Relapsed Non-Hodgkin LymphomaPhase 1NCT05420493
Clinical Study of Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of Relapsed/Refractory Non-Hodgkin Lymphoma
A Phase 1 study testing CAR-T cells in people with Relapsed Non-Hodgkin Lymphoma and Refractory Non-Hodgkin Lymphoma, run by Chongqing Precision Biotech Co., Ltd at 1 site in China.
Trial summary
This is a phase I clinical study to evaluate the safety and efficacy of CAR-T infusion preparation in the treatment of CD19-positive relapsed/refractory non-Hodgkin lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed Non-Hodgkin Lymphoma, Refractory Non-Hodgkin Lymphoma, Non Hodgkin Lymphoma
- What is being tested?
- CAR-T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- 6 Sep 2021to 30 Sep 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CD19-positive non-Hodgkin lymphoma confirmed by cytology or histology according to WHO2016 criteria:
- Diffuse large B-cell lymphoma: including unspecified (DLBCL, NOS), chronic inflammation-related DLBCL, primary cutaneous DLBCL (leg type), EBV-positive DLBCL (NOS); and high-grade B-cell lymphoma (including high-grade B-cell lymphoma, NOS, and high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements); and primary mediastinal large B-cell lymphoma; and T-cell-rich histiocytosis B-cell lymphoma; and transformed DLBCL (such as follicular lymphoma, chronic lymphocytic leukemia/small B-lymphocytic lymphoma transformed DLBCL); patients with the above tumor types have been treated with at least first- and second-line drugs and have stable disease for ≤12 months , or when the best Disease progression after efficacy; or disease progression or relapse after autologous stem cell transplantation ≤12 months;
- According to WHO2016 criteria cytology or histology confirmed CD19 positive: follicular cell lymphoma. Patients with this tumor type have received at least third-line therapy, and recurrence or disease progression has occurred within 2 years after third-line therapy or more. Currently in disease progression, stable disease, or partial remission;
- According to WHO2016 standard cytology or histology confirmed CD19 positive: mantle cell lymphoma. Such patients have not been cured or relapsed after at least three-line treatment and are not suitable for stem cell transplantation or relapse after stem cell transplantation;
- Age ≥18 years old (including the threshold);
- According to the 2014 version of Lugano criteria, there is at least one two-dimensional measurable lesion as the evaluation basis: for intranodal lesions, it is defined as: long diameter >1.5cm; for extranodal lesions, long diameter should be >1.0cm;
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- Eastern Cooperative Oncology Group activity status score ECOG score 0-2;
- The venous access required for collection can be established, and there are enough cells collected by non-mobilized apheresis for CAR-T cell production;
- Liver and kidney function, cardiopulmonary function meet the following requirements:
- Serum creatinine≤2.0×ULN;
- Left ventricular ejection fraction ≥ 50% and no obvious pericardial effusion, no abnormal ECG;
- Blood oxygen saturation ≥92% in non-oxygen state;
- Blood total bilirubin≤2.0×ULN (except without clinical significance);
- ALT and AST≤3.0×ULN (with liver tumor infiltration≤5.0×ULN);
- Be able to understand and voluntarily sign the informed consent.
Who cannot join
- Received CAR-T therapy or other gene-modified cell therapy before screening;
- Received anti-tumor therapy (except systemic immune checkpoint inhibition or stimulation therapy) within 2 weeks or 5 half-lives (whichever is shorter) before screening. 3 half-lives are required to enroll (eg, ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 receptor agonist, 4-1BB receptor agonist, etc.);
- Those who have received hematopoietic stem cell transplantation (ASCT) within 12 weeks before apheresis, or who have previously received allogeneic hematopoietic stem cell transplantation (HSCT), or those who have solid organ transplantation; immunosuppression is required within 2 weeks before apheresis Grade 2 and above GVHD of the drug;
- Patients with atrial or ventricular lymphoma involvement or need urgent treatment due to tumor mass such as intestinal obstruction or vascular compression;
- Have been vaccinated with live attenuated vaccine within 6 weeks before clearing the leprosy;
- Cerebrovascular accident or epilepsy occurred within 6 months before signing the ICF;
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- History of myocardial infarction, cardiac bypass or stent, unstable angina or other clinically significant heart disease within 12 months prior to signing the ICF;
- Active or uncontrolled autoimmune diseases (such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus), except those that do not require systemic treatment;
- Malignant tumors other than non-Hodgkin lymphoma within 5 years prior to screening, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical resection, Ductal carcinoma in situ;
- Uncontrollable infection within 1 week before screening;
- Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer detection is greater than the normal reference range; or hepatitis C virus (HCV) antibody positive and peripheral blood C Hepatitis virus (HCV) RNA titer test is greater than the normal reference range; or human immunodeficiency virus (HIV) antibody positive; or syphilis test positive; cytomegalovirus (CMV) DNA test positive;
- Women who are pregnant or breastfeeding; or women of childbearing age who have a positive pregnancy test during the screening period; or male or female patients who are unwilling to use contraception from the time of signing the informed consent form to 1 year after receiving CAR-T cell infusion;
- Other investigators deem it inappropriate to participate in the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shandong Second Provincial General Hospital
Jinan, Shandong, 250000
Jingwang Bi, MD, 13066029387, jingwangbi@live.cn
About this study
Official title: This is a Phase I Clinical Study to Evaluate the Safety and Efficacy of CAR-T Infusion Preparation in the Treatment of CD19-positive Relapsed/Refractory Non-Hodgkin Lymphoma.
This is a phase I clinical study to evaluate the safety and efficacy of CAR-T infusion preparation in the treatment of CD19-positive relapsed/refractory non-Hodgkin lymphoma.
