Relapsed Non-Hodgkin LymphomaNCT06049381
Tumor Microenvironment Mechanism of LY007 for r/r B-NHL and the Exploration of Novel CAR-T Translational Research
An observational study of Relapsed Non-Hodgkin Lymphoma, run by Ruijin Hospital.
Trial summary
The T cell characteristics of 12 patients treated with CD20 CAR-T (LY007 cell injection) were analyzed to study their relationship with CAR-T anti-tumor activity, tumor killing, and in vivo proliferation, and to explore the mechanisms: before single harvesting, before bridging, before pretreatment, D0, D7, D14, D21… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Relapsed Non-Hodgkin Lymphoma
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2023to 31 Dec 2025
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Inpatients and outpatients from Shanghai Ruijin Hospital
Who may be able to join
- 18-70 years of age (include 18 and 70);
- Eastern Cooperative Oncology Group (ECOG) score of 0-1;
- Cytologically or histologically confirmed diagnosis of CD20-positive B-NHL according to WHO 2016 criteria, including diffuse large B-cell lymphoma (including histologically transformed) and transformed follicular lymphoma (TFL);
- Relapsed or refractory B-cell non-Hodgkin's lymphoma, subjects must have been treated with at least anthracyclines and rituximab (or other CD20-targeted agents) and have relapsed, failed to remit, or progressed after at least second-line therapy or autologous hematopoietic stem cell transplantation (auto-HSCT);
Who cannot join
- Hepatitis B surface antigen (HBsAg) positive or Hepatitis B core antibody (HBcAb) positive with peripheral blood HBV DNA titer higher than the lower limit of detection; Hepatitis C virus (HCV) antibody positive with HCVRNA titer higher than the lower limit of detection; Human Immunodeficiency Virus (HIV) antibody positive; Positive syphilis serology. 2. Lymphoma involving only the central nervous system (CNS) (subjects with secondary CNS lymphoma are permitted to enroll); and
- Lymphoma involving only the central nervous system (CNS) (subjects with secondary CNS lymphoma are eligible for enrollment). 3. prior CARB vaccination prior to enrollment;
- Prior CAR-T therapy (except for prior targeted CD19 CAR-T therapy, including patients with stable disease evaluated at 3 months after CD19 CAR-T infusion or progressive disease evaluated at any time) or other genetically modified T-cell therapy prior to monotherapy.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Tumor Microenvironment Mechanism of LY007 Cell Injection for the Treatment of Relapsed and Refractory B-cell Non-Hodgkin's Lymphoma and the Exploration of Novel CAR-T Translational Research
The T cell characteristics of 12 patients treated with CD20 CAR-T (LY007 cell injection) were analyzed to study their relationship with CAR-T anti-tumor activity, tumor killing, and in vivo proliferation, and to explore the mechanisms: before single harvesting, before bridging, before pretreatment, D0, D7, D14, D21, D28, and at the time of follow-up evaluation (plus time points if taking BTKi inhibitors: Peripheral blood specimens were collected before BTKi and 48h after BTKi discontinuation, and peripheral blood cells from patients before and after treatment were analyzed by mass spectrometry flow and single-cell sequencing.
Tumor tissue specimens were collected from patients at different time points (before pretreatment, during CAR-T expansion, and at PD) and subjected to single-cell sequencing.
- Conditions
- Relapsed Non-Hodgkin Lymphoma
- Medical subject headings
- Lymphoma, Non-Hodgkin
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 |
|---|---|---|
| Patients receive LY007 CD20 CAR-T | Not described | |
| Patients receive commerial CD19 CAR-T in China | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression levels of genes (known to be possible driver genes in lymphoma) analyzed from tumor tissues collected before treatment and at the point of progression if available for DNA sequencing after quality control.
Tumor tissues collected before treatment and at the point of progression if available for DNA sequencing after quality control. On the one hand, the difference of tumor mutations will be analyzed in pre-treatment biopsy samples of patients grouped by efficacy; on the other hand, the changes of tumor mutations will be analyzed between pre-treatment and post-treatment biopsy samples of patients.
Measured: 2023.10-2025.12
Expression levels of genes (known to be possible driver genes in lymphoma) analyzed from tumor tissues collected before treatment and at the point of progression if available for RNA sequencing after quality control.
Tumor tissues collected before treatment and at the point of progression if available for bulky RNA sequencing, single-cell RNA sequencing and spatial transcriptome sequencing after quality control. On the one hand, the difference of characteristics of tumor microenvironment will be analyzed in pre-treatment biopsy samples of patients grouped by efficacy; on the other hand, the changes of characteristics of tumor microenvironment will be analyzed between pre-treatment and post-treatment biopsy samples of patients.
