B Cell LymphomaPhase 1NCT06180174
Clinical Research of CD19 Targeted CAR-T Cell in Relapsed/Refractory B Cell Lymphoma
A Phase 1 study testing MC-1-50 in people with B Cell Lymphoma and Non Hodgkin Lymphoma, run by Chongqing Precision Biotech Co., Ltd at 1 site in China.
Trial summary
This is a single-arm, open-label, dose-escalation phase I clinical study to explore the safety, tolerability, and cytokinetic characteristics of MC-1-50 cell formulation, and to preliminarily observe the efficacy of MC-1-50 cell formulation in subjects with relapsed/refractory CD19-positive B-cell non-Hodgkin lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B Cell Lymphoma, Non Hodgkin Lymphoma
- What is being tested?
- MC-1-50
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2023to 31 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- The patient or his/her guardian agrees to participate in the clinical trial and signs the ICF, indicating that he/she understands the purpose and procedure of the clinical trial and is willing to participate in the study;
- Age ≥18 years old, gender unlimited;
- Confirmed cytological or histological diagnosis of B-cell non-Hodgkin lymphoma according to WHO 2017 criteria, including the following pathological types:
- Diffuse large B-cell lymphoma: including non-specific type (DLBCL, NOS), chronic inflammatory associated DLBCL, primary cutaneous DLBCL (leg type), EBV-positive DLBCL (NOS);
- High-grade B-cell lymphomas (including NOS and high-grade B-cell lymphomas with MYC and BCL2 and/or BCL6 rearrangements);
- Primary mediastinal large B-cell lymphoma;
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- Rich T/ histiocytic large B-cell lymphoma;
- Transformed DLBCL (e.g., transformed DLBCL of follicular lymphoma, chronic lymphocytic leukemia/small B lymphocytic lymphoma, marginal zone lymphoma, etc.);
- Grade 3b follicular lymphoma (FL3b);
- Have received adequate treatment with CD20 monoclonal antibody and anthracyclines in the past (except for those who are negative for CD20 and anthracyclines, or who are unable to tolerate or adapt to CD20 monoclonal antibody therapy or have other conditions in which the use of CD20 monoclonal antibody is not considered appropriate by the investigators), For those who are allergic to CD20 monoclonal antibody, or have intolerable serious adverse reactions after use, or have active infections and serious cardiovascular problems, etc.), the definition of relapse or refractory is met during screening:
- Recurrence: recurrence of disease progression or recurrence after achieving CR with standard treatment;
- Difficult to treat: The best curative effect after at least 4 courses of first-line treatment/at least 2 courses of end-line treatment (2 lines and more) is disease stabilization (SD), and the SD maintenance time after the last dose is not more than 6 months; Or the best response to the last treatment was disease progression (PD);
- No remission, disease progression or recurrence after autologous hematopoietic stem cell transplantation;
- Patients with transformational lymphoma who received chemotherapy prior to transformation and did not go into remission, disease progression, or relapse after salvage therapy after transformation.
- Immunohistochemical or flow cytometry results showed positive CD19 expression;
- ECOG 0 ~ 1 points;
- The expected survival time is 12 weeks or more;
- According to the 2014 edition of Lugano standard, there is at least one two-dimensional measurable lesion as the evaluation basis: for intranodular lesion, it is defined as: long diameter >1.5cm; For extranodal lesions, the length diameter should be >1.0cm;
- The functions of important organs are basically normal:
- Cardiac function: cardiac echocardiography suggests cardiac ejection fraction ≥50%;
- Serum creatinine ≤2.0× ULN, or creatinine clearance ≥60ml/min (CockcroftGault formula);
- ALT and AST≤3.0×ULN (≤5.0×ULN for patients with liver invasion);
- Total bilirubin ≤1.5 ×ULN (total bilirubin ≤3.0 ×ULN in Gilbert syndrome);
- Blood oxygen saturation ≥92% in non-oxygen state;
- Blood routine: neutrophils ≥1.0×109/L, platelets ≥75×109/L, hemoglobin ≥80g/L (with bone marrow invasion, neutrophils ≥0.5×109/L, platelets ≥50×109/L).
