B-NHLPhase 1r/r B-NHLNCT06279611
An Evaluation of LY007 Cell Injection for r/r B-NHL
A Phase 1 study testing LY007 in people with B-NHL, run by Shanghai Longyao Biotechnology Inc., Ltd. at 1 site in China.
Trial summary
An evaluation of LY007 cell injection for recurrent/refractory CD20 was positive Tolerability, safety, and efficacy of B-cell non-Hodgkin lymphoma in open, single-arm Phsea I Clinical research Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- B-NHL
- What is being tested?
- LY007
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 25 Dec 2021to 31 May 2026
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must meet all of the following inclusion criteria to be enrolled in the study:
- Age 18-70 years old (including 18 years old and 70 years old), regardless of gender;
- Can understand the study and have signed the informed consent;
- Expected survival time \> 3 months;
- The American Eastern Oncology Consortium (ECOG) score was 0-1;
- Cd20-positive B-NHL was confirmed cytologically or histologically according to WHO 2016 criteria These include diffuse large B-cell lymphomas (including histologically transformed forms) and transformed follicular lymphomas (TFL); (For the expression status of CD20, the histological diagnosis of CD20 has been clearly documented in the past Positive subjects (diagnosis within 3 months prior to screening); Subjects without prior records, Pathological specimens provided or collected by our hospital were diagnosed as CD20 positive; Not without a clear record For those who provide or collect specimens, the researchers and sponsors will decide whether to be included according to their medical records);
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- For recurrent or refractory B-cell non-Hodgkin lymphoma, subjects must have at least been treated with anthracene Treatment with cyclodrugs and rituximab (or other CD20-targeting drugs), and have already received them At least two cycles of treatment; Refractory is defined as the best response to the most recent treatment regimen as disease progression, or the last treatment The optimal response of the regimen (at least 2 cycles) was stable disease with a duration of less than 6 months.
- Does not meet the criteria for autologous hematopoietic stem cell transplantation (auto-HSCT) or is unwilling to perform autologous transplantation Patients with recurrence or progression after blood stem cell transplantation or autologous hematopoietic stem cell transplantation;
- The venous access required for mononuclear cell collection can be established, and the hemoglobin is ≥70 g/L and neutral Granulocyte ≥ 1.0×109/L, platelet ≥50×109/L, a single nucleus can be performed by the investigator's judgment Cell collection;
- Evaluable lesions identified according to the 2014 Lugano efficacy evaluation criteria;
- Organ functions meet the following requirements:
- The investigator assessed sufficient bone marrow function to receive lymphocyte clearance chemotherapy;
- Serum creatinine ≤1.5× upper limit of normal (ULN) or creatinine clearance (Cockcroft and Gault) > 30 mL/min/1.73 m2;
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3× ULN (ALT and AST in patients with liver metastasis ≤5×ULN);
- Total bilirubin ≤2.0 × ULN (for patients with Gilbert's syndrome or lymphoma invading the liver≤3 × ULN);
- Lung function: ≤CTCAE grade 1 dyspnea and oxygen saturation of basic finger pulse in indoor air environment Sum degree ≥92%;
- Cardiac function: Normal diastolic function, echocardiography or radiation within 1 month prior to enrollment Sexual nuclide active angiography (MUGA) revealed left ventricular ejection fraction (LVEF) ≥ 50%, no clinically significant pericardial effusion. Exclusion criteria Subjects who meet any of the following criteria will not be enrolled in this study
Who cannot join
- Subjects who meet any of the following criteria are excluded from the study:
- Fully treated cervical carcinoma in situ and a history of other malignant tumors within 5 years prior to screening Adeno-papillary carcinoma, basal cell or squamous cell skin cancer, local front line after radical surgery Except adenocarcinoma and ductal carcinoma in situ after radical surgery;
- Hepatitis B surface antigen (HBsAg) positive, or Hepatitis B core antibody (HBcAb) positive and peripheral The blood HBV DNA titer was higher than the lower limit. Hepatitis C virus (HCV) antibody positive and HCV RNA titer was higher than the lower limit of detection. Positive for human immunodeficiency virus (HIV) antibodies; Serological test positive for syphilis;
