Gastric AdenocarcinomaPhase 1NCT05393986
Claudin18.2-redirected Chimeric Antigen Receptor T Cells With Co-expression of Cytokines in Solid Tumors
A Phase 1 study testing CT048 Autologous Injection (CT048) in people with Gastric Adenocarcinoma and Pancreatic Cancer, run by Peking University at 1 site in China.
Trial summary
An Open-Label, Single-Arm, Dose-Exploration Study to Evaluate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetics of CT048 in Subjects with Advanced Solid Tumors Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Adenocarcinoma, Pancreatic Cancer, Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- CT048 Autologous Injection (CT048)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteChina
- Study dates
- 4 Aug 2022to 30 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 75 years, male or female;
- Estimated life expectancy > 12 weeks;
- Pathologically/histologically confirmed diagnosis of advanced G/GEJ adenocarcinoma or pancreatic cancer or other digestive system malignancies G/GEJA: refractory to or intolerable of at least 2 prior lines of treatment; HER2+ subjects must be refractory or intolerable of anti-HER2 treatment PC: refractory to or intolerable of at least 1 prior line of treatment;
- Positive expression of CLDN18.2 in tumor tissue specimens;
- According to the RECIST 1.1, there is measurable or unmeasurable tumor lesions;
- ECOG physical status score 0 ~ 1 at screening, within 24 hours prior to apheresis;
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- Sufficient venous access for leukapheresis (central venous catheter)
- Subjects should have adequate organ functions before screening :
- Women of childbearing age (WOCB) be willing to use effective and reliable method of contraception (annual failure<1%) for at least 1 year after last infusion, and must refrain from donating sperms/eggs
- Men who have actively sexual intercourse with women with child-bearing potential, must agree to use barrier-based contraception if they have no vasectomy. Moreover, all men are absolutely forbidden to donate sperm within 1 year after receiving the last infusion.
Who cannot join
- High risks that may cause bleeding or perforation;
- CNS metastasis, with or without related symptoms;
- The presence of extensive lung metastases, or extensive liver metastases, or extensive bone metastases
- History or current unstable or active digestive ulcers, gastrointestinal (GI) bleeding, GI obstruction;
- Anti-tumor treatment for the investigational disease; treatment with anti-PD-1/PD-L1, anti-CTLA4, and any other immunotherapy or investigational therapy；
- Prior treatment with any genetically modified cell therapy;
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- Treatment with systemic corticosteroids within 7 days prior to leukapheresis;
- Prior solid organ transplantation, or allogeneic stem cell, or in the waiting list for organ transplantation;
- Major surgical procedure or serious wound within 4 weeks prior to leukapheresis, or anticipation of need for a major surgical procedure during the study;
- Positive serological tests of HIV, syphilis or HCV (subjects with positive HCV antibody but are negative for HCV RNA are eligible);
- Any active or severe infection, incl. but not limited to active tuberculosis, HBV infection, etc.;
- Active autoimmune disease;
- Uncontrolled significant cardiovascular disease, pulmonary disease or CNS disease
- History of malignancy other than investigational diseases within 3 years, with the exception of malignancies with a negligible risk of metastasis or death;
- Pregnancy or lactating women;
- History of allergic anaphylactic reactions to immunotherapy, and/or tocilizumab, cyclophosphamide, fludarabine or nab-paclitaxel, and/or CT048 components, or other history of severe allergic anaphylactic reactions ；
- Blood oxygen saturation ≤95% before leukapheresis;
- AEs from previous treatment that have not recovered to CTCAE ≤ grade 1, excluding hair loss, pigmentation, and other tolerable events and laboratory abnormalities permitted by the protocol;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital, Beijing, China
Beijing
Lin Shen, MD, 008688196561, shenlin@bjmu.edu.cn
Yanshuo Cao, MD, 008688196561, yanshuo.cao@bjmu.edu.cn
About this study
Official title: An Open-Label, Single-Arm, Dose-Exploration Study to Evaluate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetics of CT048 in Subjects With Advanced Solid Tumors
An Open-Label, Single-Arm, Dose-Exploration Study to Evaluate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetics of CT048 in Subjects with Advanced Solid Tumors
Read the detailed description
This is an open-label, single-arm, dose-escalation and dose-expansion, single/multiple infusion(s) exploratory study to evaluate the safety, tolerability, PK/PD and preliminary efficacy of CT048 in patients with advanced CLDN18.2+ solid tumors who had failed to at least 1 prior line of treatment.
- Being tested
- CT048 Autologous Injection (CT048)
- Keywords
- Claudin18.2, CAR-T cell therapy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT048 Autologous Injection (CT048)Drug
Also called CT048 Autologous CAR T-cell Injection
up to 3 times CT048 Autologous Injection infusion
| Study group | Role | What they receive |
|---|---|---|
| Experimental: CAR-CLDN18.2 T-Cells (CT048) | Experimental | The subjects will be initially enrolled in the lymphodepletion cohort. Subsequent subjects will be enrolled in the non-lymphodepletion cohort after reviewing the data in the lymphodepletion cohort. Receives: Drug: CT048 Autologous Injection (CT048) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT)
Safety
Measured: 28 days of single infusion
Maximum tolerated dose
Tolerability
Measured: 28 days of single infusion
Secondary outcomes (7)
Nature, incidence, severity and seriousness of TEAEs, TRAEs and AESI; graded according to the NCI-CTCAE (Version 5.0) or ASTCT
Adverse events occurring through 24 weeks and 12 months post CT048 indusion, such as abnormalities or changes in laboratory tests, physical examinations, vital signs, etc.