- No serious mental disorders;
- The venous access required for collection can be established, and mononuclear cell collection can be performed according to the judgment of the researcher, and there are no contraindications for other cell collection;
- Women of childbearing age who have had a negative pregnancy test and all subjects agree to use a reliable and effective contraceptive method for contraception (excluding safe period contraception) for 1 year from signing the informed consent to receiving the infusion of MC-1-50 cells. Including but not limited to: abstinence, can inhibit ovulation implantable progesterone contraceptive; Intrauterine device (IUD); Intrauterine hormone release system; Spousal vasectomy; Combined hormonal contraceptives (oral, vaginal, and transdermal) that inhibit ovulation; Progesterone contraceptives (oral or injectable) that inhibit ovulation; Male subjects who have sex with a fertile female must consent to the use of a barrier method of contraception (e.g., condom plus spermicidal foam/gel/film/emulsion/suppository). At the same time, the subject should promise not to donate eggs (egg cells, oocytes) or sperm for assisted reproduction within 1 year after the cell infusion.
Who cannot join
- Secondary CNS lymphoma was allowed to be included, except those with active CNS invasion or symptoms of CNS involvement or primary CNS lymphoma at the time of screening;
- Patients who have received CAR-T therapy or other gene-modified cell therapy before screening;
- Received allogeneic hematopoietic stem cell transplantation (allo-HSCT) before screening;
- Received the following anti-tumor therapy before cell infusion: received chemotherapy, targeted therapy and other drug treatment (preconditioning) within 14 days or at least 5 half-lives (whichever is longer)
- Except for therapy and sheath chemotherapy for CNS lymphoma, which should be stopped 1 week before cell infusion); Received radiation within 14 days;
- Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA detection greater than the normal range; Hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA detection greater than the normal range; Positive for human immunodeficiency virus (HIV) antibodies; Syphilis positive; Cytomegalovirus (CMV) DNA test positive;
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- Have any of the following heart conditions:
- New York Heart Association (NYHA) Stage III or IV congestive heart failure;
- Had myocardial infarction or coronary artery bypass grafting (CABG) within 6 months prior to enrollment;
- A history of clinically significant ventricular arrhythmia, or unexplained syncope (other than those caused by vasovagal or dehydration);
- History of severe non-ischemic cardiomyopathy;
- Active or uncontrollable infection requiring systemic treatment exists within 1 week prior to screening;
- Grade 2 to 4 acute graft-versus-host disease (GVHD) or moderate to severe chronic GVHD were present within 4 weeks prior to screening;
- Cerebrovascular accident or seizure occurred within 6 months before screening;
- Occurrence of deep vein or deep artery embolization events within 6 months before screening;
- Poor control of hypertension at screening, defined as systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg (blood pressure values are measured based on the average of 3 readings taken at least 2 minutes apart
- Patients with blood pressure ≥160/100mmHg at the initial screening can receive antihypertensive treatment, and if the blood pressure is well controlled after treatment and the blood pressure < 160/100mmHg can be screened);
- Known to have active or uncontrolled autoimmune diseases, such as Crohns disease, rheumatoid arthritis, systemic lupus erythematosus, systemic vasculitis, etc., except skin diseases that do not require systemic treatment (e.g. Psoriasis);
- Screening for interstitial lung disease requiring treatment;
- Malignant tumors other than B-cell non-Hodgkin's lymphoma (except tumors with no active lesion and after treatment > 2 years, and adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, ductal carcinoma in situ after radical surgery);
- Received live attenuated vaccine within 4 weeks prior to screening;
- Participated in other interventional clinical studies within 4 weeks or 5 half-lives prior to screening;
- Women who are pregnant or breastfeeding, as well as male or female subjects who plan to have a family within 1 year after receiving MC-1-50 cell transfusion;
- Circumstances deemed unsuitable for participation in the study by other researchers.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality
Yuqin Song, MD, 88196118 ext. 010, songyq_vip@163.com
About this study
Official title: Phase I Clinical Study of CD19-targeting Chimeric Antigen Receptor T Lymphocyte (MC-1-50) Formulation for the Treatment of Relapsed/Refractory CD19-positive B-cell Non-Hodgkin Lymphoma (B-NHL)
This is a single-arm, open-label, dose-escalation phase I clinical study to explore the safety, tolerability, and cytokinetic characteristics of MC-1-50 cell formulation, and to preliminarily observe the efficacy of MC-1-50 cell formulation in subjects with relapsed/refractory CD19-positive B-cell non-Hodgkin lymphoma.
Read the detailed description
Based on the specific CD19-targeting CAR-T developed on the PrimeCARTM platform, the cell preparation time is about 3 days, which can greatly shorten the waiting time of patients, improve production efficiency and reduce production costs. At the same time, MC-1-50 products have a high proportion of T naive cells, which can play a therapeutic effect at a very small infusion dose to improve safety. In this study, a "3+3" design was adopted, and four dose groups were set up with 1×105/kg, 3×105/kg, 5×105/kg, and 10×105/kg CAR-positive cells, respectively (the upper limit of the total number of cells was not more than 1×108 CAR-positive cells). All subjects received only one infusion of MC-1-50 cells.
