A Phase 1, Open-Label, Single-Arm Study of the Safety, Pharmacokinetics and Efficacy of CHT101 in Subjects With Relapsed or Refractory T or B Cell Hematological Malignancies
Evaluate the Safety, Pharmacokinetics and Efficacy of CHT101 in Subjects With Relapsed or Refractory T or B Cell Hematological Malignancies
• Willing and able to provide written informed consent.
• Aged 18 to 70 years, male or female.
• Confirmed CD70 positive in tumor tissue by immunohistochemistry (IHC).
• Only the following subtypes of hematological malignancies with measurable disease will be enrolled:
‣ Peripheral T cell lymphoma (including peripheral T cell lymphoma NOS, angioimmunoblastic T cell lymphoma, anaplastic large cell lymphoma, etc.) who have failed ≥1 line of systemic therapy.
⁃ Cutaneous T cell lymphoma (including mycosis fungoides (MF) or Sézary syndrome (SS) \[stage ≥IIB with disease involving two or more compartments or single-compartment disease with large-cell transformation\]) who have failed ≥2 lines of systemic therapies.
⁃ Aggressive B cell lymphoma who are refractory or relapsed post ≥2 lines of systemic therapies which contain anti-CD20 antibody and anthracyclines.
⁃ Indolent B cell lymphoma who are refractory or relapsed post ≥2 lines of systemic therapies which contain anti-CD20 antibody.
⁃ Chronic lymphocytic leukemia (CLL) who are refractory or relapsed post ≥2 lines of systemic therapies which contain BTK inhibitor and BCL-2 inhibitor.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Estimated life expectancy ≥12 weeks.
• Female patients of childbearing potential and male patients must agree to use a highly effective method of contraception from signing ICF through 2 years after last CHT101 infusion.