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Advanced Solid TumorsEarly Phase 1NCT05275062

Clinical Trial to Evaluate the Safety and Efficacy of IM92 CAR-T Cells Therapy in Patients With Advanced Gastric or Pancreatic Adenocarcinoma

A Early Phase 1 study testing IM92 CAR-T cells in people with Advanced Solid Tumors and Gastric Cancer, run by Beijing Immunochina Medical Science & Technology Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a open-label, single center to determine the efficacy and safety of IM92 CAR-T cells in Patients With advanced gastric/esophagogastric combination adenocarcinoma that has failed at least second-line therapy and advanced pancreatic cancer that has failed at least first-line therapy. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
IM92 CAR-T cells
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteChina
Study dates
15 Feb 2022to 1 May 2024
Phase
Early 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, either sex;
  • Patients with pathologically diagnosed advanced gastric/ gastroesophageal junction adenocarcinoma who have failed second-line treatment at least; or patients with pathologically diagnosed advanced pancreatic cancer who have failed first-line treatment at least;
  • Tumor tissue samples were positive for CLDN18.2 IHC staining(≥+，≥10%);
  • Estimated life expectancy >12 weeks;
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
  • Women of childbearing age who had a negative blood pregnancy test before the start of the trial and agreed to take effective contraceptive measures during the trial period until the last follow-up; male subjects with fertility partners agreed to take effective contraceptive measures during the trial period until the last follow-up;
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  • Adequate organ function;
  • Adequate vascular access for leukapheresis procedure;
  • Volunteer to participate in this trial and sign on the informed consent.

Who cannot join

  • Patients have brain metastasis；
  • Patients with a history of organ transplantation or awaiting organ transplantation;
  • The side effects caused by the previous treatment of the subjects did not return to CTCAE ≤1; other tolerable events determined by investigator;
  • There is a large amount of serous effusion that cannot be controlled by treatment (such as pleural effusion, peritoneal effusion and pericardial effusion);
  • History of autoimmune disease (eg Crohn's disease, rheumatoid arthritis, systemic lupus) within the last 2 years;
  • Presence of acute or chronic graft-versus-host disease (GVHD);
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  • Use prohibited drugs or treatments within a specified period of time before cell collection；
  • History or presence of CNS disorder, such as epilepsy, epileptic seizures, cerebrovascular disease (ischemia / hemorrhage / cerebral infarction), brain edema, reversible posterior white matter encephalopathy, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, cerebral organic syndrome or mental disease;
  • Chronic or active infections requiring systemic treatment, and a history of symptomatic viral infection that has not been completely cured；
  • Live vaccine received within 6 weeks before the start of screening;
  • Cardiac dysfunction includes: long QTc syndrome or QTc interval > 480 MS; Complete left bundle branch block, grade II / III atrioventricular block; Serious and uncontrolled arrhythmias requiring drug treatment; A history of chronic congestive heart failure with NYHA ≥ 3, and the cardiac ejection fraction was less than 50% within 6 months before screening; Cardiac valvular disease with CTC AE ≥ 3; Myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, history of severe pericardial disease or other clinically significant heart diseases within 6 months before screening;
  • Patients requiring anticoagulant therapy;
  • Patients requiring continuous anti-platelet therapy;
  • History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment;
  • A history of other malignancies with a higher risk of recurrence was assessed by the investigator;
  • Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous (IV) antimicrobials for management. Simple urinary tract infection (UTI) and bacterial pharyngitis are permitted if the investigator evaluates that it can be controlled by treatment, they can be included in the group;
  • Patients at high risk of hemorrhage or perforation;
  • Patients were enrolled in another clinical study at the same time, unless it was an observational (non intervention) clinical study;
  • In the investigator's judgment, the subject is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation.

Trial locations and contacts

1 site in 1 country.

Fei Wu, MD contact

+8615801390058

wufei@immunochina.com

China1 site, 1 recruiting

  • Chinese PLA GENERAL HOSPITAL

    Beijing, Beijing Municipality

    Jianming Xu, M.D., +8613910866712, Jianmingxu2014@163.com

    Recruiting

Other trials in China

About this study

This is a open-label, single center to determine the efficacy and safety of IM92 CAR-T cells in Patients With advanced gastric/esophagogastric combination adenocarcinoma that has failed at least second-line therapy and advanced pancreatic cancer that has failed at least first-line therapy.

Being tested
IM92 CAR-T cells
Medical subject headings
Stomach Neoplasms, Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IM92 CAR-T cellsDrug

    2.5×10^8 CAR-T cells

Study groups in NCT05275062
Study groupRoleWhat they receive
IM92 CAR-T cellsExperimentalNot described
Receives: Drug: IM92 CAR-T cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse events (AEs)

    Incidence of treatment related AEs

    Measured: Up to 28 days after CAR-T cell infusion

Secondary outcomes (7)

  1. Objective response rate (ORR)

    ORR, defined as the proportion of participants with a complete response or partial response, as determined by the investigator according to RECIST v1.1

    Measured: Up to 24 weeks after CAR-T cell infusion

  2. Disease Control Rate（DCR）

    DCR,defined as the number of cases in which response are achieved from the start of cell infusion/the total number of evaluable cases (%).

    Measured: Up to 24 weeks after CAR-T cell infusion

  3. Progression-free survival (PFS)

    PFS, defined as the time from CAR-T cell infusion to the first occurrence of disease progression or death from any cause (whichever occurs first) , as determined by the investigator according to RECIST v1.1

    Measured: Up to 24 weeks after CAR-T cell infusion

  4. Overall survival (OS)

    OS , defined as the time from CAR-T cell infusion to death from any cause

    Measured: Up to 24 weeks after CAR-T cell infusion

  5. Persistence of CAR-T cells (cell counts and cell percentage in peripheral blood)

    The persistence over time of CAR T cells in the peripheral blood as determined by flow cytometry and qPCR.

    Measured: Up to 24 weeks after CAR-T cell infusion

  6. Response rate of tumor markers (CEA, CA19-9) before and after CAR-T cells infusion

    Measured: Up to 24 weeks after CAR-T cell infusion

  7. Anti-therapeutic IM92 CAR-T cells antibody

    Measured: Up to 24 weeks after IM92 CAR-T cell infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2022
  2. Study start15 Feb 2022
  3. Primary completion1 Mar 2024 (estimated)
  4. Study completion1 May 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05275062
Sponsor's protocol ID
YMCART9201
Status last verified
Feb 2022
First submitted
25 Feb 2022
Last updated
11 Mar 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing IM92 CAR-T cells in people with Advanced Solid Tumors and Gastric Cancer, run by Beijing Immunochina Medical Science & Technology Co., Ltd. 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 9 inclusion and 19 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 11 Mar 2022. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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 Fei Wu, MD (+8615801390058, wufei@immunochina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events (AEs) (time frame: Up to 28 days after CAR-T cell infusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05275062.

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 11 Mar 2022.

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