Clinical trial NCT06914037: A Clinical Study of CHT101 in CD70-Positive Relapsed or Refractory Hematological Malignancies
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Peripheral T-cell Lymphoma
Cutaneous T-cell Lymphoma (CTCL)
NHL (Non-Hodgkin Lymphoma)
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
Collaborators: name: Nanjing Calmhome Cell and Gene Engineering Institute Co., Ltd.
First posted: 2025-04-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluate the Safety, Pharmacokinetics and Efficacy of CHT101 in Subjects With Relapsed or Refractory T or B Cell Hematological Malignancies

Detailed description: 3 planned dose cohorts will be evaluated during dose escalation phase. The dose expansion will be initiated after SRC (safety review committee) reviewing available safety, PK and preliminary efficacy data.

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.

Primary outcomes:
measure: Dose-limiting toxicity (DLT)
timeFrame: 28 days of first infusion of CHT101
measure: Maximum tolerated dose (MTD)
timeFrame: 28 days of first infusion of CHT101
Secondary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
timeFrame: 2 years
measure: Objective response rate (ORR)
timeFrame: 2 years
measure: Duration of response (DOR)
timeFrame: 2 years
measure: Progression-free survival (PFS)
timeFrame: 2 years
measure: Overall survival (OS)
timeFrame: 2 years
measure: Pharmacokinetics (PK)
timeFrame: 2 years
measure: Pharmacodynamics (PD)
timeFrame: 2 years
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital
state: Tianjin
Study officials:
References: