Mesothelin Positive TumorsNCT06717022
A Clinical Study of CHT102 in Mesothelin Positive Advanced Solid Tumors
A study testing CHT102 allogeneic CAR T cells in people with Mesothelin Positive Tumors, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
Objectives of Study：In this study investigators plan to evaluate the safety and efficacy of MSLN-targeting Universal Chimeric Antigen Receptor T-Cell Immunotherapy(U CAR-T) in the treatment of MSLN-positive advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mesothelin Positive Tumors
- What is being tested?
- CHT102 allogeneic CAR T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 6 May 2024to May 2039
- Phase
- Interventional
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to understand and sign a written informed consent document；
- Age ≥18 years old, male or female；
- Histopathological confirmed advanced or metastatic solid tumors failed to at least standard first-line therapy or initially diagnosed advanced solid tumors that have no National Comprehensive Cancer Network (NCCN ）guideline recommended standard first-line therapy；
- Histopathology or cytology (paraffin section or fresh biopsy tumor tissue specimen) diagnosed as advanced/metastatic solid tumor (positive tumor MSLN expression (tumor MSLN positive (IHC 2+) confirmed by histology or pathology));
- At least one measurable lesion at baseline per RECIST version 1.1；
- The expected survival time is more than 12 weeks;
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- ECOG(American Eastern Oncology Consortium) 0-1 points;
- The function of important organs is basically normal;
- The investigator determines that the patient must have fully recovered from previous treatment toxicity to ≤ grade 1, except in the following cases: a. Hair loss; b. Pigmentation; c. Long-term toxicity caused by radiotherapy, which could not be recovered according to the investigators; d. Platinum induced grade 2 or lower neurotoxicity (CTCAE 5.0);
- Subjects agree to use reliable and effective contraceptive methods for contraception within
- 6 months after signing the informed consent form to receiving CAR-T cell infusion (excluding rhythm contraception).
Who cannot join
- Received any experimental drug treatment or used experimental devices within 28 days;
- Received anti-tumor therapy such as chemotherapy and targeted therapy within 4 weeks;
- Received cell therapy products other than MSLN targets within 1 month;
- Patients who have previously received other cell therapy products should be tested for RCL(Replication Competent Retrovirus ) during the screening period if any test result is positive;
- Received chemotherapy other than lymphocyte clearance chemotherapy within 14 days prior to CHT102 infusion;
- Received systemic corticosteroid therapy at doses greater than 10 mg/day prednisone (or equivalent doses of other corticosteroids) within 2 weeks；
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- Patients receiving oral or intravenous anticoagulant therapy within 7 days prior to CHT102 cell infusion;
- Prior organ allograft transplantations or allogeneic hematopoietic stem cell transplantation;
- Patients with immune deficiency or autoimmune diseases, or who require immunosuppressants;
- Vaccination within 14 days of study enrollment, or who required live vaccine immunization during the study period;
- Active/symptomatic central nervous system metastases or meningeal metastases at the time of screening; subjects with brain metastases who have been treated must be confirmed to have no imaging evidence of progression ≥ 4 weeks after the end of treatment before they can be enrolled;
- Serious or uncontrollable systemic disease or any unstable systemic disease, including but not limited to uncontrolled hypertension, uncontrolled hyperglycemia, liver and kidney insufficiency or metabolic disease, central nervous system disease, etc;
- Have any of the following heart conditions:
- New York Heart Association (NYHA) stage III or IV congestive heart failure;
- Myocardial infarction or coronary artery bypass grafting (CABG) within 6 months before enrollment;
- Clinically significant ventricular arrhythmia,
- echocardiography showed cardiac ejection fraction<50%, QTc (male)>450 ms，QTc (female)>470 ms；;
- Pregnant, lactating, or breastfeeding females;
- Patients with poor control of thoracoabdominal water;
- Other investigators deem it inappropriate to participate in the study.
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, Tianjin Municipality
Jihui Hao, 008622-23340123, haojihui@tjmuch.com
About this study
Official title: A Clinical Study of CHT102, a Universal Chimeric Antigen Receptor T-Cell Immunotherapy(U CAR-T) for Mesothelin(MSLN) Positive Advanced Solid Tumors: a Single-arm, Open-label, Dose Escalation and Expansion Clinical Study
Objectives of Study：In this study investigators plan to evaluate the safety and efficacy of MSLN-targeting Universal Chimeric Antigen Receptor T-Cell Immunotherapy(U CAR-T) in the treatment of MSLN-positive advanced solid tumors.
- Conditions
- Mesothelin Positive Tumors
- Being tested
- CHT102 allogeneic CAR T cells
- Keywords
- CHT102, a U CAR-T therapy for MSLN-positive advanced solid tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHT102 allogeneic CAR T cellsBiological
CHT102 allogeneic CAR T cells
| Study group | Role | What they receive |
|---|---|---|
| CHT102 allogeneic CAR T cells | Experimental | In the dose escalation phase of this study, one alternative dose and 4 dose groups (calculated by the number of CAR-positive T cells) were planned, each treatment lasted 28 days, and UCAR-T cells were transfused three times, respectively on D1, D5, and D9. The single dose within the group was fixed, and the dose between the groups was escalating dose. Each infusion dose was 2.5×106/kg (optional), 5×106/kg, 1×107/kg, 2×107/kg, and 3×107/kg, with a dose error of 20% allowed. Receives: Biological: CHT102 allogeneic CAR T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicities (DLTs) occurence
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Measured: Baseline up to 28 days after U CAR-T infusion
Secondary outcomes (2)
Objective Response Rate
The total response rate after 90 days of treatment with study drug.
Measured: At 4 weeks, and overall
Progression-free survival
Progression-free survival rate following drug therapy
Measured: Assessed up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start6 May 2024
- Primary completionJun 2026 (estimated)
- Study completionMay 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mesothelin Positive TumorsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT06717022
- Sponsor's protocol ID
- CHT102SIIT-01
- Status last verified
- Nov 2024
- First submitted
- 21 Nov 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No