NCT07093411 Targeting CD19/CD20 Dual-targeted Cell in Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
| NCT ID | NCT07093411 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Beijing GoBroad Hospital |
| Condition | B-cell Non-Hodgkin Lymphoma Recurrent B-cell Non-Hodgkin Lymphoma Refractory |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2025-08-05 |
| Primary Completion | 2028-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 48 participants in total. It began in 2025-08-05 with a primary completion date of 2028-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Subjects 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. 2. Aged 18-75 years (inclusive). 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4. Histologically confirmed B-cell non-Hodgkin Lymphoma that expresses at least one of CD19/CD20. 5. At least one evaluable tumor lesion according to Lugano 2014 criteria. 6. 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 defined as the best response to first-line treatment being SD or PD; 3） Relapse within 12 months after achieving CR with first-line chemotherapy and immunotherapy; 7. Life expectancy≥ 3 months 8. Women of childbearing potential must have a negative highly sensitive serum pregnancy test (β-human chorionic gonadotropin \[β-hCG\]) at screening and before the first administration of cyclophosphamide and fludarabine treatment; Exclusion Criteria: 1. Diagnosed with or treated for other invasive malignancies besides B-cell non-Hodgkin lymphoma. 2. 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; 3. 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; 4. Significant bleeding tendency, such as gastrointestinal bleeding, hemorrhagic cystitis, coagulopathy. 5. 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 corticosteroids for prophylaxis; 6. 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 3 years with potential for relapse; 7. Breastfeeding women;
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07093411 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying B-cell Non-Hodgkin Lymphoma Recurrent B-cell Non-Hodgkin Lymphoma Refractory. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07093411 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07093411 currently recruiting?
Yes, NCT07093411 is actively recruiting participants. Contact the research team at huk@gobroadhealthcare.com for enrollment information.
Where is the NCT07093411 trial being conducted?
This trial is being conducted at Hefei, China, Xi'an, China, Xuzhou, China.
Who is sponsoring the NCT07093411 clinical trial?
NCT07093411 is sponsored by Beijing GoBroad Hospital. The trial plans to enroll 48 participants.