NCT06730659

Brief Summary

Evaluate the safety and efficacy of CD70-targeting UCAR-T cells in the treatment of CD70-positive advanced solid tumors.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
158mo left

Started Apr 2024

Longer than P75 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 Progress14%
Apr 2024Apr 2039

Study Start

First participant enrolled

April 19, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 12, 2024

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2027

Expected
12 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2039

Last Updated

December 12, 2024

Status Verified

December 1, 2024

Enrollment Period

3 years

First QC Date

December 10, 2024

Last Update Submit

December 10, 2024

Conditions

Relapsed / Refractory Solid Tumor

Keywords

Allogeneic CAR-TSafetyEfficacyPK

Outcome Measures

Primary Outcomes (1)

  • Safety and Tolerability

    Treatment-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)

    2 years

Secondary Outcomes (6)

  • Objective response rate (ORR)

    28 days

  • Disease control rate (DCR)

    28 days

  • Progress-free survival(PFS)

    2 years

  • Overall survival (OS )

    3 years

  • pharmacokinetics (PK)

    6 months

  • +1 more secondary outcomes

Study Arms (1)

CHT101 infusion

EXPERIMENTAL

CHT 101 will be dosing by IV.

Biological: CHT101

Interventions

CHT101BIOLOGICAL

CHT101: CD 70 UCAR T

CHT101 infusion

Eligibility Criteria

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

You may qualify if:

  • Ability to understand and sign a written informed consent documen；
  • At the date of signing ICF, 18 \~70 years old, male or female；
  • Histopathological confirmed advanced or metastatic solid tumors patients who have failed to standard treatment or intolerance with standard treatment；
  • Positive CD70 expression;
  • At least one measurable lesion at baseline per RECIST version 1.1；
  • The expected survival time is more than 12 weeks;
  • ECOG 0-1 points;
  • Adequate organ functions;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, China

RECRUITING

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Xin Yao, Ph.D

CONTACT

+86-02223340123yaoxin1969@yahoo.com.cn

Study Design

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

Study Record Dates

First Submitted

December 10, 2024

First Posted

December 12, 2024

Study Start

April 19, 2024

Primary Completion (Estimated)

April 18, 2027

Study Completion (Estimated)

April 18, 2039

Last Updated

December 12, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)