Measured: 2023.10-2025.12
Level of M1 macrophage in peripheral blood collected before each cycle and at the point of progression if available for Mass Cytometry.
Peripheral blood collected before each cycle and at the point of progression if available for Mass Cytometry to analyze the changes of immune celltypes and immune checkpoints.
Measured: 2023.10-2025.12
Level of M2 macrophage in peripheral blood collected before each cycle and at the point of progression if available for Mass Cytometry.
Peripheral blood collected before each cycle and at the point of progression if available for Mass Cytometry to analyze the changes of immune celltypes and immune checkpoints.
Measured: 2023.10-2025.12
Level of OX-40 in peripheral blood collected before each cycle and at the point of progression if available for Mass Cytometry.
Peripheral blood collected before each cycle and at the point of progression if available for Mass Cytometry to analyze the changes of immune celltypes and immune checkpoints.
Measured: 2023.10-2025.12
Level of PD-1 in peripheral blood collected before each cycle and at the point of progression if available for Mass Cytometry.
Peripheral blood collected before each cycle and at the point of progression if available for Mass Cytometry to analyze the changes of immune celltypes and immune checkpoints.
Measured: 2023.10-2025.12
Level of TIM-3 in peripheral blood collected before each cycle and at the point of progression if available for Mass Cytometry.
Peripheral blood collected before each cycle and at the point of progression if available for Mass Cytometry to analyze the changes of immune celltypes and immune checkpoints.
Measured: 2023.10-2025.12
Level of LAG-3 in peripheral blood collected before each cycle and at the point of progression if available for Mass Cytometry.
Peripheral blood collected before each cycle and at the point of progression if available for Mass Cytometry to analyze the changes of immune celltypes and immune checkpoints.
Measured: 2023.10-2025.12
Level of lymphocyte subpopulations in peripheral blood collected before each cycle and at the point of progression if available for Mass Cytometry.
Peripheral blood collected before each cycle and at the point of progression if available for Mass Cytometry to analyze the changes of immune celltypes and immune checkpoints.
Measured: 2023.10-2025.12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start1 Oct 2023 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed Non-Hodgkin 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 22 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
- NCT06049381
- Sponsor's protocol ID
- LYCAR-01
- Status last verified
- Sep 2023
- First submitted
- 28 Aug 2023
- Last updated
- 22 Sep 2023
- Results posted
- 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 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tumor Microenvironment Mechanism of LY007 Cell Injection for the Treatment of Relapsed and Refractory B-cell Non-Hodgkin's Lymphoma and the Exploration of Novel CAR-T Translational Research
- ClinicalTrials.gov ID
- NCT06049381
- Acronym / sponsor ID
- LYCAR-01
- Conditions
- Relapsed Non-Hodgkin Lymphoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 Sep 2023 (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.
The T cell characteristics of 12 patients treated with CD20 CAR-T (LY007 cell injection) were analyzed to study their relationship with CAR-T anti-tumor activity, tumor killing, and in vivo proliferation, and to explore the mechanisms: before single harvesting, before bridging, before pretreatment, D0, D7, D14, D21, D28, and at the time of follow-up evaluation (plus time points if taking BTKi inhibitors: Peripheral blood specimens were collected before BTKi and 48h after BTKi discontinuation, and peripheral blood cells from patients before and after treatment were analyzed by mass spectrometry flow and single-cell sequencing.
Tumor tissue specimens were collected from patients at different time points (before pretreatment, during CAR-T expansion, and at PD) and subjected to single-cell sequencing.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients receive LY007 CD20 CAR-T | – | – |
| Patients receive commerial CD19 CAR-T in China | – | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inpatients and outpatients from Shanghai Ruijin Hospital
Key inclusion criteria (4 listed)
- 18-70 years of age (include 18 and 70);
- Eastern Cooperative Oncology Group (ECOG) score of 0-1;
- Cytologically or histologically confirmed diagnosis of CD20-positive B-NHL according to WHO 2016 criteria, including diffuse large B-cell lymphoma (including histologically transformed) and transformed follicular lymphoma (TFL);
- Relapsed or refractory B-cell non-Hodgkin's lymphoma, subjects must have been treated with at least anthracyclines and rituximab (or other CD20-targeted agents) and have relapsed, failed to remit, or progressed after at least second-line therapy or autologous hematopoietic stem cell transplantation (auto-HSCT);
Key exclusion criteria (3 listed)
- Hepatitis B surface antigen (HBsAg) positive or Hepatitis B core antibody (HBcAb) positive with peripheral blood HBV DNA titer higher than the lower limit of detection; Hepatitis C virus (HCV) antibody positive with HCVRNA titer higher than the lower limit of detection; Human Immunodeficiency Virus (HIV) antibody positive; Positive syphilis serology. 2. Lymphoma involving only the central nervous system (CNS) (subjects with secondary CNS lymphoma are permitted to enroll); and
- Lymphoma involving only the central nervous system (CNS) (subjects with secondary CNS lymphoma are eligible for enrollment). 3. prior CARB vaccination prior to enrollment;
- Prior CAR-T therapy (except for prior targeted CD19 CAR-T therapy, including patients with stable disease evaluated at 3 months after CD19 CAR-T infusion or progressive disease evaluated at any time) or other genetically modified T-cell therapy prior to monotherapy.
