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Recruiting NCT06914037

A Clinical Study of CHT101 in CD70-Positive Relapsed or Refractory Hematological Malignancies

Phase I Interventional Peripheral T-cell Lymphoma Cutaneous T-cell Lymphoma (CTCL) NHL (Non-Hodgkin Lymphoma)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CHT101.
Who it may be relevant to
Registry conditions: Peripheral T-cell Lymphoma, Cutaneous T-cell Lymphoma (CTCL), NHL (Non-Hodgkin Lymphoma). Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug CHT101
    CD70 UCAR-T

Primary outcome measures

  • Dose-limiting toxicity (DLT) [Time frame: 28 days of first infusion of CHT101]
  • Maximum tolerated dose (MTD) [Time frame: 28 days of first infusion of CHT101]
Secondary outcome measures (7)
  • Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [Time frame: 2 years]
  • Objective response rate (ORR) [Time frame: 2 years]
  • Duration of response (DOR) [Time frame: 2 years]
  • Progression-free survival (PFS) [Time frame: 2 years]
  • Overall survival (OS) [Time frame: 2 years]
  • Pharmacokinetics (PK) [Time frame: 2 years]
  • Pharmacodynamics (PD) [Time frame: 2 years]

Eligibility criteria

Inclusion 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 failed ≥2 lines of systemic therapies.
  • 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.

Exclusion Criteria (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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Tianjin Medical University Cancer Institute & Hospital — Tianjin

Identifiers

NCT: NCT06914037 · CHT101HIIT-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