NCT06914037 A Clinical Study of CHT101 in CD70-Positive Relapsed or Refractory Hematological Malignancies
| NCT ID | NCT06914037 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital |
| Condition | Peripheral T-cell Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2025-03-31 |
| Primary Completion | 2028-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 24 participants in total. It began in 2025-03-31 with a primary completion date of 2028-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Evaluate the Safety, Pharmacokinetics and Efficacy of CHT101 in Subjects With Relapsed or Refractory T or B Cell Hematological Malignancies
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06914037 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Peripheral T-cell Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06914037 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06914037 currently recruiting?
Yes, NCT06914037 is actively recruiting participants. Contact the research team at huilaizhangtz@163.com for enrollment information.
Where is the NCT06914037 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT06914037 clinical trial?
NCT06914037 is sponsored by Tianjin Medical University Cancer Institute and Hospital. The trial plans to enroll 24 participants.