- Any of the following unstable diseases (including but not limited to) have occurred in the 6 months prior to screening Stable angina pectoris; Cerebral ischemia or cerebral vascular accident; Myocardial infarction; Congestive heart failure (New York Heart Association [NYHA] classification ≥III); Severe cardiac arrhythmia requiring medical treatment Often; After heart angioplasty or coronary stent implantation or heart bypass surgery; mining History of deep vein thrombosis or pulmonary embolism within 6 months prior to cell collection;
- Lymphoma involving the central nervous system (CNS) only (subjects with secondary CNS lymphoma) Allow to be included);
- Previous or clinically significant central nervous system history or disease at the time of screening, such as epilepsy, epilepsy Seizures, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, Organic syndrome or mental illness;
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- Active autoimmune disease (including but not limited to systemic lupus erythematosus, dry disease) within 2 years Dryness syndrome, rheumatoid arthritis, psoriasis, multiple sclerosis, inflammatory bowel disease, Hashimoto Thyroiditis, etc., except for hypothyroidism that can only be controlled by hormone replacement therapy);
- Active or uncontrolled infection requiring systemic treatment within 14 days prior to apheresis;
- There are active tuberculosis patients in the screening period;
- During the screening period, there are lymphoma lesions in the lung or gastrointestinal tract that are considered by investigators to be at risk of bleeding Of patients;
- Was receiving systemic steroid therapy prior to screening and was determined by the investigator to be prolonged during the study period Subjects treated with systemic steroids; Systemic treatment was used within 72 hours before cell transfusion Alcohol-treated subjects (except for inhalation or topical use);
- Pre-amperectomy CAR-T therapy (except previous CD19-targeted CAR-T therapy) Efficacy was evaluated as disease stable or at any time at 3 months after CD19 CAR-T reinfusion Efficacy evaluation for patients with disease progression) or other genetically modified T cell therapy;
- Received autologous stem cell transplantation within 6 weeks before anapheresis;
- Presence of grade ≥2 acute graft-versus-host disease (GVHD) requiring treatment within 4 weeks prior to anaphermology (Glucksberg standard) or generalized chronic GVHD (Seattle Standard) or by researchers Who may need anti-GVHD therapy during the trial;
- Treatment with alenzumab 6 months before monocyst, or fludarabine or Fludarabine within 3 months before monocyst Cladobine treatment;
- Received non-lymphocytotoxic cytotoxic chemotherapeutic drugs within 1 week before anapheresis. If it's a single harvest If the former oral chemotherapy drug has passed at least 3 half-lives, it is allowed to be included in the group.
- Received lymphocytotoxic chemotherapy (e.g. Cyclophosphamide, IFosfamide, benzene) within 2 weeks of preharvest Damustine);
- Use of other study drugs within 4 weeks prior to anapheresis. But ineffective or disease progression during the trial, and If at least 3 half-lives had passed before the single harvest, they were allowed to be included.
- LY007 cell injection received donor lymphocyte infusion (DLI) within 6 weeks prior to administration;
- Received radiotherapy within 6 weeks prior to anapheresis. Disease progression at the subject's radiotherapy site, or other unirradiated areas Only patients with PET positive lesions were eligible for inclusion. If PET is present in other unirradiated sites For positive lesions, radiotherapy for a single lesion was allowed 2 weeks before anapheresis.
- Acute side effects caused by previous treatment did not recover to grade 1 or below (hematological toxicity and alopecia) Except);
- The presence of life-threatening hypersensitivity or other intolerance to the drugs used in the study Severe allergies;
- Any of the following:
- Platelet transfusion within 1 week before enrollment;
- Red blood cell (RBC) transfusion within 2 weeks prior to enrollment;
- Granulocyte macrophage colony-stimulating factor (GM-CSF) was administered during the first 2 weeks of enrollment.
