Advanced Pancreatic CancersPhase 1CHAMPIONNCT06760364
A Clinical Study of CHT102 in MSLN-Positive Advanced Pancreatic Cancer
A Phase 1 study testing CHT102 in people with Advanced Pancreatic Cancers, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
Evaluate the safety and efficacy of mesothelin-targeting UCAR-T cells in the treatment of mesothelin-positive advanced pancreatic cancer Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Pancreatic Cancers
- What is being tested?
- CHT102
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteChina
- Study dates
- 25 Dec 2024to 24 Dec 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 pancreatic cancer patients who have failed to standard treatment or intolerance with standard treatment；
- Positive mesothelin 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 & Hospital
Tianjin
Jihui Hao, Ph.D, +86-02223340123, haojihui@tjmuch.com
Jihui Hao, Ph.D
About this study
Official title: A Single-Arm, Open-Label, Phase I Study of CHT102 for MSLN-Positive Advanced Pancreatic Cancer
Evaluate the safety and efficacy of mesothelin-targeting UCAR-T cells in the treatment of mesothelin-positive advanced pancreatic cancer
Read the detailed description
3 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
- Advanced Pancreatic Cancers
- Being tested
- CHT102
- Keywords
- Allogeneic CAR-T, Safety, Efficacy, PK
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHT102Drug
CHT 102 : MSLN UCAR-T.
| Study group | Role | What they receive |
|---|---|---|
| CHT102 infusion | Experimental | CHT102 will be dosing by arterial infusion. Receives: Drug: CHT102 |
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 total response rate after 90 days of treatment with study drug.
Measured: At 4 weeks, and overall
Disease control rate (DCR)
The disease control rate after 90 days of treatment with study drug.
Measured: At 4 weeks, and overall
Progress-free survival(PFS)
PFS will be assessed from the first CHT102 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 CHT102 infusion to death from any cause (Assessed based on RECIST criteria)
Measured: 3 years
pharmacokinetics (PK)
Concentration levels of MSLN+ CAR-T cells
Measured: 6 months
PD
Concentration levels of MSLN U CAR-T-related serum cytokines, such as IL-2, IL-4, IL-6, IL-10, IFN-γ, TNF-α, etal
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 posted6 Jan 2025
- Study start25 Dec 2024
- Primary completion24 Dec 2027 (estimated)
- Study completion24 Dec 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Pancreatic CancersStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- 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
- NCT06760364
- Sponsor's protocol ID
- CHT102SIIT-02
- Acronym
- CHAMPION
- Status last verified
- Nov 2024
- First submitted
- 29 Dec 2024
- Last updated
- 10 Apr 2025
- 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 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Open-Label, Phase I Study of CHT102 for MSLN-Positive Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT06760364
- Acronym / sponsor ID
- CHAMPION / CHT102SIIT-02
- Conditions
- Advanced Pancreatic Cancers
- Keywords
- Allogeneic CAR-T, Safety, Efficacy, PK
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 21 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
- 25 Dec 2024 (actual)
- Primary completion
- 24 Dec 2027 (estimated)
- Study completion
- 24 Dec 2039 (estimated)
- First posted
- 6 Jan 2025 (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 mesothelin-targeting UCAR-T cells in the treatment of mesothelin-positive advanced pancreatic cancer
Detailed description
3 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CHT102 infusion | Experimental | Drug: CHT102CHT102 will be dosing by arterial infusion. |
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 pancreatic cancer patients who have failed to standard treatment or intolerance with standard treatment；
- Positive mesothelin 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 |
|---|---|---|
| CHT102CHT 102 : MSLN UCAR-T. | Drug | CHT102 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: At 4 weeks, and overall
Disease control rate (DCR)
Time frame: At 4 weeks, and overall
Progress-free survival(PFS)
Time frame: 2 years
Overall survival (OS )
Time frame: 3 years
pharmacokinetics (PK)
Time frame: 6 months
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 10 Apr 2025.
- Individual participant dataSharing planned: No
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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 CHT102 in people with Advanced Pancreatic Cancers, 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 10 Apr 2025. 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 Jihui Hao, Ph.D (+86-02223340123, haojihui@tjmuch.com), 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 10 Apr 2025.