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New treatment option for B-cell Non Hodgkin Lymphoma
Official title CAR-T Following ASCT for Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (R/R B-NHL) With High-Risk Prognostic Factors
ClinicalTrials.gov ID: NCT06365671
What this study is testing
What is Relmacabtagene autoleucel (relma-cel)?
Relmacabtagene autoleucel (relma-cel) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for b-cell non hodgkin 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
- Clinical trial for the safety and efficacy of CD19 CAR-T following autologous hematopoietic stem cell transplantation (ASCT) for Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (R/R B-NHL) with High-Risk Prognostic 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
- Histologically confirmed B-cell non-Hodgkin's lymphoma including the following types
- diffuse large B-cell lymphoma
- high-grade B-cell lymphoma with or without MYC and BLC2 and/or BCL6 rearrangement
- transformed lymphoma
- primary mediastinal large B-cell lymphoma
You likely can't join if
- History of autologous or allogeneic stem cell transplantation
- Active HBV or HCV infection, defined as HBV-DNA or HCV-DNA levels above the normal upper limit, with or without abnormal liver function. Individuals...
- Presence of uncontrolled infection, cardio-cerebrovascular disease，coagulopathy, or connective tissue disease.
- History of HIV infection
- Prior chimeric antigen receptor cellular immunotherapy targeting CD19
- Pregnant or lactating patients
See the full eligibility criteria
- Histologically confirmed B-cell non-Hodgkin's lymphoma including the following types
- diffuse large B-cell lymphoma
- high-grade B-cell lymphoma with or without MYC and BLC2 and/or BCL6 rearrangement
- transformed lymphoma
- primary mediastinal large B-cell lymphoma
- follicular lymphoma (FL)
- Relapsed or refractory diseases fulfilling one of the following criteria (individuals must have received anti-CD20 monoclonal antibody and anthracycline-containing chemotherapy regimen)
- Primary refractory disease, defined as disease progression after first-line immunochemotherapy or disease progression within 6 weeks of the end of the last chemotherapy
- Stable disease (SD) as best response after at least 4 cycles of first-line therapy
- Partial response (PR) as best response after at least 6 cycles of first-line therapy (biopsy-proven residual disease is needed for individuals with Deauville score of 4)
- PR as best response after at least 2 cycles of second-line therapy
- Disease relapse ≤12 months after the completion of first-line immunochemotherapy
- Relapsed or refractory disease after ≥2 lines of chemotherapy
- Presence of at least one of the following high-risk prognostic factors: (1) extranodal involvement; (2) maximum diameter of the bulky mass ≥5 cm; (3) TP53 gene alterations
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Eligible for HDCT/ASCT based on the investigator's assessment and are scheduled to undergo an ASCT sequential CAR-T treatment regimen
- Adequate renal and hepatic function defined as:
- Serum alanine aminotransferase (ALT/AST) ≤ 3 upper limit of normal (ULN)
- Total bilirubin ≤1.5 mg/dL(\<3 times ULN in patients with Gilbert's syndrome, cholestasis due to hepatoportal compression adenopathy, biliary obstruction in patients with liver involvement or lymphoma)
- Serum creatinine ≤1.5 ULN, or creatinine clearance (as estimated by Cockcroft Gault) ≥ 30 mL/min
- Cardiac ejection fraction ≥ 40%
- Baseline oxygen saturation \> 95% on room air
- Life expectancy ≥3 months
- History of autologous or allogeneic stem cell transplantation
- Active HBV or HCV infection, defined as HBV-DNA or HCV-DNA levels above the normal upper limit, with or without abnormal liver function. Individuals with positive HBsAg or HBcAb should receive antiviral prophylaxis for...
- Presence of uncontrolled infection, cardio-cerebrovascular disease，coagulopathy, or connective tissue disease.
- History of HIV infection
- Prior chimeric antigen receptor cellular immunotherapy targeting CD19
- Pregnant or lactating patients
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, 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 Shanghai, 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.