- Conditions
- B Cell Lymphoma, Non Hodgkin Lymphoma
- Being tested
- MC-1-50
- Keywords
- CAR-T, CD19
- Medical subject headings
- Lymphoma, B-Cell, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MC-1-50Biological
A single infusion of CD19 CAR-T cells will be administered intravenously after lymphodepletion
| Study group | Role | What they receive |
|---|---|---|
| MC-1-50 cell preparation | Experimental | Patients will be be treated with CD19 CAR- T cells Receives: Biological: MC-1-50 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The incidence of adverse events after CAR-T cell infusion was assessed by the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 5.0)
Measured: 1 month
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Dose-limiting toxicity after CD19 CAR-T cell infusion
Measured: 1month
Secondary outcomes (9)
Assessing objective response rate(ORR) of CAR-T cell preparations in CD19-positive relapsed/refractory B-cell non-Hodgkin lymphoma[Effectiveness]
Objective response rate after infusion 1 month and 3 month: The proportion of subjects who achieved CR, PR after CAR-T infusion accounted for all treated subjects (Assessed by investigators according to the Lugano 2014 criteria)#the minimum value is 0%#maximum value is 100%, and higher scores mean a better outcome.
Measured: 3 months
Assessing best overall response rate(BOR) of CAR-T cell preparations in CD19-positive relapsed/refractory B-cell non-Hodgkin lymphoma[Effectiveness]
Best overall response rate rate after infusion 1 month and 3 month: proportion of patients who achieve optimal response (CR or PR) with MC-1-50 cell therapy (Assessed by investigators according to the Lugano 2014 criteria)#the minimum value is 0%#maximum value is 100%, and higher scores mean a better outcome.
Measured: 3 months
Assessing best complete response rate(CRR) of CAR-T cell preparations in CD19-positive relapsed/refractory B-cell non-Hodgkin lymphoma[Effectiveness]
Complete response rate rate after infusion 1 month and 3 month: proportion of patients who achieve CR with MC-1-50 cell therapy (Assessed by investigators according to the Lugano 2014 criteria)#the minimum value is 0%#maximum value is 100%, and higher scores mean a better outcome.
Measured: 3 months
Assessing best partial response rate(PRR) of CAR-T cell preparations in CD19-positive relapsed/refractory B-cell non-Hodgkin lymphoma[Effectiveness]
Partial response rate rate after infusion 1 month and 3 month: proportion of patients who achieve PR with MC-1-50 cell therapy (Assessed by investigators according to the Lugano 2014 criteria)#the minimum value is 0%#maximum value is 100%, and higher scores mean a better outcome.
Measured: 3 months
AUCS of MC-1-50 cell preparation [Cell dynamics]
AUCS is defined as the area under the curve in 90 days
Measured: 3 months
CMAX of MC-1-50 cell preparation [Cell dynamics]
CMAX is defined as the highest concentration of CEA CAR-T cells expanded in peripheral blood
Measured: 3 months
TMAX of MC-1-50 cell preparation[Cell dynamics]
TMAX is defined as the time to reach the highest concentration
Measured: 3 months
Pharmacodynamics of MC-1-50 cell preparation[Cell dynamics]
The clearance degree of CD19-positive B cells in peripheral blood was detected by flow cytometry at the visit points specified in the research protocol
Measured: 3 months
To evaluate the immunogenicity positive rate of MC-1-50 cell preparation after infusion
The anti-CAR antibody was detected by ELISAt the visit points specified in the research protocol
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 posted22 Dec 2023
- Study start31 Dec 2023 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B Cell 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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing Precision Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Peking University Cancer Hospital & Institute
- Responsible party
- Sponsor
- Investigators
- Yuqin Song, M.D, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06180174
- Sponsor's protocol ID
- PB10
- Status last verified
- Dec 2023
- First submitted
- 12 Dec 2023
- Last updated
- 28 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Study of CD19-targeting Chimeric Antigen Receptor T Lymphocyte (MC-1-50) Formulation for the Treatment of Relapsed/Refractory CD19-positive B-cell Non-Hodgkin Lymphoma (B-NHL)
- ClinicalTrials.gov ID
- NCT06180174
- Acronym / sponsor ID
- PB10
- Conditions
- B Cell Lymphoma, Non Hodgkin Lymphoma
- Keywords
- CAR-T, CD19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Chongqing Precision Biotech Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Peking University Cancer Hospital & Institute
- Study start
- 31 Dec 2023 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Dec 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.