Read the detailed description
This is a single-center, single-arm, open-label study. After meeting the eligibility criteria and enrolling on the trial, patients will undergo leukapheresis for collection of autologous lymphocytes. Once cells have been manufactured, patients will then proceed to lymphodepleting chemotherapy with cyclophosphamide and fludarabine for 1-2 consecutive days followed by the infusion of CAR T-cells at a target dose of 3-10x105 cells/kg.
- Being tested
- CAR-T cells
- Keywords
- CAR-T
- 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.
CAR-T cellsBiological
Drug: CAR-T cells； Administration method: intravenous infusion； Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous of CAR-T | Experimental | Infusion of CAR-T cells by dose of 3-10 x105 cells/kg Receives: Biological: CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse events after CAR-T cells infusion [Safety and Tolerability]
Therapy-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)
Measured: 28 days
Objective response rate after CAR-T cells infusion [Effectiveness]
Objective response rate includes CR,PR
Measured: 3 months
Secondary outcomes (4)
AUCS of CAR-T cells [Cell dynamics]
AUCS is defined as the area under the curve in 90 days
Measured: 3 months
CMAX of pCAR-19B cells [Cell dynamics]
CMAX is defined as the highest concentration of pCAR-19B cells expanded in peripheral blood
Measured: 3 months
TMAX of pCAR-19B cells [Cell dynamics]
TMAX is defined as the time to reach the highest concentration
Measured: 3 months
Pharmacodynamics of pCAR-19B cells[Cell dynamics]
IL-6 levels measured by Chemiluminescence method
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start6 Sep 2021
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 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 Chongqing Precision Biotech Co., LtdThe 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
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing Precision Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianfeng Bi, M.D, Principal investigator, Shandong Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05420493
- Sponsor's protocol ID
- PBC033
- Status last verified
- Nov 2023
- First submitted
- 12 Jun 2022
- Last updated
- 5 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- This is a Phase I Clinical Study to Evaluate the Safety and Efficacy of CAR-T Infusion Preparation in the Treatment of CD19-positive Relapsed/Refractory Non-Hodgkin Lymphoma.
- ClinicalTrials.gov ID
- NCT05420493
- Acronym / sponsor ID
- PBC033
- Keywords
- CAR-T
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Chongqing Precision Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 6 Sep 2021 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 15 Jun 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 a phase I clinical study to evaluate the safety and efficacy of CAR-T infusion preparation in the treatment of CD19-positive relapsed/refractory non-Hodgkin lymphoma.
Detailed description
This is a single-center, single-arm, open-label study. After meeting the eligibility criteria and enrolling on the trial, patients will undergo leukapheresis for collection of autologous lymphocytes. Once cells have been manufactured, patients will then proceed to lymphodepleting chemotherapy with cyclophosphamide and fludarabine for 1-2 consecutive days followed by the infusion of CAR T-cells at a target dose of 3-10x105 cells/kg.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intravenous of CAR-T | Experimental | Biological: CAR-T cellsInfusion of CAR-T cells by dose of 3-10 x105 cells/kg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- CD19-positive non-Hodgkin lymphoma confirmed by cytology or histology according to WHO2016 criteria:
- Age ≥18 years old (including the threshold);
- According to the 2014 version of Lugano criteria, there is at least one two-dimensional measurable lesion as the evaluation basis: for intranodal lesions, it is defined as: long diameter >1.5cm; for extranodal lesions, long diameter should be >1.0cm;
- Eastern Cooperative Oncology Group activity status score ECOG score 0-2;
- The venous access required for collection can be established, and there are enough cells collected by non-mobilized apheresis for CAR-T cell production;
Key exclusion criteria (13 listed)
- Received CAR-T therapy or other gene-modified cell therapy before screening;
- Received anti-tumor therapy (except systemic immune checkpoint inhibition or stimulation therapy) within 2 weeks or 5 half-lives (whichever is shorter) before screening. 3 half-lives are required to enroll (eg, ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 receptor agonist, 4-1BB receptor agonist, etc.);
- Those who have received hematopoietic stem cell transplantation (ASCT) within 12 weeks before apheresis, or who have previously received allogeneic hematopoietic stem cell transplantation (HSCT), or those who have solid organ transplantation; immunosuppression is required within 2 weeks before apheresis Grade 2 and above GVHD of the drug;
- Patients with atrial or ventricular lymphoma involvement or need urgent treatment due to tumor mass such as intestinal obstruction or vascular compression;
- Have been vaccinated with live attenuated vaccine within 6 weeks before clearing the leprosy;
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 |
|---|---|---|
| CAR-T cellsDrug: CAR-T cells； Administration method: intravenous infusion； Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion. | Biological | Intravenous of CAR-T |
Primary outcome
Incidence of Adverse events after CAR-T cells infusion [Safety and Tolerability]
Time frame: 28 days
Therapy-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)
Objective response rate after CAR-T cells infusion [Effectiveness]
Time frame: 3 months
Objective response rate includes CR,PR
4 secondary outcomes
AUCS of CAR-T cells [Cell dynamics]
Time frame: 3 months
CMAX of pCAR-19B cells [Cell dynamics]
Time frame: 3 months
TMAX of pCAR-19B cells [Cell dynamics]
Time frame: 3 months
Pharmacodynamics of pCAR-19B cells[Cell dynamics]
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 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.
Jianfeng Bi, M.D principal investigator
Shandong Provincial Hospital
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 CAR-T cells in people with Relapsed Non-Hodgkin Lymphoma and Refractory Non-Hodgkin Lymphoma, run by Chongqing Precision Biotech 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 15 inclusion and 13 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 5 Jan 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 Jingwang Bi, M.D (13066029387, jingwangbi@live.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse events after CAR-T cells infusion [Safety and Tolerability] (time frame: 28 days). 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 5 Jan 2024.