- Persons who are pregnant or breastfeeding, or who plan to become pregnant within 1 year after cell transfusion, or partners in their cell cycle Male subjects planning pregnancy within 1 year after transfusion;
- Any situation that the investigator believes will compromise the safety of the subject or interfere with the purpose of the study or cannot be complied with Adhere to the study protocol or other circumstances that are not suitable for inclusion
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ruijin hospital
Shanghai, Shanghai Municipality
zhao weili, MD, 13512112076 ext. 610707, zwl_trial@163.com
yan zixun, MD, +8613482056727 ext. 610707, yanzixun125@163.com
About this study
Official title: An Evaluation of LY007 Cell Injection for Recurrent/Refractory CD20 Was Positive Tolerability, Safety, and Efficacy of B-cell Non-Hodgkin Lymphoma in Open, Single-arm Stage I Clinical Research
An evaluation of LY007 cell injection for recurrent/refractory CD20 was positive Tolerability, safety, and efficacy of B-cell non-Hodgkin lymphoma in open, single-arm Phsea I Clinical research
Read the detailed description
This is a phase I single-arm, open, "3+3" dose escalation study to evaluate the efficacy of LY007 cell injection Safety, tolerability, PK characteristics, PD characteristics, initial efficacy and immunogenicity.
This study plans to enroll approximately 9-18 subjects with relapsed/refractory CD20-positive B-NHL, including DLBCL (inclusive Histological transformation) and TFL. The number of subjects ultimately enrolled depends on the number of DLT observed during the dose escalation phase The number of incremental dose groups prior to DLT and the determination of MTD or clinically recommended dose.
- Conditions
- B-NHL
- Being tested
- LY007
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY007Drug
FC and LY007 infusion
| Study group | Role | What they receive |
|---|---|---|
| LY007 | Experimental | The CAR T cell preparation to be evaluated in this study is LY007, developed and produced by Shanghai Longyao Biotechnology Co., LTD Cell injection. LY007 cell injection is a chimeric antigen receptor targeting CD20 genetically modified using lentiviral vectors (CAR) Autologous T cells are CD20 CAR-T independently developed by Shanghai Longyao Biotechnology Co., LTD., in the CAR facility The independent co-stimulatory signal receptor OX40 was introduced to increase the proliferation and killing function of CAR-T cells. Table of CAR gene The frame comprises the following elements: (1) MSCVEF1α fusion promoter; (2) Single-chain antibody CD20 scFv targeting CD20; (3) CD8 junction and transmembrane region; (4) Intracellular region of 4-1BB; (5) CD3ζ intracellular region; (6) P2A self-shearing peptide; (7) Co-stimulated receptor OX40 Receives: Drug: LY007 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose or clinically recommended dose
No more than 1 out of 6 subjects experienced the highest dose of DLT. At least 6 subjects need to be evaluated at the MTD dose.
Measured: Day0 to 2year
Dose limiting toxicity
Adverse events (AEs) that meet the following criteria and occur within 28 days after the subject receives LY007 cell injection reinfusion will be classified using the ASTCT 2018 standard for CRS and neurotoxicity, while the remaining AEs will be evaluated using the CTCAE 5.0 standard:
- Any grade 4 or 5 AE related to LY007 cell injection after treatment, excluding no clinically significant laboratory test indicators;
- Any grade 3 AE related to LY007 cell injection that does not improve to ≤ grade 2 within 7 days after treatment, excluding laboratory test indicators with no clinical significance;
- Any grade 3 seizures that occur after treatment and cannot be relieved to ≤ grade 2 within 3 days;
- Any ≥ level 3 autoimmune toxicity (excluding B cell dysgenesis) that occurs after treatment.