This is a single-arm, open-label, dose-escalation phase I clinical study to explore the safety, tolerability, and cytokinetic characteristics of MC-1-50 cell formulation, and to preliminarily observe the efficacy of MC-1-50 cell formulation in subjects with relapsed/refractory CD19-positive B-cell non-Hodgkin lymphoma.
Detailed description
Based on the specific CD19-targeting CAR-T developed on the PrimeCARTM platform, the cell preparation time is about 3 days, which can greatly shorten the waiting time of patients, improve production efficiency and reduce production costs. At the same time, MC-1-50 products have a high proportion of T naive cells, which can play a therapeutic effect at a very small infusion dose to improve safety. In this study, a "3+3" design was adopted, and four dose groups were set up with 1×105/kg, 3×105/kg, 5×105/kg, and 10×105/kg CAR-positive cells, respectively (the upper limit of the total number of cells was not more than 1×108 CAR-positive cells). All subjects received only one infusion of MC-1-50 cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MC-1-50 cell preparation | Experimental | Biological: MC-1-50Patients will be be treated with CD19 CAR- T cells |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- The patient or his/her guardian agrees to participate in the clinical trial and signs the ICF, indicating that he/she understands the purpose and procedure of the clinical trial and is willing to participate in the study;
- Age ≥18 years old, gender unlimited;
- Confirmed cytological or histological diagnosis of B-cell non-Hodgkin lymphoma according to WHO 2017 criteria, including the following pathological types:
- Have received adequate treatment with CD20 monoclonal antibody and anthracyclines in the past (except for those who are negative for CD20 and anthracyclines, or who are unable to tolerate or adapt to CD20 monoclonal antibody therapy or have other conditions in which the use of CD20 monoclonal antibody is not considered appropriate by the investigators), For those who are allergic to CD20 monoclonal antibody, or have intolerable serious adverse reactions after use, or have active infections and serious cardiovascular problems, etc.), the definition of relapse or refractory is met during screening:
- Immunohistochemical or flow cytometry results showed positive CD19 expression;
Key exclusion criteria (24 listed)
- Secondary CNS lymphoma was allowed to be included, except those with active CNS invasion or symptoms of CNS involvement or primary CNS lymphoma at the time of screening;
- Patients who have received CAR-T therapy or other gene-modified cell therapy before screening;
- Received allogeneic hematopoietic stem cell transplantation (allo-HSCT) before screening;
- Received the following anti-tumor therapy before cell infusion: received chemotherapy, targeted therapy and other drug treatment (preconditioning) within 14 days or at least 5 half-lives (whichever is longer)
- Except for therapy and sheath chemotherapy for CNS lymphoma, which should be stopped 1 week before cell infusion); Received radiation within 14 days;
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 |
|---|---|---|
| MC-1-50A single infusion of CD19 CAR-T cells will be administered intravenously after lymphodepletion | Biological | MC-1-50 cell preparation |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 1 month
The incidence of adverse events after CAR-T cell infusion was assessed by the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 5.0)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 1month
Dose-limiting toxicity after CD19 CAR-T cell infusion
9 secondary outcomes
Assessing objective response rate(ORR) of CAR-T cell preparations in CD19-positive relapsed/refractory B-cell non-Hodgkin lymphoma[Effectiveness]
Time frame: 3 months
Assessing best overall response rate(BOR) of CAR-T cell preparations in CD19-positive relapsed/refractory B-cell non-Hodgkin lymphoma[Effectiveness]
Time frame: 3 months
Assessing best complete response rate(CRR) of CAR-T cell preparations in CD19-positive relapsed/refractory B-cell non-Hodgkin lymphoma[Effectiveness]
Time frame: 3 months
Assessing best partial response rate(PRR) of CAR-T cell preparations in CD19-positive relapsed/refractory B-cell non-Hodgkin lymphoma[Effectiveness]
Time frame: 3 months
AUCS of MC-1-50 cell preparation [Cell dynamics]
Time frame: 3 months
CMAX of MC-1-50 cell preparation [Cell dynamics]
Time frame: 3 months
TMAX of MC-1-50 cell preparation[Cell dynamics]
Time frame: 3 months
Pharmacodynamics of MC-1-50 cell preparation[Cell dynamics]
Time frame: 3 months
To evaluate the immunogenicity positive rate of MC-1-50 cell preparation after infusion
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2023.
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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.
Yuqin Song, M.D principal investigator
Peking University Cancer Hospital & Institute
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 MC-1-50 in people with B Cell Lymphoma and 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 28 inclusion and 24 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: looking for participants now, as of the sponsor's last update on 28 Dec 2023. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuqin Song, M.D (88196118 ext. 010, songyq_vip@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: 1 month). 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 28 Dec 2023.