Diffuse Large B Cell LymphomaNCT05189782
Mechanism of Resistance to GNC-038 in Relapsed and Refractory Diffuse Large B-cell Lymphoma
An observational study of Diffuse Large B Cell Lymphoma, run by Ruijin Hospital at 1 site in China.
Trial summary
This is an exploratory study embedded in the Phase Ib/II clinical trial of CD3 x 4-1BB x CD19 x PD-L1 tetra-specific T cell engager GNC-038 in relapsed and refractory diffuse large B-cell lymphoma initiated by the corresponding pharmaceutical company. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diffuse Large B Cell Lymphoma
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2022to 1 Sep 2024
- Phase
- Observational
- 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 80 years
- All sexes
- Adult, Older adult
Study population: This study plans to include 10 subjects enrolled in the GNC-038 Phase Ib/II clinical trial in Ruijin Hospital. It also plans to include five patients who have tonsillectomy in Ruijin Hosptial due to obstructive sleep apnea and hyponea syndrome as the control group.
Who may be able to join
- For Group 1, the selection criteria are firstly concordant with those of the corresponding clinical trial. On this basis, additional selection criteria for this study are:
- Lymph node lesions with long diameter ≥ 2cm.
- Subjects have the ability and willingness to follow the visit, biosample collection and other research-related processes prescribed by the research program and to sign informed consent forms.
- For Group 2, the selection criteria are:
- The subject is able to understand the informed consent form, and voluntarily participates and signs the informed consent form;
- Age between 18 and 80;
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 points.
Who cannot join
- For Group 1, the exclusion criteria are totally concordant with those of the corresponding clinical trial. There is no additional exclusion criteria for this study.
- For Group 2, the exclusion criteria are:
- History of past or present malignant diseases;
- Patients with active autoimmune diseases, or patients with a history of autoimmune diseases, including but not limited to Crohn's disease, ulcerative colitis, systemic lupus erythematosus, sarcoidosis, Wegener's granulomatosis, polyvascular inflammation granuloma, Grave's disease, rheumatoid arthritis, pituitary inflammation, ophthalmic pigmentitis, autoimmune hepatitis, systemic sclerosis, Hashimoto thyroiditis, autoimmune vasculitis, autoimmune neuropathy (Guillain- Barre syndrome), etc.;
- Human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis B virus infection (HBsAg-positive or HBcAb-positive, HBV-DNA test positive), hepatitis C virus infection (HCV antibody-positive and HCV-RNA test positive), EB virus infection (EBV-DNA test positive), cytomegalovirus infection (CMV-DNA test positive) or herpes simplex virus infection (HSV-DNA test positive);
- Pregnant or nursing women;
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- Previous organ transplants or allogeneic hematopoietic stem cell transplants;
- Under treatment of immunosuppressants, including but not limited to cyclosporine, tacrolimus, corticosteroids, etc., within 1 month prior to sampling;
- Fever (temperature >37.5 ℃) within 1 month prior to sampling, or using antibiotics due to respiratory, gastrointestinal, urinary tract infections, etc.;
- Other situations in which the researchers consider it inappropriate for the patient to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Weili Zhao, M.D. and Ph.D, 13512112076, zhao.weili@yahoo.com
About this study
Official title: Mechanism of Resistance to GNC-038, a Tetra-specific T Cell Engager, in Relapsed and Refractory Diffuse Large B-cell Lymphoma
This is an exploratory study embedded in the Phase Ib/II clinical trial of CD3 x 4-1BB x CD19 x PD-L1 tetra-specific T cell engager GNC-038 in relapsed and refractory diffuse large B-cell lymphoma initiated by the corresponding pharmaceutical company. By measuring immune cell components and their functional phenotypes in peripheral blood and tumor tissues before and after the subject's medication, this study aims to identify key immune cell populations and immune molecules which play an important role in resistance to GNC-038 treatment, so as to optimize drug design and develop combination therapies to improve treatment efficacy.
- Conditions
- Diffuse Large B Cell Lymphoma
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Subjects of the GNC-038 clinical trial (1) | Patients enrolled in the GNC-038 Phase Ib/II clinical trial in Shanghai Ruijin Hospital. | |
| Non-malignant controls (2) | Patients who have tonsillectomy due to obstructive sleep apnea and hyponea syndrome. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The abundance and phenotypes of immune cell subtypes within tumor or normal tonsil tissues measured by single-cell RNA sequencing.
Core needle biopsies of lymph node lesions (in Group 1) or resected normal tonsil tissues (in Group 2) will be collected. 5' end single-cell RNA sequencing plus single-cell T cell receptor sequencing will be performed. The abundance and phenotypes of immune cell subtypes will be investigated using the above data.
Measured: In Group 1: change from screening to six weeks after treatment initiation, and to disease relapse or progression assessed up to 6 months after last treatment. In Group 2: immediately following tonsil resection.
The abundance and phenotypes of peripheral blood T cell subtypes measured by mass cytometry by the time-of-flight.
Peripheral blood mononuclear cells will be collected and mass cytometry by the time-of-flight will be performed to analyze a panel of T cell subtyping and functional surface molecules.
Measured: In Group 1: change from screening to day 22 and day 43 after treatment initiation, to 30 days after treatment ending, and to disease relapse or progression assessed up to 6 months after last treatment. In Group 2: within a week before tonsil resection.
Secondary outcomes (2)
Tumor cytogenetic and molecular genetic abnormalities.
In Group 1, core needle biopsies of lymph node lesions will be collected, and whole exome sequencing will be performed to detect tumor cytogenetic and molecular genetic abnormalities. Peripheral blood mononuclear cells will also be collected and sequenced as healthy tissue reference.
