A Clinical Study of CHT101 in CD70-Positive Relapsed or Refractory Hematological Malignancies

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

3 planned dose cohorts will be evaluated during dose escalation phase. The dose expansion will be initiated after SRC (safety review committee) reviewing available safety, PK and preliminary efficacy data.

Inclusion Criteria (abbreviated):

1. Willing and able to provide written informed consent.

2. Aged 18 to 70 years, male or female.

3. Confirmed CD70 positive in tumor tissue by immunohistochemistry (IHC).

4. Only the following subtypes of hematological malignancies with measurable disease will be enrolled:

   1. 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.
   2. 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.
   3. Aggressive B cell lymphoma who are refractory or relapsed post ≥2 lines of systemic therapies which contain anti-CD20 antibody and anthracyclines.
   4. Indolent B cell lymphoma who are refractory or relapsed post ≥2 lines of systemic therapies which contain anti-CD20 antibody.
   5. Chronic lymphocytic leukemia (CLL) who are refractory or relapsed post ≥2 lines of systemic therapies which contain BTK inhibitor and BCL-2 inhibitor.

5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

6. Estimated life expectancy ≥12 weeks.

7. 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.

Exclusion Criteria (abbreviated):

1. History or presence of CNS metastasis, or clinically relevant CNS pathology such as seizure, stroke, severe brain injury, etc.
2. History of solid organ transplantation.
3. Prior treatment with CD70-targeting agents.
4. Prior treatment with CAR-T or other cellular/gene therapies.
5. Ongoing bacterial, viral or fungal infection requiring systemic anti-infectives.
6. Active autoimmune disease requiring immunosuppression.