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New treatment option for High-risk R/R LBCL
Official title CAR-T Combined With ASCT in the Treatment of Relapsed/Refractory Large B-cell Lymphoma With High-risk Factors.
ClinicalTrials.gov ID: NCT07538635
What this study is testing
What is Axicabtagene Ciloleucel?
Axicabtagene Ciloleucel is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for high-risk r/r lbcl.
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 prospective, single-arm, single-center, open-label clinical study, aiming to evaluate the efficacy and safety of CAR-T combined with ASCT in the treatment of relapsed/refractory large B-cell lymphoma with high-risk factors.
- Phase 2: a mid-size study of how well it works
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
- Age ≥ 18 years
- Histopathologically confirmed large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBL), central...
- Must have received first-line treatment with a regimen containing anti-CD20 monoclonal antibody and anthracycline
- Meet one of the following clinical high-risk factors or molecular biological high-risk factors:
- Clinical high-risk factors: Failure to achieve partial response (PR) after 4 cycles of first-line immunochemotherapy; or relapse within 12 months...
You likely can't join if
- Patients who have previously received any CD19-targeted therapy
- Patients with CD19 negativity confirmed by immunohistochemistry (IHC)
- Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, defined as HBV DNA or HCV RNA level above the upper limit of normal (ULN), with...
- Presence of uncontrolled infection, cardio-cerebrovascular diseases, coagulopathy, or connective tissue diseases
- History of human immunodeficiency virus (HIV) infection
- Pregnant or lactating patients
See the full eligibility criteria
- Age ≥ 18 years
- Histopathologically confirmed large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBL), central nervous system lymphoma (CNSL), primary mediastinal large B-cell lymphoma...
- Must have received first-line treatment with a regimen containing anti-CD20 monoclonal antibody and anthracycline
- Meet one of the following clinical high-risk factors or molecular biological high-risk factors:
- Clinical high-risk factors: Failure to achieve partial response (PR) after 4 cycles of first-line immunochemotherapy; or relapse within 12 months after achieving complete response (CR) with first-line...
- Molecular biological high-risk factors: TP53 gene mutation; or high-grade B-cell lymphoma (HGBL) with MYC and Bcl-2 rearrangements, with or without Bcl-6 rearrangement
- ECOG 0 to 2
- Eligible for high-dose chemotherapy/autologous hematopoietic stem cell transplantation (HDCT/ASCT) per the investigator's assessment, and planned to receive a sequential regimen of ASCT followed by CAR-T therapy
- Hepatic and renal function meet the following criteria: Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ 3 × upper limit of normal (ULN); total bilirubin ≤ 1.5 mg/dL; serum creatinine ≤ 1.5 × ULN...
- Left ventricular ejection fraction (LVEF) ≥ 40%
- Life expectancy ≥ 3 months
- Patients who have previously received any CD19-targeted therapy
- Patients with CD19 negativity confirmed by immunohistochemistry (IHC)
- Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, defined as HBV DNA or HCV RNA level above the upper limit of normal (ULN), with or without liver function abnormalities
- Presence of uncontrolled infection, cardio-cerebrovascular diseases, coagulopathy, or connective tissue diseases
- History of human immunodeficiency virus (HIV) infection
- Pregnant or lactating patients
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhengjiang, 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 Hangzhou, Zhengjiang, 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.