A Clinical Study of CHT101 in CD70-Positive Relapsed or Refractory Hematological Malignancies
NCT ID: NCT06914037
Last Updated: 2025-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1
24 participants
INTERVENTIONAL
2025-03-31
2028-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Clinical Study of CHT101 in CD70-Positive Advanced Solid Tumors
NCT06730659
Study of CT071 Injection in RRMM or PPCL
NCT05838131
SENL101 Autologous T Cell Injection in Adults With Relapsed or Refractory CD7+ Hematolymphoid Malignancies
NCT05398614
A Clinical Study of Anti-CD70 UCAR-T in Relapsed or Refractory Solid Tumors
NCT06383507
A Clinical Study of CHT102 in Mesothelin Positive Advanced Solid Tumors
NCT06717022
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CHT101
CD70 UCAR-T
CHT101
CD70 UCAR-T
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CHT101
CD70 UCAR-T
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Nanjing Calmhome Cell and Gene Engineering Institute Co., Ltd.
INDUSTRY
Tianjin Medical University Cancer Institute and Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CHT101HIIT-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.