Evaluating CHT101 for patients with specific blood cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical study aims to assess the safety, pharmacokinetics, and efficacy of CHT101 in patients with relapsed or refractory hematological malignancies that are CD70-positive. The study will involve three planned dose cohorts during a dose escalation phase, followed by a dose expansion phase after a safety review committee evaluates the initial data. Participants will be closely monitored for their response to the treatment and any adverse effects.

Why it matters

Who can join: the full rules

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.

Where it's running

• Tianjin Medical University Cancer Institute & Hospital
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Study coordinator: Huilai Zhang
• Email: huilaizhangtz@163.com
• Phone: +86-18622221228

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.