An Early Phase 1 interventional study of LUCAR-E9D or LUCAR-E9K cells product in B-cell Non-Hodgkin Lymphoma Recurrent B-cell Non-Hodgkin Lymphoma Refractory, sponsored by Beijing GoBroad Hospital. Recruiting at 3 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-08-20.
Sponsored by Beijing GoBroad Hospital · Early Phase 1, Interventional, and Treatment
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.
This is an open-label, dose-escalation/dose extension study to assess the safety, tolerability, and efficacy of LUCAR-E9D,LUCAR-E9K in the patient ≥ 18 years of age with relapsed or refractory B-cell non-Hodgkin lymphoma. Subjects who meet the eligibility criteria will receive a single dose of LUCAR-E9D,LUCAR-E9K injection. The study will include the following sequential phases: screening, pre-treatment (lymphodepleting chemotherapy), treatment, and follow-up.
Beijing GoBroad Hospital is the lead sponsor of 35 studies on the registry; 35 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
Each subject will be given a single-dose LUCAR-E9D or LUCAR-E9K cells infusion at each dose level.
Biological: LUCAR-E9D or LUCAR-E9K cells product
Prior to infusion of the LUCAR-E9D or LUCAR-E9K cells product subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine
Incidence, severity and type of TEAEs (Treatment-emergent Adverse Events)
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Time frame: 2 years after LUCAR-E9D,LUCAR-E9K infusion
Pharmacokinetics in peripheral blood
CAR positive T cells and CAR transgene levels in peripheral blood after LUCAR-E9D,LUCAR-E9K infusion.
Time frame: 2 years after LUCAR-E9D,LUCAR-E9K infusion
Pharmacokinetics in bone marrow
CAR positive T cells and CAR transgene levels in bone marrow after LUCAR-E9D,LUCAR-E9K infusion.
Time frame: 2 years after LUCAR-E9D,LUCAR-E9K infusion
The recommended Phase II dose (RP2D) for this cell therapy
RP2D established through ATD+BOIN design and the DLTs occurring following CAR T-cell infusion
Time frame: 30 days after LUCAR-E9D,LUCAR-E9K infusion
Overall Response Rate (ORR)
Objective Response Rate (ORR) is defined as the proportion of subjects who achieve CR or PR after treatment via LUCAR-E9D,LUCAR-E9Kcell infusion
Time frame: Through study completion, 2 years after LUCAR-E9D,LUCAR-E9K infusion
Progression-free survival (PFS)
Progression Free Survival (PFS) is defined as the time from the date of first infusion of the LUCAR-E9D, LUCAR-E9K to the first documented disease progression (according to Lugano 2014) or death (due to any cause), whichever occurs first
Time frame: Through study completion, 2 years after LUCAR-E9D,LUCAR-E9K infusion
Overall Survival (OS)
Overall Survival (OS) is defined as the time from the date of first infusion of LUCAR-E9D,LUCAR-E9Kto death of the subject
Time frame: Through study completion, 2 years after LUCAR-E9D,LUCAR-E9K infusion
Time to Response (TTR)
Time to Response (TTR) is defined as the time from the date of first infusion of LUCAR-E9D,LUCAR-E9Kto the date of the first response evaluation of the subject who has met all criteria for CR or PR.
Time frame: Through study completion, minimum 2 years after LUCAR-E9D,LUCAR-E9K infusion (Day 1)
Time to Response (TTR)
Time to Response (TTR) is defined as the time from the date of first infusion of LUCAR-E9D,LUCAR-E9Kto the date of the first response evaluation of the subject who has met all criteria for CR or PR.
Time frame: Through study completion, 2 years after LUCAR-E9D,LUCAR-E9K infusion
Duration of Response (DoR)
Duration of Remission (DoR) is defined as the time from the first documentation of remission (CR or PR) to the first documented relapse evidence of the responders.
Time frame: Through study completion, minimum 2 years after LUCAR-E9D,LUCAR-E9K infusion (Day 1)
Immunogenicity assessment of LUCAR-E9D or LUCAR-E9Kcells
The incidence of Anti- LUCAR-E9D or LUCAR-E9Kantibody in patients who received LUCAR-E9D,LUCAR-E9Kcells infusion
Time frame: Through study completion, 2 years after LUCAR-E9D,LUCAR-E9K infusion
Plan to share: No
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Beijing GoBroad Hospital