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New treatment option for Diffuse Large B-cell-lymphoma
Official title Clinical Study of C402-CD19-CAR Treatment in Subjects With Relapsed or Refractory B-cell Lymphoma
ClinicalTrials.gov ID: NCT06830031
What this study is testing
What is C402-CD19-CAR?
C402-CD19-CAR is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for diffuse large 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 study is to investigate the safety and tolerability of C402-CD19-CAR treatment in subjects with relapsed or refractory large B-cell lymphoma and further determine the recommended Phase 2 dose of C402-CD19-CAR.
- 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 to 75
You may be able to join if
- Must meet all the following
- Male or female 18-75 years (inclusive);
- Patients can understand this study and capable of providing informed consent;
- Patients with willingness to be in the study and comply with the study visit procedures and other protocol requirements;
- Diagnosed with CD19-positive large B-cell lymphoma (LBCL) based on cytology or histology according to the WHO 2016 standards, including diffuse large...
You likely can't join if
- History of receiving allogeneic hematopoietic stem cell transplantation, adoptive cell therapy (such as CAR-T therapy), or other gene-modified cell...
- Any active central nervous system (CNS) involvement (including symptomatic and asymptomatic), or a history of CNS disease (such as epilepsy, cerebral...
- Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA positivity, or people with HBV...
- Any unstable systemic disease, including but not limited to unstable angina, cerebrovascular accident or transient ischemic attack (within 6 months...
- Presence of malignant tumors other than large B-cell lymphoma, except for cured non-melanoma skin cancer, carcinoma in situ of the cervix, localized...
- Presence of gastric lymphoma, bulky disease, a history of CD19+ leukemia, or active autoimmune diseases (e.g., systemic lupus erythematosus...
See the full eligibility criteria
Who can join
- Must meet all the following
- Male or female 18-75 years (inclusive);
- Patients can understand this study and capable of providing informed consent;
- Patients with willingness to be in the study and comply with the study visit procedures and other protocol requirements;
- Diagnosed with CD19-positive large B-cell lymphoma (LBCL) based on cytology or histology according to the WHO 2016 standards, including diffuse large B-cell lymphoma not otherwise specified (DLBCL-NOS), grade 3b...
- For refractory or relapsed large B-cell lymphoma people, must have received at least anthracycline-based therapy and rituximab (or other CD20-targeted drugs, excluding CD20-negative cases). If previously treated with...
- According to the 2014 Lugano Treatment Response Assessment Criteria, at least one measurable tumor lesion should be present (lesions can be measured with PET results; lymph node lesions [long axis LDi \> 15mm] or extra...
- Expected survival time greater than 12 weeks;
- ECOG score of 0-1;
- Able to establish an intravenous route for PBMC collection, meeting the following hematologic parameters before screening: Hemoglobin ≥ 80 g/L, absolute neutrophil count ≥ 1.0 × 10\^9/L, platelet count ≥ 75 × 10\^9/L...
- Liver and kidney function, as well as heart and lung function, should meet the following requirements:
- Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min (using the Cockcroft-Gault formula);
- Ejection fraction ≥ 50%, with no clinically significant pericardial effusion or pleural effusion detected;
- Oxygen saturation ≥ 92% without oxygen support;
- Total bilirubin ≤ 1.5 × ULN (for patients with Gilbert's syndrome or lymphoma involving the liver, ≤ 3 × ULN);
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN;
- Fibrinogen ≥ 1.0 g/L; activated partial thromboplastin time ≤ 1.5 × ULN, prothrombin time (PT) ≤ 1.5 × ULN;
- No more than 1 month prior to screening, the subject must have participated in another treatment clinical study and recovered to a severity level of ≤ 1 for any treatment-related adverse events.
What rules you out
- History of receiving allogeneic hematopoietic stem cell transplantation, adoptive cell therapy (such as CAR-T therapy), or other gene-modified cell therapies;
- Any active central nervous system (CNS) involvement (including symptomatic and asymptomatic), or a history of CNS disease (such as epilepsy, cerebral ischemia/hemorrhage, dementia, cerebellar disorders, or any...
- Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA positivity, or people with HBV titers above the upper limit of the normal range for the study center...
- Any unstable systemic disease, including but not limited to unstable angina, cerebrovascular accident or transient ischemic attack (within 6 months prior to screening), myocardial infarction (within 6 months prior to...
- Presence of malignant tumors other than large B-cell lymphoma, except for cured non-melanoma skin cancer, carcinoma in situ of the cervix, localized prostate cancer, superficial bladder cancer, ductal carcinoma in situ...
- Presence of gastric lymphoma, bulky disease, a history of CD19+ leukemia, or active autoimmune diseases (e.g., systemic lupus erythematosus, Sjögren's syndrome, rheumatoid arthritis, psoriasis, multiple sclerosis...
- Presence of uncontrolled active infections requiring treatment (e.g., sepsis, bacteremia, fungemia, viremia) (mild urinary tract infections or upper respiratory tract infections are exceptions), with the exception of...
- people who have received systemic steroid treatment within 2 weeks before PBMC collection and are determined by the investigator to require long-term systemic steroid treatment during the treatment period (except for...
- people who have received anti-tumor treatment within 8 weeks or 5 half-lives (specific medications need to be assessed in detail) before PBMC collection, including chemotherapy, CD20-targeted therapy, etc.; local...
- people who have used granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) within 4 weeks before PBMC collection or within at least 5 half-lives (whichever is...
- people who have received alendronate treatment within 6 months before PBMC collection, or who have received fludarabine, cladribine, or bendamustine treatment within 3 months before PBMC collection;
- people who have undergone major surgery within 4 weeks prior to screening (as defined by "Clinical Application Measures of Medical Technology" and "Grade 3 and 4 surgeries") or who have not fully recovered from any...
- people who have received a live vaccine within 28 days before PBMC collection;
- Pregnant or breastfeeding women, or those who plan to become pregnant during the treatment period or within 2 years after treatment, or male people whose partners plan to become pregnant within 2 years after male...
- people whom the investigator deems unsuitable to participate in this trial.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, 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 to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, 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.