Actively Recruiting
A Clinical Study of CHT101 in CD70-Positive Relapsed or Refractory Hematological Malignancies
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2025-04-06
24
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
T
Tianjin Medical University Cancer Institute and Hospital
Lead Sponsor
N
Nanjing Calmhome Cell and Gene Engineering Institute Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Evaluate the Safety, Pharmacokinetics and Efficacy of CHT101 in Subjects With Relapsed or Refractory T or B Cell Hematological Malignancies
CONDITIONS
Official Title
A Clinical Study of CHT101 in CD70-Positive Relapsed or Refractory Hematological Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent.
- Aged 18 to 70 years, male or female.
- Confirmed CD70 positive in tumor tissue by immunohistochemistry.
- Diagnosed with one of the following subtypes of hematological malignancies with measurable disease: peripheral T cell lymphoma who failed 1 line of systemic therapy; cutaneous T cell lymphoma (stage IIB with disease involving two or more compartments or single-compartment disease with large-cell transformation) who failed 2 lines of systemic therapies; aggressive B cell lymphoma refractory or relapsed after 2 lines of systemic therapies including anti-CD20 antibody and anthracyclines; indolent B cell lymphoma refractory or relapsed after 2 lines of systemic therapies including anti-CD20 antibody; chronic lymphocytic leukemia refractory or relapsed after 2 lines of systemic therapies including BTK inhibitor and BCL-2 inhibitor.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Estimated life expectancy of at least 12 weeks.
- Female patients of childbearing potential and male patients agree to use highly effective contraception from signing consent through 2 years after last CHT101 infusion.
You will not qualify if you...
- History or presence of central nervous system metastasis or clinically relevant CNS conditions such as seizure, stroke, or severe brain injury.
- History of solid organ transplantation.
- Prior treatment with CD70-targeting agents.
- Prior treatment with CAR-T or other cellular or gene therapies.
- Ongoing bacterial, viral, or fungal infection needing systemic anti-infective treatment.
- Active autoimmune disease requiring immunosuppressive therapy.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
Research Team
H
Huilai Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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