BridgeMD
Tests treatment safety and results for Relapsed/Refractory Diffuse Large B-cell Lymphoma
Official title Safety and Efficacy of Early Second Infusion of Axi-cel Based on ctDNA for R/R Large B - Cell Lymphoma
ClinicalTrials.gov ID: NCT06902012
What this study is testing
What is Infusion of Axicabtagene Ciloleucel?
Infusion of Axicabtagene Ciloleucel is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for relapsed/refractory 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 goal of this clinical trial is to evaluate the efficacy and safety of early secondary infusion of CD19 CAR T-cell therapy in adults with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), guided by ctDNA monitoring. The main questions it aims to answer are: 1.
- 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, regardless of gender.
- Life expectancy \>12 weeks.
- ECOG performance status 0-2.
- Histologically or cytologically confirmed B-cell non-Hodgkin lymphoma per WHO 2016 classification, including: Diffuse large B-cell lymphoma (DLBCL)...
- Relapsed/refractory disease, defined as: ≥1 prior relapse, Failure to achieve partial response (PR) after 2-3 cycles of first-line therapy, Failure...
You likely can't join if
- History of malignancies other than DLBCL, PMBCL, TFL, or HGBCL within 5 years prior to screening, except: Adequately treated carcinoma in situ of the...
- Unstable systemic diseases, including but not limited to: Active infections (excluding localized infections), Unstable angina, Cerebrovascular...
- Conditions affecting informed consent or protocol compliance: Physical or psychological disorders impairing the ability to provide written informed...
- Grade ≥3 cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) following prior axi-cel therapy.
- Active, uncontrolled serious infections.
- Uncontrolled active comorbidities that preclude study participation.
See the full eligibility criteria
- Age ≥18 years, regardless of gender.
- Life expectancy \>12 weeks.
- ECOG performance status 0-2.
- Histologically or cytologically confirmed B-cell non-Hodgkin lymphoma per WHO 2016 classification, including: Diffuse large B-cell lymphoma (DLBCL) Primary mediastinal large B-cell lymphoma (PMBCL) Transformed...
- Relapsed/refractory disease, defined as: ≥1 prior relapse, Failure to achieve partial response (PR) after 2-3 cycles of first-line therapy, Failure to achieve complete response (CR) after 4-6 cycles of first-line...
- Adequate venous access for leukapheresis, with: Hemoglobin ≥80 g/L, Absolute neutrophil count ≥1.0 ×10⁹/L, Platelet count ≥75 ×10⁹/L, OR parameters not meeting above thresholds but deemed acceptable for mononuclear cell...
- ≥1 measurable lesion per Lugano 2014 response criteria.
- Organ function requirements: Renal: Serum creatinine ≤2×ULN OR creatinine clearance ≥40 mL/min (Cockcroft-Gault formula). Cardiopulmonary: Left ventricular ejection fraction (LVEF) \>50%, Baseline oxygen saturation...
- Negative serum pregnancy test for women of childbearing potential (WOCBP). Postmenopausal (≥2 years since last menses) or surgically sterilized women are exempt.
- Within 60 days post-axi-cel: Persistent ctDNA(+) or ctDNA(-→+) under CR or PET/CT-confirmed PR
- History of malignancies other than DLBCL, PMBCL, TFL, or HGBCL within 5 years prior to screening, except: Adequately treated carcinoma in situ of the cervix, Basal cell or squamous cell carcinoma of the skin, Localized...
- Unstable systemic diseases, including but not limited to: Active infections (excluding localized infections), Unstable angina, Cerebrovascular accident or transient ischemic attack (within 6 months prior to screening)...
- Conditions affecting informed consent or protocol compliance: Physical or psychological disorders impairing the ability to provide written informed consent, Inability or unwillingness to comply with study requirements.
- Grade ≥3 cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) following prior axi-cel therapy.
- Active, uncontrolled serious infections.
- Uncontrolled active comorbidities that preclude study participation.
- Other conditions deemed by the investigator to confer unacceptable risk or render the patient ineligible.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, 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 Guangzhou, Guangdong, 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.