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New treatment option for Large B Cell Diffuse Lymphoma
Official title Relmacabtagene Autoleucel Combined With Sintilimab for Relapsed/Refractory B-cell Lymphoma
ClinicalTrials.gov ID: NCT07077512
What this study is testing
What is Autoleucel (Relmacabtagene Autoleucel)?
Autoleucel (Relmacabtagene Autoleucel) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for large b cell diffuse lymphoma.
Also referred to as Chimeric Antigen Receptor T-Cell (CAR-T) Therapy.
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, multicenter, phase II clinical trial to evaluate the efficacy and safety of Relmacabtagene Autoleucel in combination with the Sintilimab regimen for the treatment of relapsed/refractory B-cell lymphoma
- 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 to 70
You may be able to join if
- The patient must be aware of and voluntarily sign the informed consent form (ICF).
- Aged between 18 and 70 years, both male and female.
- Pathologically diagnosed with DLBCL, FL, or MCL, with histological confirmation of CD19 positivity (immunohistochemistry or flow cytometry, with flow...
- The patient must be willing to receive regorafenib and sintilimab treatment and be deemed suitable for this treatment by the investigator.
- Relapsed/refractory DLBCL, FL, or MCL.
You likely can't join if
- History of another malignancy that has not been in complete remission for at least 2 years, except for: non-melanoma skin cancer, completely resected...
- Active Hepatitis B: a) Positive for Hepatitis B surface antigen (HBsAg) and/or Hepatitis B core antibody (HBcAb) , with HBV-DNA below the lower limit...
- Hepatitis C, HIV, or syphilis infection.
- Uncontrolled systemic fungal, bacterial, viral, or other infections.
- Acute or chronic graft-versus-host disease (GVHD).
- Known hypersensitivity or allergy to any study drug or excipient.
See the full eligibility criteria
- The patient must be aware of and voluntarily sign the informed consent form (ICF).
- Aged between 18 and 70 years, both male and female.
- Pathologically diagnosed with DLBCL, FL, or MCL, with histological confirmation of CD19 positivity (immunohistochemistry or flow cytometry, with flow cytometry used for re-evaluation if immunohistochemistry is...
- The patient must be willing to receive regorafenib and sintilimab treatment and be deemed suitable for this treatment by the investigator.
- Relapsed/refractory DLBCL, FL, or MCL.
- At least one measurable or evaluable lesion.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
- Expected survival of ≥3 months.
- Adequate function of the heart, lungs, liver, kidneys, and other organs.
- History of another malignancy that has not been in complete remission for at least 2 years, except for: non-melanoma skin cancer, completely resected stage I tumors with low recurrence potential, treated localized...
- Active Hepatitis B: a) Positive for Hepatitis B surface antigen (HBsAg) and/or Hepatitis B core antibody (HBcAb) , with HBV-DNA below the lower limit of the reference value can be included.
- Hepatitis C, HIV, or syphilis infection.
- Uncontrolled systemic fungal, bacterial, viral, or other infections.
- Acute or chronic graft-versus-host disease (GVHD).
- Known hypersensitivity or allergy to any study drug or excipient.
- Clinically significant central nervous system (CNS) disease or symptoms, such as epilepsy, seizures, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain...
- Pregnant or breastfeeding women, and women of childbearing age who do not wish to use contraception.
- Mentally ill individuals or those unable to provide informed consent.
- The investigator deems the patient unsuitable for the study due to medical, psychological, familial, social, or geographical reasons or an inability to comply with the study protocol.
- Previous CAR-T cell therapy or other gene-modified T-cell treatments.
- Previous CD19-targeted therapy.
- Previous allogeneic hematopoietic stem cell transplantation.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, 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 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, 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.