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Tests treatment safety and results for Diffuse Large B Cell Lymphoma
Official title Safety and Efficacy Study of Anti-PD1 Armored CD19 CAR-T Cells in Adult Subjects With Relapsed or Refractory Diffuse Large B-cell Lymphoma
ClinicalTrials.gov ID: NCT07368270
What this study is testing
What is Anti-PD1 armored CD19 CAR-T cells?
Anti-PD1 armored CD19 CAR-T cells is an investigational medicine, given as an infusion into a vein, 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
- The purpose of this study is to investigate the safety and tolerability of anti-PD1 armored CD19 CAR-T Cells in adult subjects with relapsed or refractory diffuse large B-cell 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
- 1\. people voluntarily participate in clinical research and sign informed consent.
- 2\. Adult people (age ≥18 ) with relapsed or refractory diffuse large B-cell lymphoma: a) failure to achieve CR after 6 cycles, or PR after 3 cycles...
- 3\. Expected survival ≥ 3 months.
- 4\. At least one measurable lesion as per revised IWG response criteria for malignant lymphom (2014 Lugano criteria).
- 5\. CD19 positive expression are detected on tumor cells of people by flow cytometry or immunohistochemistry.
You likely can't join if
- 1\. Women who are pregnant or breastfeeding, or planned pregnancy within 6 months.
- 2\. Infectious disease(HIV, Active Tuberculosis ect.).
- 3\. Active infection: hepatitis B, hepatitis C.
- 4\. Abnormal vital signs or refuse to receive examination.
- 5\. people with psychiatric or psychological disorders are unable to complete treatment or how well it works assessment.
- 6.History of severe hypersensitivity or known hypersensitivity to IL-2.
See the full eligibility criteria
- 1\. people voluntarily participate in clinical research and sign informed consent.
- 2\. Adult people (age ≥18 ) with relapsed or refractory diffuse large B-cell lymphoma: a) failure to achieve CR after 6 cycles, or PR after 3 cycles, of first-line therapy, or achieve CR after first-line therapy but...
- 3\. Expected survival ≥ 3 months.
- 4\. At least one measurable lesion as per revised IWG response criteria for malignant lymphom (2014 Lugano criteria).
- 5\. CD19 positive expression are detected on tumor cells of people by flow cytometry or immunohistochemistry.
- 6\. ECOG score ≤ 2.
- 7\. people with adequate organ functions prior to enrollment, meet the following laboratory values:
- Renal function: serum creatinine ≤ 1.5 × ULN or estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m².
- Hepatic function: Serum alanine aminotransferase (ALT) ≤ 5 × age-specific ULN and total bilirubin ≤ 2.0 mg/dL, except in people with Gilbert-Meulengracht syndrome. If total bilirubin ≤ 3.0 × ULN and direct bilirubin ≤...
- Pulmonary reserve: ≤ Grade 1 dyspnea and oxygen saturation \>95% on room air.
- 8\. Stable hemodynamics and left ventricular ejection fraction (LVEF) ≥ 45 % assessed by echocardiography or multi-gated radionuclide angiography (MUGA).
- 9\. Adequate bone-marrow reserve without blood transfusion as defined by:
- Absolute neutrophil count (ANC) ≥ 1 x 10\^9/L.
- Absolute lymphocyte count (ALC) ≥ 0.1 x 10\^9/L.
- Platelets ≥ 50 x 10\^9/L.
- Hemoglobin \>80g/L.
- 10\. In the investigator's judgment, people' general condition and all biochemical values are either normal or sufficiently compensated to receive lymphodepletion and CAR-T cell therapy.
- 1\. Women who are pregnant or breastfeeding, or planned pregnancy within 6 months.
- 2\. Infectious disease(HIV, Active Tuberculosis ect.).
- 3\. Active infection: hepatitis B, hepatitis C.
- 4\. Abnormal vital signs or refuse to receive examination.
- 5\. people with psychiatric or psychological disorders are unable to complete treatment or how well it works assessment.
- 6.History of severe hypersensitivity or known hypersensitivity to IL-2.
- 7\. Systemic or local severe infection requiring antimicrobial therapy.
- 8\. Significant dysfunction of vital organs (heart, lung, brain, kidney, etc.), or in the investigator's judgment, people are unable to be enrolled with any other condition.
The study team makes the final eligibility decision.
Where it's taking place
- Suzhou, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 Suzhou, 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.