Status:
RECRUITING
A Clinical Study of CHT101 in CD70-Positive Relapsed or Refractory Hematological Malignancies
Lead Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Collaborating Sponsors:
Nanjing Calmhome Cell and Gene Engineering Institute Co., Ltd.
Conditions:
Peripheral T-cell Lymphoma
Cutaneous T-cell Lymphoma (CTCL)
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
Evaluate the Safety, Pharmacokinetics and Efficacy of CHT101 in Subjects With Relapsed or Refractory T or B Cell Hematological Malignancies
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Inclusion Criteria (abbreviated):
- 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 Criteria (abbreviated):
- 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.
Exclusion
Key Trial Info
Start Date :
March 31 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2028
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06914037
Start Date
March 31 2025
End Date
March 31 2028
Last Update
April 6 2025
Active Locations (1)
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1
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China