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New treatment option for Peripheral T-cell Lymphoma
Official title A Clinical Study of CHT101 in CD70-Positive Relapsed or Refractory Hematological Malignancies
ClinicalTrials.gov ID: NCT06914037
What this study is testing
What is CHT101?
CHT101 is an investigational medicine, being studied as a potential treatment for peripheral t-cell lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Evaluate the Safety, Pharmacokinetics and Efficacy of CHT101 in Subjects With Relapsed or Refractory T or B Cell Hematological Malignancies
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- (abbreviated):
- Willing and able to provide written informed consent.
- Aged 18 to 70 years, male or female.
- Confirmed CD70 positive in tumor tissue by immunohistochemistry (IHC).
- Only the following subtypes of hematological malignancies with measurable disease will be enrolled:
You likely can't join if
- (abbreviated):
- History or presence of CNS metastasis, or clinically relevant CNS pathology such as seizure, stroke, severe brain injury, etc.
- History of solid organ transplantation.
- Prior treatment with CD70-targeting agents.
- Prior treatment with CAR-T or other cellular/gene therapies.
- Ongoing bacterial, viral or fungal infection requiring systemic anti-infectives.
See the full eligibility criteria
- (abbreviated):
- Willing and able to provide written informed consent.
- Aged 18 to 70 years, male or female.
- Confirmed CD70 positive in tumor tissue by immunohistochemistry (IHC).
- Only the following subtypes of hematological malignancies with measurable disease will be enrolled:
- 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.
- 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...
- Aggressive B cell lymphoma who are refractory or relapsed post ≥2 lines of systemic therapies which contain anti-CD20 antibody and anthracyclines.
- Indolent B cell lymphoma who are refractory or relapsed post ≥2 lines of systemic therapies which contain anti-CD20 antibody.
- Chronic lymphocytic leukemia (CLL) who are refractory or relapsed post ≥2 lines of systemic therapies which contain BTK inhibitor and BCL-2 inhibitor.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Estimated life expectancy ≥12 weeks.
- 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.
- (abbreviated):
- History or presence of CNS metastasis, or clinically relevant CNS pathology such as seizure, stroke, severe brain injury, etc.
- History of solid organ transplantation.
- Prior treatment with CD70-targeting agents.
- Prior treatment with CAR-T or other cellular/gene therapies.
- Ongoing bacterial, viral or fungal infection requiring systemic anti-infectives.
- Active autoimmune disease requiring immunosuppression.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.