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
Expression levels of genes (known to be possible driver genes in lymphoma) analyzed from tumor tissues collected before treatment and at the point of progression if available for DNA sequencing after quality control.
Time frame: 2023.10-2025.12
Tumor tissues collected before treatment and at the point of progression if available for DNA sequencing after quality control. On the one hand, the difference of tumor mutations will be analyzed in pre-treatment biopsy samples of patients grouped by efficacy; on the other hand, the changes of tumor mutations will be analyzed between pre-treatment and post-treatment biopsy samples of patients.
Expression levels of genes (known to be possible driver genes in lymphoma) analyzed from tumor tissues collected before treatment and at the point of progression if available for RNA sequencing after quality control.
Time frame: 2023.10-2025.12
Tumor tissues collected before treatment and at the point of progression if available for bulky RNA sequencing, single-cell RNA sequencing and spatial transcriptome sequencing after quality control. On the one hand, the difference of characteristics of tumor microenvironment will be analyzed in pre-treatment biopsy samples of patients grouped by efficacy; on the other hand, the changes of characteristics of tumor microenvironment will be analyzed between pre-treatment and post-treatment biopsy samples of patients.
Level of M1 macrophage in peripheral blood collected before each cycle and at the point of progression if available for Mass Cytometry.
Time frame: 2023.10-2025.12
Peripheral blood collected before each cycle and at the point of progression if available for Mass Cytometry to analyze the changes of immune celltypes and immune checkpoints.
Level of M2 macrophage in peripheral blood collected before each cycle and at the point of progression if available for Mass Cytometry.
Time frame: 2023.10-2025.12
Peripheral blood collected before each cycle and at the point of progression if available for Mass Cytometry to analyze the changes of immune celltypes and immune checkpoints.
Level of OX-40 in peripheral blood collected before each cycle and at the point of progression if available for Mass Cytometry.
Time frame: 2023.10-2025.12
Peripheral blood collected before each cycle and at the point of progression if available for Mass Cytometry to analyze the changes of immune celltypes and immune checkpoints.
Level of PD-1 in peripheral blood collected before each cycle and at the point of progression if available for Mass Cytometry.
Time frame: 2023.10-2025.12
Peripheral blood collected before each cycle and at the point of progression if available for Mass Cytometry to analyze the changes of immune celltypes and immune checkpoints.
Level of TIM-3 in peripheral blood collected before each cycle and at the point of progression if available for Mass Cytometry.
Time frame: 2023.10-2025.12
Peripheral blood collected before each cycle and at the point of progression if available for Mass Cytometry to analyze the changes of immune celltypes and immune checkpoints.
Level of LAG-3 in peripheral blood collected before each cycle and at the point of progression if available for Mass Cytometry.
Time frame: 2023.10-2025.12
Peripheral blood collected before each cycle and at the point of progression if available for Mass Cytometry to analyze the changes of immune celltypes and immune checkpoints.
Level of lymphocyte subpopulations in peripheral blood collected before each cycle and at the point of progression if available for Mass Cytometry.
Time frame: 2023.10-2025.12
Peripheral blood collected before each cycle and at the point of progression if available for Mass Cytometry to analyze the changes of immune celltypes and immune checkpoints.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsed Non-Hodgkin Lymphoma, run by Ruijin Hospital.
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 4 inclusion and 3 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 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Zixun Yan, Doctor (+862164370045 ext. 610707, yzx12119@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression levels of genes (known to be possible driver genes in lymphoma) analyzed from tumor tissues collected before treatment and at the point of progression if available for DNA sequencing after quality control. (time frame: 2023.10-2025.12). The study lists 9 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 22 Sep 2023.