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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Open-Label, Phase I Study of CHT101 for CD70-Positive Relapsed/Refractory Solid Tumors
- ClinicalTrials.gov ID
- NCT06730659
- Acronym / sponsor ID
- CHT101SIIT-05
- Conditions
- Relapsed / Refractory Solid Tumor
- Keywords
- Allogeneic CAR-T, Safety, Efficacy, PK
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Collaborators
- Nanjing Calmhome Cell and Gene Engineering Institute Co., Ltd.
- Study start
- 19 Apr 2024 (actual)
- Primary completion
- 18 Apr 2027 (estimated)
- Study completion
- 18 Apr 2039 (estimated)
- First posted
- 12 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the safety and efficacy of CD70-targeting UCAR-T cells in the treatment of CD70-positive advanced solid tumors.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CHT101 infusion | Experimental | Biological: CHT101CHT 101 will be dosing by IV. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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；
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHT101CHT101: CD 70 UCAR T | Biological | CHT101 infusion |
Primary outcome
Safety and Tolerability
Time frame: 2 years
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)
6 secondary outcomes
Objective response rate (ORR)
Time frame: 28 days
Disease control rate (DCR)
Time frame: 28 days
Progress-free survival(PFS)
Time frame: 2 years
Overall survival (OS )
Time frame: 3 years
pharmacokinetics (PK)
Time frame: 6 months
Pharmacodynamics (PD)
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Relapsed / Refractory Solid Tumor
RecruitingEarly Phase 1
KSX01-TCRT Injection Project in Solid Tumors
TCR-T Cells, Refractory Solid Tumors
RecruitingPhase 1
A Study of Codrituzumab in Children and Young Adults With Solid Tumors and Have Not Responded to Treatment or Have Come Back After Treatment
Primary Extra-cranial Solid Tumor, Recurrent or Refractory Glypican 3 (GPC3)
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingEarly Phase 1
KSH01-TCRT Solid Tumors
TCR-T Cells, Refractory Solid Tumors
RecruitingPhase 1/2
A Study of Ifinatamab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors (MK-9999-01D/LIGHTBEAM-U01)
Malignant Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xin Yao, Ph.D (+86-02223340123, yaoxin1969@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.