Measured: 1 year
Pharmacokinetics(the number of CAR copies and CAR persistence duration in peripheral blood)
CAR-CLDN18.2 DNA in peripheral blood detected by q-PCR at each visit after each infusion
Measured: 1 year
Antitumor efficacy-Overall response rate (ORR), Duration of response (DOR), Disease control rate (DCR)
The number of cases in which tumor size is reduced to PR or CR / the total number of evaluable cases (%). In the event of PR or CR, the subjects should confirm it no less than 6 weeks after the first evaluation
Measured: 1 year
Antitumor efficacy-Duration of response (DOR)
The period from the first evaluation of CR or PR to the first evaluation of PD or death of any cause
Measured: 1 year
Antitumor efficacy-Disease control rate (DCR)
The number of cases in which response are achieved from the start of cell infusion/the total number of evaluable cases (%).
Measured: 1 year
Antitumor efficacy-Progression-free survival
The period from the date of leukapheresis to the first recorded tumor progression or death of any cause, whichever occurs first (ITT).
Measured: 1 year
Antitumor efficacy-Overall survival (OS)
The period from the date of leukapheresis to death of any cause (ITT). The period from the date of first CT048 infusion to death of any cause (mITT).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start4 Aug 2022
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe 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
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Collaborators
- CARsgen Therapeutics Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Lin Shen, MD,phD, Principal investigator, Department of GI Oncology, Peking University Cancer Hospita
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05393986
- Sponsor's protocol ID
- CT048-CG4001
- Status last verified
- May 2023
- First submitted
- 13 May 2022
- Last updated
- 31 May 2023
- 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 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Arm, Dose-Exploration Study to Evaluate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetics of CT048 in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05393986
- Acronym / sponsor ID
- CT048-CG4001
- Keywords
- Claudin18.2, CAR-T cell therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Collaborators
- CARsgen Therapeutics Co., Ltd.
- Study start
- 4 Aug 2022 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 27 May 2022 (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.
An Open-Label, Single-Arm, Dose-Exploration Study to Evaluate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetics of CT048 in Subjects with Advanced Solid Tumors
Detailed description
This is an open-label, single-arm, dose-escalation and dose-expansion, single/multiple infusion(s) exploratory study to evaluate the safety, tolerability, PK/PD and preliminary efficacy of CT048 in patients with advanced CLDN18.2+ solid tumors who had failed to at least 1 prior line of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: CAR-CLDN18.2 T-Cells (CT048) | Experimental | Drug: CT048 Autologous Injection (CT048)The subjects will be initially enrolled in the lymphodepletion cohort. Subsequent subjects will be enrolled in the non-lymphodepletion cohort after reviewing the data in the lymphodepletion cohort. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Aged 18 to 75 years, male or female;
- Estimated life expectancy > 12 weeks;
- Pathologically/histologically confirmed diagnosis of advanced G/GEJ adenocarcinoma or pancreatic cancer or other digestive system malignancies G/GEJA: refractory to or intolerable of at least 2 prior lines of treatment; HER2+ subjects must be refractory or intolerable of anti-HER2 treatment PC: refractory to or intolerable of at least 1 prior line of treatment;
- Positive expression of CLDN18.2 in tumor tissue specimens;
- According to the RECIST 1.1, there is measurable or unmeasurable tumor lesions;
Key exclusion criteria (18 listed)
- High risks that may cause bleeding or perforation;
- CNS metastasis, with or without related symptoms;
- The presence of extensive lung metastases, or extensive liver metastases, or extensive bone metastases
- History or current unstable or active digestive ulcers, gastrointestinal (GI) bleeding, GI obstruction;
- Anti-tumor treatment for the investigational disease; treatment with anti-PD-1/PD-L1, anti-CTLA4, and any other immunotherapy or investigational therapy；
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 |
|---|---|---|
| CT048 Autologous Injection (CT048)Also: CT048 Autologous CAR T-cell Injectionup to 3 times CT048 Autologous Injection infusion | Drug | Experimental: CAR-CLDN18.2 T-Cells (CT048) |
Primary outcome
Dose-limiting toxicity (DLT)
Time frame: 28 days of single infusion
Safety
Maximum tolerated dose
Time frame: 28 days of single infusion
Tolerability
7 secondary outcomes
Nature, incidence, severity and seriousness of TEAEs, TRAEs and AESI; graded according to the NCI-CTCAE (Version 5.0) or ASTCT
Time frame: 1 year
Pharmacokinetics(the number of CAR copies and CAR persistence duration in peripheral blood)
Time frame: 1 year
Antitumor efficacy-Overall response rate (ORR), Duration of response (DOR), Disease control rate (DCR)
Time frame: 1 year
Antitumor efficacy-Duration of response (DOR)
Time frame: 1 year
Antitumor efficacy-Disease control rate (DCR)
Time frame: 1 year
Antitumor efficacy-Progression-free survival
Time frame: 1 year
Antitumor efficacy-Overall survival (OS)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- 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. This study is not recruiting at the moment.
Lin Shen, MD,phD principal investigator
Department of GI Oncology, Peking University Cancer Hospita
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 CT048 Autologous Injection (CT048) in people with Gastric Adenocarcinoma and Pancreatic Cancer, run by Peking University 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 10 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 31 May 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact lin Shen, MD,phD (861088196561, linshenpku@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (DLT) (time frame: 28 days of single infusion). The study lists 2 primary outcomes in all. 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 31 May 2023.