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New treatment option for B-cell Non-Hodgkin Lymphoma Recurrent B-cell Non-Hodgkin Lymphoma...
Official title Targeting CD19/CD20 Dual-targeted Cell in Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
ClinicalTrials.gov ID: NCT07093411
What this study is testing
What is LUCAR-E9D or LUCAR-E9K cells product?
LUCAR-E9D or LUCAR-E9K cells product is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for b-cell non-hodgkin lymphoma recurrent b-cell non-hodgkin lymphoma refractory.
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
- A phase I, open-label clinical study to evaluate the safety, tolerability, and efficacy of LUCAR-E9D,LUCAR-E9K, a dual-targeted cell preparation targeting CD19/CD20, in patients with relapsed/refractory B-cell non-Hodgkin 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 to 75
You may be able to join if
- people have fully understood the possible risks and benefits of participating in this study, are willing to follow and able to complete all trial...
- Aged 18-75 years (inclusive).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Histologically confirmed B-cell non-Hodgkin Lymphoma that expresses at least one of CD19/CD20.
- At least one evaluable tumor lesion according to Lugano 2014 criteria.
You likely can't join if
- Diagnosed with or treated for other invasive malignancies besides B-cell non-Hodgkin lymphoma.
- Active acute or chronic graft-versus-host disease (GVHD), except for grade 1 skin involvement; or requiring immunosuppressive treatment for GVHD...
- Active CNS involvement (symptomatic or positive cerebrospinal fluid or imaging data), prior CNS infiltration but currently in remission (asymptomatic...
- Significant bleeding tendency, such as gastrointestinal bleeding, hemorrhagic cystitis, coagulopathy.
- Chronic diseases treated with steroids or other immunosuppressants. The following situations are excluded: use of topical, ocular, intra-articular...
- Severe underlying diseases, such as: - Evidence of severe active viral, bacterial infections, or uncontrolled systemic fungal infections; - Active or...
See the full eligibility criteria
- people have fully understood the possible risks and benefits of participating in this study, are willing to follow and able to complete all trial procedures and have signed informed consent.
- Aged 18-75 years (inclusive).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Histologically confirmed B-cell non-Hodgkin Lymphoma that expresses at least one of CD19/CD20.
- At least one evaluable tumor lesion according to Lugano 2014 criteria.
- Response to prior therapy is consistent with one of the following: 1） Patients with B-NHL who are primary refractory and are unsuitable or unwilling to receive autologous CAR-T cell therapy; 2） primary refractory is...
- Diagnosed with or treated for other invasive malignancies besides B-cell non-Hodgkin lymphoma.
- Active acute or chronic graft-versus-host disease (GVHD), except for grade 1 skin involvement; or requiring immunosuppressive treatment for GVHD within 4 weeks prior to enrollment;
- Active CNS involvement (symptomatic or positive cerebrospinal fluid or imaging data), prior CNS infiltration but currently in remission (asymptomatic and negative cerebrospinal fluid and/or imaging data) is eligible;
- Significant bleeding tendency, such as gastrointestinal bleeding, hemorrhagic cystitis, coagulopathy.
- Chronic diseases treated with steroids or other immunosuppressants. The following situations are excluded: use of topical, ocular, intra-articular, intranasal, and inhaled corticosteroids; short-term use of...
- Severe underlying diseases, such as: - Evidence of severe active viral, bacterial infections, or uncontrolled systemic fungal infections; - Active or unstable autoimmune diseases, or autoimmune diseases within the past...
- Breastfeeding women;
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, China
- Xi'an, China
- Xuzhou, 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 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, China; Xi'an, China; Xuzhou, 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.