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

Launched by TIANJIN MEDICAL UNIVERSITY CANCER INSTITUTE AND HOSPITAL · Mar 30, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called CHT101 for patients with specific types of blood cancers, including Peripheral T-cell Lymphoma, Cutaneous T-cell Lymphoma, and Non-Hodgkin Lymphoma. The main goals are to see how safe the treatment is, how the body processes it, and whether it helps patients whose cancer has not responded to previous therapies. The trial is currently recruiting participants who are between 18 to 70 years old and have a confirmed presence of a protein called CD70 in their cancer cells. Eligible patients should have already tried several other treatments without success.

If you join this trial, you will receive CHT101 and be closely monitored by the research team to track your health and any side effects. Participants will need to provide consent to join and agree to use effective birth control during the study and for two years afterward. This trial offers a potential new option for those dealing with challenging blood cancers and contributes to understanding better treatments for these conditions.

Gender

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Eligibility criteria

• 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.