Measured: During screening, six weeks after treatment initiation, and at disease relapse or progression assessed up to 6 months after last treatment.
Tumor gene expression profiles.
In Group 1, core needle biopsies of lymph node lesions will be collected, and bulk RNA sequencing will be performed to analyze gene expression profiles of tumors.
Measured: In Group 1: during screening, six weeks after treatment initiation, and at disease relapse or progression assessed up to 6 months after last treatment. In Group 2: immediately following tonsil resection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start10 Aug 2022
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Ruijin 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Weili, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05189782
- Sponsor's protocol ID
- TRANS001-TeTE
- Status last verified
- Aug 2022
- First submitted
- 3 Sep 2021
- Last updated
- 31 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanism of Resistance to GNC-038, a Tetra-specific T Cell Engager, in Relapsed and Refractory Diffuse Large B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT05189782
- Acronym / sponsor ID
- TRANS001-TeTE
- Conditions
- Diffuse Large B Cell Lymphoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 10 Aug 2022 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 13 Jan 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.
This is an exploratory study embedded in the Phase Ib/II clinical trial of CD3 x 4-1BB x CD19 x PD-L1 tetra-specific T cell engager GNC-038 in relapsed and refractory diffuse large B-cell lymphoma initiated by the corresponding pharmaceutical company. By measuring immune cell components and their functional phenotypes in peripheral blood and tumor tissues before and after the subject's medication, this study aims to identify key immune cell populations and immune molecules which play an important role in resistance to GNC-038 treatment, so as to optimize drug design and develop combination therapies to improve treatment efficacy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects of the GNC-038 clinical trial (1) | – | –Patients enrolled in the GNC-038 Phase Ib/II clinical trial in Shanghai Ruijin Hospital. |
| Non-malignant controls (2) | – | –Patients who have tonsillectomy due to obstructive sleep apnea and hyponea syndrome. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This study plans to include 10 subjects enrolled in the GNC-038 Phase Ib/II clinical trial in Ruijin Hospital. It also plans to include five patients who have tonsillectomy in Ruijin Hosptial due to obstructive sleep apnea and hyponea syndrome as the control group.
Key inclusion criteria (7 listed)
- For Group 1, the selection criteria are firstly concordant with those of the corresponding clinical trial. On this basis, additional selection criteria for this study are:
- Lymph node lesions with long diameter ≥ 2cm.
- Subjects have the ability and willingness to follow the visit, biosample collection and other research-related processes prescribed by the research program and to sign informed consent forms.
- The subject is able to understand the informed consent form, and voluntarily participates and signs the informed consent form;
- Age between 18 and 80;
Key exclusion criteria (10 listed)
- For Group 1, the exclusion criteria are totally concordant with those of the corresponding clinical trial. There is no additional exclusion criteria for this study.
- History of past or present malignant diseases;
- Patients with active autoimmune diseases, or patients with a history of autoimmune diseases, including but not limited to Crohn's disease, ulcerative colitis, systemic lupus erythematosus, sarcoidosis, Wegener's granulomatosis, polyvascular inflammation granuloma, Grave's disease, rheumatoid arthritis, pituitary inflammation, ophthalmic pigmentitis, autoimmune hepatitis, systemic sclerosis, Hashimoto thyroiditis, autoimmune vasculitis, autoimmune neuropathy (Guillain- Barre syndrome), etc.;
- Human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis B virus infection (HBsAg-positive or HBcAb-positive, HBV-DNA test positive), hepatitis C virus infection (HCV antibody-positive and HCV-RNA test positive), EB virus infection (EBV-DNA test positive), cytomegalovirus infection (CMV-DNA test positive) or herpes simplex virus infection (HSV-DNA test positive);
- Pregnant or nursing women;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The abundance and phenotypes of immune cell subtypes within tumor or normal tonsil tissues measured by single-cell RNA sequencing.
Time frame: In Group 1: change from screening to six weeks after treatment initiation, and to disease relapse or progression assessed up to 6 months after last treatment. In Group 2: immediately following tonsil resection.
Core needle biopsies of lymph node lesions (in Group 1) or resected normal tonsil tissues (in Group 2) will be collected. 5' end single-cell RNA sequencing plus single-cell T cell receptor sequencing will be performed. The abundance and phenotypes of immune cell subtypes will be investigated using the above data.
The abundance and phenotypes of peripheral blood T cell subtypes measured by mass cytometry by the time-of-flight.
Time frame: In Group 1: change from screening to day 22 and day 43 after treatment initiation, to 30 days after treatment ending, and to disease relapse or progression assessed up to 6 months after last treatment. In Group 2: within a week before tonsil resection.
Peripheral blood mononuclear cells will be collected and mass cytometry by the time-of-flight will be performed to analyze a panel of T cell subtyping and functional surface molecules.
2 secondary outcomes
Tumor cytogenetic and molecular genetic abnormalities.
Time frame: During screening, six weeks after treatment initiation, and at disease relapse or progression assessed up to 6 months after last treatment.
Tumor gene expression profiles.
Time frame: In Group 1: during screening, six weeks after treatment initiation, and at disease relapse or progression assessed up to 6 months after last treatment. In Group 2: immediately following tonsil resection.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diffuse Large B Cell Lymphoma, run by Ruijin 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 7 inclusion and 10 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 Aug 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.
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 Weili Zhao, M.D. and Ph.D (13512112076, zhao.weili@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The abundance and phenotypes of immune cell subtypes within tumor or normal tonsil tissues measured by single-cell RNA sequencing. (time frame: In Group 1: change from screening to six weeks after treatment initiation, and to disease relapse or progression assessed up to 6 months after last treatment. In Group 2: immediately following tonsil resection.). 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 Aug 2022.