Measured: Day0 to 2year
Adverse Events , Serious Adverse Events , Adverse Events of Particular Concern
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0".
Measured: Day0 to 2year
Secondary outcomes (6)
PK aspect
Number of LY007 cells in peripheral blood after LY007 cell administration.
Measured: Day0 to 2year
PK aspect
copy number of CAR gene in peripheral blood after LY007 cell administration.
Measured: Day0 to 2year
PD aspect
The proportion of lymphocyte subtypes in peripheral blood before and after administration of LY007 cell injection;
Measured: Day0 to 2year
therapeutic effect
Objective response rate (ORR) evaluated according to Lugano 2014 criteria (at least 3 after cell transfusion)
Measured: Day0 to 2year
Anti LY007 antibody
The production of anti LY007 antibody (ADA) in serum
Measured: Day0 to 2year
The titer of human anti mouse antibody
the titer of human anti mouse antibody (HAMA) in serum
Measured: Day0 to 2year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start25 Dec 2021
- Primary completion31 Aug 2024 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-NHLStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Longyao Biotechnology Inc., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhao Weili, MD, Principal investigator, Ruijin Hospital, Shanghai Jiaotong University School of Medicine Recruiting Shanghai, Shanghai, China, 200025
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06279611
- Sponsor's protocol ID
- LY007C1101
- Acronym
- r/r B-NHL
- Status last verified
- Feb 2024
- First submitted
- 2 Feb 2024
- Last updated
- 28 Feb 2024
- 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 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of LY007 Cell Injection for Recurrent/Refractory CD20 Was Positive Tolerability, Safety, and Efficacy of B-cell Non-Hodgkin Lymphoma in Open, Single-arm Stage I Clinical Research
- ClinicalTrials.gov ID
- NCT06279611
- Acronym / sponsor ID
- r/r B-NHL / LY007C1101
- Conditions
- B-NHL
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Shanghai Longyao Biotechnology Inc., Ltd.University, hospital or other
- Collaborators
- The First Affiliated Hospital with Nanjing Medical University, Ruijin Hospital
- Study start
- 25 Dec 2021 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 28 Feb 2024 (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 evaluation of LY007 cell injection for recurrent/refractory CD20 was positive Tolerability, safety, and efficacy of B-cell non-Hodgkin lymphoma in open, single-arm Phsea I Clinical research
Detailed description
This is a phase I single-arm, open, "3+3" dose escalation study to evaluate the efficacy of LY007 cell injection Safety, tolerability, PK characteristics, PD characteristics, initial efficacy and immunogenicity.
This study plans to enroll approximately 9-18 subjects with relapsed/refractory CD20-positive B-NHL, including DLBCL (inclusive Histological transformation) and TFL. The number of subjects ultimately enrolled depends on the number of DLT observed during the dose escalation phase The number of incremental dose groups prior to DLT and the determination of MTD or clinically recommended dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LY007 | Experimental | Drug: LY007The CAR T cell preparation to be evaluated in this study is LY007, developed and produced by Shanghai Longyao Biotechnology Co., LTD Cell injection. LY007 cell injection is a chimeric antigen receptor targeting CD20 genetically modified using lentiviral vectors (CAR) Autologous T cells are CD20 CAR-T independently developed by Shanghai Longyao Biotechnology Co., LTD., in the CAR facility The independent co-stimulatory signal receptor OX40 was introduced to increase the proliferation and killing function of CAR-T cells. Table of CAR gene The frame comprises the following elements: (1) MSCVEF1α fusion promoter; (2) Single-chain antibody CD20 scFv targeting CD20; (3) CD8 junction and transmembrane region; (4) Intracellular region of 4-1BB; (5) CD3ζ intracellular region; (6) P2A self-shearing peptide; (7) Co-stimulated receptor OX40 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Participants must meet all of the following inclusion criteria to be enrolled in the study:
- Age 18-70 years old (including 18 years old and 70 years old), regardless of gender;
