Actively Recruiting
A Phase 1, Open-Label, Single-Arm Study of CHT101 in CD70-Positive Relapsed or Refractory T or B Cell Hematological Malignancies
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2025-04-06
24
Participants Needed
1
Research Sites
N/A
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
Researchers are studying the safety, how the body processes, and effectiveness of a drug called CHT101 in adults aged 18 to 70 who have certain types of relapsed or refractory blood cancers, including Peripheral T-cell Lymphoma, Cutaneous T-cell Lymphoma, and Non-Hodgkin Lymphoma. This research is a Phase 1, open-label, single-arm study aiming to find the best dose and observe initial effects in these patients. The treatment involves giving CHT101, a CD70-targeted UCAR-T cell therapy, to participants. The study starts with a dose escalation phase where three dose levels will be tested. After a safety review committee evaluates safety, drug levels in the body, and early responses, a dose expansion phase will begin to further assess the treatment. Participants will be closely monitored for side effects, treatment responses, and how the drug moves and acts in the body over two years. Researchers will measure dose-limiting toxicity and maximum tolerated dose within 28 days of the first infusion. Other outcomes include adverse events, response rates, progression-free survival, overall survival, pharmacokinetics, and pharmacodynamics. Safety and effectiveness will be followed for up to two years after treatment begins.
CONDITIONS
Brief 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 tumor tissue by immunohistochemistry.
- Diagnosed with one of the following with measurable disease:
- Peripheral T cell lymphoma after failing at least one systemic therapy.
- Cutaneous T cell lymphoma (stage IIB or higher) after failing at least two systemic therapies.
- Aggressive B cell lymphoma refractory or relapsed after at least two systemic therapies including anti-CD20 and anthracyclines.
- Indolent B cell lymphoma refractory or relapsed after at least two systemic therapies including anti-CD20.
- Chronic lymphocytic leukemia refractory or relapsed after at least two systemic therapies including BTK and BCL-2 inhibitors.
- ECOG performance status of 0-1.
- Estimated life expectancy of at least 12 weeks.
- Agreement to use highly effective contraception from consent through 2 years after last infusion (for females of childbearing potential and males).
You will not qualify if you...
- History or presence of CNS metastasis or relevant CNS conditions like 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/gene therapies.
- Ongoing bacterial, viral, or fungal infection requiring systemic anti-infective treatment.
- Active autoimmune disease requiring immunosuppressive therapy.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At least 28 days after first infusion, with continued treatment as determined by safety and efficacy assessments
Participants receive CHT101 infusions as part of dose escalation and expansion to treat CD70-positive relapsed or refractory hematological malignancies.
Multiple visits during dose escalation and expansion phases for dosing and assessments
Duration - Up to 2 years
Participants are monitored for safety, response, and survival outcomes for up to 2 years after treatment.
Regular visits for safety and efficacy assessments over 2 years
Trial Site Locations
Total: 1 location
1
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
Research Team
H
Huilai Zhang
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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