B-cell Non-Hodgkin Lymphoma Recurrent B-cell Non-Hodgkin Lymphoma RefractoryEarly Phase 1NCT07093411
Targeting CD19/CD20 Dual-targeted Cell in Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
A Early Phase 1 study testing LUCAR-E9D or LUCAR-E9K cells product in people with B-cell Non-Hodgkin Lymphoma Recurrent B-cell Non-Hodgkin Lymphoma Refractory, run by Beijing GoBroad Hospital at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- B-cell Non-Hodgkin Lymphoma Recurrent B-cell Non-Hodgkin Lymphoma Refractory
- What is being tested?
- LUCAR-E9D or LUCAR-E9K cells product
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 3 sitesChina
- Study dates
- 5 Aug 2025to Dec 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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 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;
Who cannot join
- 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 corticosteroids for prophylaxis;
- 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;
- Breastfeeding women;
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
Hefei
Bing Xing Wang
- Recruiting
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an
Hong wan Zhao
- Recruiting
Affiliated Hospital of Xuzhou Medical University
Xuzhou
Wei Sang
About this study
Official title: A Phase I, Open-label Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of LUCAR-E9D,LUCAR-E9K, a Dual-targeted Cell Product Targeting CD19/CD20, in Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
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.
Read the detailed description
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.
- Being tested
- LUCAR-E9D or LUCAR-E9K cells product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LUCAR-E9D or LUCAR-E9K cells productBiological
Prior to infusion of the LUCAR-E9D or LUCAR-E9K cells product subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine
| Study group | Role | What they receive |
|---|---|---|
| LUCAR-E9D or LUCAR-E9K | Experimental | Each subject will be given a single-dose LUCAR-E9D or LUCAR-E9K cells infusion at each dose level. Receives: Biological: LUCAR-E9D or LUCAR-E9K cells product |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 30 days after LUCAR-E9D,LUCAR-E9K infusion
Secondary outcomes (7)
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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Through study completion, 2 years after LUCAR-E9D,LUCAR-E9K infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start5 Aug 2025
- Primary completionAug 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell Non-Hodgkin Lymphoma Recurrent B-cell Non-Hodgkin Lymphoma RefractoryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing GoBroad Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Wenzhou Medical University, The First Affiliated Hospital of Zhengzhou University, The Affiliated Hospital of Xuzhou Medical University, Second Affiliated Hospital of Xi'an Jiaotong University, Anhui Provincial Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07093411
- Sponsor's protocol ID
- LB2406-0001
- Status last verified
- Jun 2025
- First submitted
- 14 Jul 2025
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of LUCAR-E9D,LUCAR-E9K, a Dual-targeted Cell Product Targeting CD19/CD20, in Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT07093411
- Acronym / sponsor ID
- LB2406-0001
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Beijing GoBroad HospitalUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Wenzhou Medical University, The First Affiliated Hospital of Zhengzhou University, The Affiliated Hospital of Xuzhou Medical University, Second Affiliated Hospital of Xi'an Jiaotong University, Anhui Provincial Hospital
- Study start
- 5 Aug 2025 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 30 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LUCAR-E9D or LUCAR-E9K | Experimental | Biological: LUCAR-E9D or LUCAR-E9K cells productEach subject will be given a single-dose LUCAR-E9D or LUCAR-E9K cells infusion at each dose level. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
- 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.
Key exclusion criteria (7 listed)
- 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 corticosteroids for prophylaxis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LUCAR-E9D or LUCAR-E9K cells productPrior to infusion of the LUCAR-E9D or LUCAR-E9K cells product subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine | Biological | LUCAR-E9D or LUCAR-E9K |
Primary outcome
Incidence, severity and type of TEAEs (Treatment-emergent Adverse Events)
Time frame: 2 years after LUCAR-E9D,LUCAR-E9K infusion
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.
Pharmacokinetics in peripheral blood
Time frame: 2 years after LUCAR-E9D,LUCAR-E9K infusion
CAR positive T cells and CAR transgene levels in peripheral blood after LUCAR-E9D,LUCAR-E9K infusion.
Pharmacokinetics in bone marrow
Time frame: 2 years after LUCAR-E9D,LUCAR-E9K infusion
CAR positive T cells and CAR transgene levels in bone marrow after LUCAR-E9D,LUCAR-E9K infusion.
The recommended Phase II dose (RP2D) for this cell therapy
Time frame: 30 days after LUCAR-E9D,LUCAR-E9K infusion
RP2D established through ATD+BOIN design and the DLTs occurring following CAR T-cell infusion
7 secondary outcomes
Overall Response Rate (ORR)
Time frame: Through study completion, 2 years after LUCAR-E9D,LUCAR-E9K infusion
Progression-free survival (PFS)
Time frame: Through study completion, 2 years after LUCAR-E9D,LUCAR-E9K infusion
Overall Survival (OS)
Time frame: Through study completion, 2 years after LUCAR-E9D,LUCAR-E9K infusion
Time to Response (TTR)
Time frame: Through study completion, minimum 2 years after LUCAR-E9D,LUCAR-E9K infusion (Day 1)
Time to Response (TTR)
Time frame: Through study completion, 2 years after LUCAR-E9D,LUCAR-E9K infusion
Duration of Response (DoR)
Time frame: Through study completion, minimum 2 years after LUCAR-E9D,LUCAR-E9K infusion (Day 1)
Immunogenicity assessment of LUCAR-E9D or LUCAR-E9Kcells
Time frame: Through study completion, 2 years after LUCAR-E9D,LUCAR-E9K infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing LUCAR-E9D or LUCAR-E9K cells product in people with B-cell Non-Hodgkin Lymphoma Recurrent B-cell Non-Hodgkin Lymphoma Refractory, run by Beijing GoBroad Hospital at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kai Hu (+86 15010390336, huk@gobroadhealthcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence, severity and type of TEAEs (Treatment-emergent Adverse Events) (time frame: 2 years after LUCAR-E9D,LUCAR-E9K infusion). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025; AzTrials last refreshed its copy on 6 Nov 2026.