NCT06914037

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
24mo left

Started Mar 2025

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress37%
Mar 2025Mar 2028

First Submitted

Initial submission to the registry

March 30, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

March 31, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 6, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2028

Last Updated

April 6, 2025

Status Verified

March 1, 2025

Enrollment Period

3 years

First QC Date

March 30, 2025

Last Update Submit

March 30, 2025

Conditions

Peripheral T-cell LymphomaCutaneous T-cell Lymphoma (CTCL)NHL (Non-Hodgkin Lymphoma)

Outcome Measures

Primary Outcomes (2)

  • Dose-limiting toxicity (DLT)

    Safety

    28 days of first infusion of CHT101

  • Maximum tolerated dose (MTD)

    Tolerability

    28 days of first infusion of CHT101

Secondary Outcomes (7)

  • Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    2 years

  • Objective response rate (ORR)

    2 years

  • Duration of response (DOR)

    2 years

  • Progression-free survival (PFS)

    2 years

  • Overall survival (OS)

    2 years

  • +2 more secondary outcomes

Study Arms (1)

CHT101

EXPERIMENTAL

CD70 UCAR-T

Drug: CHT101

Interventions

CHT101DRUG

CD70 UCAR-T

CHT101

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, T-Cell, PeripheralLymphoma, T-Cell, CutaneousLymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Lymphoma, T-CellLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Central Study Contacts

Huilai Zhang

CONTACT

+86-18622221228huilaizhangtz@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2025

First Posted

April 6, 2025

Study Start

March 31, 2025

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

March 31, 2028

Last Updated

April 6, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)