Recruiting
Phase 1
A Clinical Study of CHT101 in CD70-Positive Relapsed or Refractory Hematological Malignancies
About this study
Evaluate the Safety, Pharmacokinetics and Efficacy of CHT101 in Subjects With Relapsed or Refractory T or B Cell Hematological Malignancies
- Condition
- Peripheral T-cell Lymphoma, Cutaneous T-cell Lymphoma (CTCL), NHL (Non-Hodgkin Lymphoma)
- Tested
- CHT101
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
Who can join
- Age
- 18 to 70 years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 15
- Minimum age: 18 years
- Maximum age: 70 years
- Study condition: Peripheral T-cell Lymphoma, Cutaneous T-cell Lymphoma (CTCL), NHL (Non-Hodgkin Lymphoma)
- 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.
Exclusion 6
- History or presence of CNS metastasis, or clinically relevant CNS pathology such as seizure, stroke, severe brain injury, etc.
- History of solid organ transplantation.
- Prior treatment with CD70-targeting agents.
- Prior treatment with CAR-T or other cellular/gene therapies.
- Ongoing bacterial, viral or fungal infection requiring systemic anti-infectives.
- Active autoimmune disease requiring immunosuppression.
Where
1 site, 1 recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
Contact
-
Huilai Zhang
+86-18622221228 huilaizhangtz@163.com
Potential match only. Final eligibility is determined by the study team.