.
• Active or latent hepatitis B virus infection

Other

• Active central nervous system (CNS) involvement
• Primary immune deficiency.
• Epstein-Barr virus (EBV), Cytomegalovirus (CMV) DNA or IgM positive at screening.

• Male or female, ≥ 1 year of age.
• Participants with body weight ≥ 40 kilogram.
• A) Relapsed or refractory T-ALL/LBL or MRD positive defined as one of the following:
  • Relapsed or refractory disease after two or more lines of systemic therapy;
  • The first relapse occurs within 12 months after first remission;
  • Relapse after allogeneic HSCT and must be ≥100 days from HSCT prior to screening period.
  • Minimal Residual Disease (MRD) positive T-ALL/LBL is defined as evidence of MRD, defined as \< 5% blasts in bone marrow but ≥ 1 cancer cell in 1,000 cells determined by NGS ClonoSEQ® and/or other regionally acceptable methodologies (e.g., EuroMRD guidelines).
• The presence of bone marrow lymphoblasts is ≥ 5% as determined by morphologic evaluation or evidence of extramedullary disease at screening.
• Adequate organ function
• ECOG of 2 or less or Karnofsky PS ≥ 60 (for participants age ≥ 16) or Lansky PS ≥ 60 (for participants \< 16) at screening.