- Can understand the study and have signed the informed consent;
- Expected survival time \> 3 months;
- The American Eastern Oncology Consortium (ECOG) score was 0-1;
Key exclusion criteria (28 listed)
- Fully treated cervical carcinoma in situ and a history of other malignant tumors within 5 years prior to screening Adeno-papillary carcinoma, basal cell or squamous cell skin cancer, local front line after radical surgery Except adenocarcinoma and ductal carcinoma in situ after radical surgery;
- Hepatitis B surface antigen (HBsAg) positive, or Hepatitis B core antibody (HBcAb) positive and peripheral The blood HBV DNA titer was higher than the lower limit. Hepatitis C virus (HCV) antibody positive and HCV RNA titer was higher than the lower limit of detection. Positive for human immunodeficiency virus (HIV) antibodies; Serological test positive for syphilis;
- Any of the following unstable diseases (including but not limited to) have occurred in the 6 months prior to screening Stable angina pectoris; Cerebral ischemia or cerebral vascular accident; Myocardial infarction; Congestive heart failure (New York Heart Association [NYHA] classification ≥III); Severe cardiac arrhythmia requiring medical treatment Often; After heart angioplasty or coronary stent implantation or heart bypass surgery; mining History of deep vein thrombosis or pulmonary embolism within 6 months prior to cell collection;
- Lymphoma involving the central nervous system (CNS) only (subjects with secondary CNS lymphoma) Allow to be included);
- Previous or clinically significant central nervous system history or disease at the time of screening, such as epilepsy, epilepsy Seizures, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, Organic syndrome or mental illness;
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 |
|---|---|---|
| LY007FC and LY007 infusion | Drug | LY007 |
Primary outcome
Maximum tolerated dose or clinically recommended dose
Time frame: Day0 to 2year
No more than 1 out of 6 subjects experienced the highest dose of DLT. At least 6 subjects need to be evaluated at the MTD dose.
Dose limiting toxicity
Time frame: Day0 to 2year
Adverse events (AEs) that meet the following criteria and occur within 28 days after the subject receives LY007 cell injection reinfusion will be classified using the ASTCT 2018 standard for CRS and neurotoxicity, while the remaining AEs will be evaluated using the CTCAE 5.0 standard: 1. Any grade 4 or 5 AE related to LY007 cell injection after treatment, excluding no clinically significant laboratory test indicators; 2. Any grade 3 AE related to LY007 cell injection that does not improve to ≤ grade 2 within 7 days after treatment, excluding laboratory test indicators with no clinical significance; 3. Any grade 3 seizures that occur after treatment and cannot be relieved to ≤ grade 2 within 3 days; 4. Any ≥ level 3 autoimmune toxicity (excluding B cell dysgenesis) that occurs after treatment.
Adverse Events , Serious Adverse Events , Adverse Events of Particular Concern
Time frame: Day0 to 2year
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0".
6 secondary outcomes
PK aspect
Time frame: Day0 to 2year
PK aspect
Time frame: Day0 to 2year
PD aspect
Time frame: Day0 to 2year
therapeutic effect
Time frame: Day0 to 2year
Anti LY007 antibody
Time frame: Day0 to 2year
The titer of human anti mouse antibody
Time frame: Day0 to 2year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
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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.
Zhao Weili, MD principal investigator
Ruijin Hospital, Shanghai Jiaotong University School of Medicine Recruiting Shanghai, Shanghai, China, 200025
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 LY007 in people with B-NHL, run by Shanghai Longyao Biotechnology Inc., 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 17 inclusion and 28 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 28 Feb 2024. 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 Zhao Weili, MD (+862164370045 ext. 610707, zwl_trial@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose or clinically recommended dose (time frame: Day0 to 2year). The study lists 3 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 28 Feb 2024.