Relapsed / Refractory Solid TumorPhase 1NCT06730659
A Clinical Study of CHT101 in CD70-Positive Advanced Solid Tumors
A Phase 1 study testing CHT101 in people with Relapsed / Refractory Solid Tumor, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
Evaluate the safety and efficacy of CD70-targeting UCAR-T cells in the treatment of CD70-positive advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Relapsed / Refractory Solid Tumor
- What is being tested?
- CHT101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 19 Apr 2024to 18 Apr 2039
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin
Xin Yao, Ph.D, +86-02223340123, yaoxin1969@yahoo.com.cn
About this study
Official title: A Single-Arm, Open-Label, Phase I Study of CHT101 for CD70-Positive Relapsed/Refractory Solid Tumors
Evaluate the safety and efficacy of CD70-targeting UCAR-T cells in the treatment of CD70-positive advanced solid tumors.
Read the detailed description
4 planned dose cohorts will be evaluated during dose escalation phase. The dose expansion will be initiated after SRC (safety review committee) review the avaliable safety, PK and preliminary efficacy data.
- Conditions
- Relapsed / Refractory Solid Tumor
- Being tested
- CHT101
- Keywords
- Allogeneic CAR-T, Safety, Efficacy, PK
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHT101Biological
CHT101: CD 70 UCAR T
| Study group | Role | What they receive |
|---|---|---|
| CHT101 infusion | Experimental | CHT 101 will be dosing by IV. Receives: Biological: CHT101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2 years
Secondary outcomes (6)
Objective response rate (ORR)
The proportion of subjects who achieved CR, PR after CAR-T infusion accounted for all treated subjects (Assessed based on RECIST criteria)，the minimum value is 0%，maximum value is 100%, and higher scores mean a better outcome.
Measured: 28 days
Disease control rate (DCR)
The proportion of subjects who achieved CR, PR, SD after CAR-T infusion accounted for all treated subjects (Assessed based on RECIST criteria)，the minimum value is 0%，maximum value is 100%, and higher scores mean a better outcome.
Measured: 28 days
Progress-free survival(PFS)
PFS will be assessed from the first CD70 UCAR-T cell infusion to death from any cause or the first assessment of progression (Assessed based on RECIST criteria)
Measured: 2 years
Overall survival (OS )
OS will be assessed from the first CD70 UCAR-T cell infusion to death from any cause (Assessed based on RECIST criteria)
Measured: 3 years
pharmacokinetics (PK)
Concentration levels of CD70+ CAR-T cells
Measured: 6 months
Pharmacodynamics (PD)
Concentration levels of CD70 U CAR-T-related serum cytokines, such as IL-2, IL-4, IL-6, IL-10, IFN-γ, TNF-α
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start19 Apr 2024
- Primary completion18 Apr 2027 (estimated)
- Study completion18 Apr 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed / Refractory Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Nanjing Calmhome Cell and Gene Engineering Institute Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06730659
- Sponsor's protocol ID
- CHT101SIIT-05
- Status last verified
- Dec 2024
- First submitted
- 10 Dec 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No