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New treatment option for B Cell Lymphoma
Official title Clinical Research of CD19 Targeted CAR-T Cell in Relapsed/Refractory B Cell Lymphoma
ClinicalTrials.gov ID: NCT06180174
What this study is testing
What is MC-1-50?
MC-1-50 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for b cell lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
- Diffuse large B-cell lymphoma: including non-specific type (DLBCL, NOS), chronic inflammatory associated DLBCL, primary cutaneous DLBCL (leg type)...
- High-grade B-cell lymphomas (including NOS and high-grade B-cell lymphomas with MYC and BCL2 and/or BCL6 rearrangements);
You likely can't join if
- Secondary CNS lymphoma was allowed to be included, except those with active CNS invasion or symptoms of CNS involvement or primary CNS lymphoma at...
- 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)...
- Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA detection greater...
- Have any of the following heart conditions:
See the full eligibility criteria
Who can 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...
- 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;
- 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...
- 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...
- 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...
- 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 people agree to use a reliable and effective contraceptive method for contraception (excluding safe period contraception) for 1 year from signing...
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- Received live attenuated vaccine within 4 weeks prior to screening;
- Participated in other treatment clinical studies within 4 weeks or 5 half-lives prior to screening;
- Women who are pregnant or breastfeeding, as well as male or female people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.