Evaluating CHT101 for patients with specific blood cancers

A Phase 1, Open-Label, Single-Arm Study of the Safety, Pharmacokinetics and Efficacy of CHT101 in Subjects With Relapsed or Refractory T or B Cell Hematological Malignancies

This study is testing a new treatment called CHT101 to see if it can help people with certain types of blood cancers that have come back or didn’t respond to other treatments.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Tianjin Medical University Cancer Institute and Hospital (Academic / other)
• Drugs / interventions: CAR-T
• Locations: 1 site (Tianjin, Tianjin Municipality)
• Trial ID: NCT06914037 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with confirmed CD70-positive hematological malignancies who have not responded to previous treatments.

Not a fit: Patients with hematological malignancies that are not CD70-positive or those who have not undergone the required lines of prior therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat hematological malignancies.

How similar studies have performed: While this approach is novel in targeting CD70-positive malignancies, similar studies targeting specific markers in hematological cancers have shown promise.

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.

Where this trial is running

Tianjin, Tianjin Municipality

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

Study contacts

• Study coordinator: Huilai Zhang

Conditions Peripheral T-cell Lymphoma; Cutaneous T-cell Lymphoma; NHL