Relapsed and Refractory B-cell Non-Hodgkin LymphomaPhase 1NCT06295549
Targeting CD19/CD20 Dual-targeted Cell in Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
A Phase 1 study testing LUCAR-G39P cells product in people with Relapsed and Refractory B-cell Non-Hodgkin Lymphoma, run by The First Affiliated Hospital with Nanjing Medical University at 3 sites in China.
Trial summary
A phase I, open-label clinical study to evaluate the safety, tolerability, and efficacy of LUCAR-G39P, 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
- Relapsed and Refractory B-cell Non-Hodgkin Lymphoma
- What is being tested?
- LUCAR-G39P cells product
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 3 sitesChina
- Study dates
- 11 Apr 2024to 22 Aug 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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:
Show all 12Show fewer
- Primary refractory.
- Relapsed or refractory after 2 or more lines of therapy.
- For LBCL, 3B FL. t-iNHL:
- Relapse within 12 months after first-line chemoimmunotherapy to achieve CR;
- Progression or relapse within 12 months after autologous hematopoietic stem cell transplantation;
- 7. Life expectancy≥ 3 months 8. Clinical laboratory values meet screening visit criteria
Who cannot join
- Subject eligible for this study must not meet any of the following criteria:
- Prior antitumor therapy with insufficient washout period ;
- Patients who received autologous CAR-T cell therapy (except CD19-targeted) or autologous gene therapy;
- Patients who received allogeneic hematopoietic stem cell transplantation or allogeneic therapy;
- 5. Patients who are positive for any index of hepatitis B surface antigen (HBsAg), hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C antibody (HCV-Ab), hepatitis C virus ribonucleic acid (HCV RNA), or human immunodeficiency virus antibody (HIV- Ab).
- 6. Known life-threatening allergies, hypersensitivity, or intolerance to LUCAR-G39P CAR-T cell or its excipients, including DMSO.
- 7. Pregnant or lactating women;
- -
Trial locations and contacts
3 sites in 1 country.
China3 sites
Beijing Gobroad Hosptial
Beijing, 102206
Department of Haematology, the First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital
Nanjin, Jiangsu, 210029
Affiliated Hospital of Nantong University
Nantong, Jiangsu, 226001
About this study
Official title: A Phase I, Open-label Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of LUCAR-G39P, a Dual-targeted Cell Preparation 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-G39P, a dual-targeted cell preparation targeting CD19/CD20, in patients with relapsed/refractory B-cell non-Hodgkin lymphoma
Read the detailed description
his is an open-label, dose-escalation/dose extension study to assess the safety, tolerability, and efficacy of LUCAR-G39P 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-G39P injection. The study will include the following sequential phases: screening, pre-treatment (lymphodepleting chemotherapy), treatment, and follow-up.
- Being tested
- LUCAR-G39P cells product
- Medical subject headings
- Recurrence, Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LUCAR-G39P cells productBiological
LUCAR-G39P cells product Prior to infusion of the LUCAR-G39P, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine
| Study group | Role | What they receive |
|---|---|---|
| Experimental: LUCAR-G39P cells product | Experimental | Each subject will be given a single-dose LUCAR-G39P cells infusion at each dose level. Receives: Biological: LUCAR-G39P 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
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: Through study completion , an average of 2 years after LUCAR-G39P infusion (Day 1)
Pharmacokinetics in peripheral blood
CAR positive T cells and CAR transgene levels in peripheral blood after LUCAR-G39P infusion
Measured: ThTrough study completion , an average of 2 years after LUCAR-G39P infusion (Day 1)
Pharmacokinetics in bone marrow
CAR positive T cells and CAR transgene levels in bone marrow after LUCAR-G39P infusion.
Measured: ThTrough study completion , an average of 2 years after LUCAR-G39P infusion (Day 1)
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: Within 30 days after LUCAR-G39P infusion
Secondary outcomes (6)
Overall Response Rate (ORR)
Objective Response Rate (ORR) is defined as the proportion of subjects who achieve CR or PR after treatment via LUCAR-G39P cell infusion
Measured: Through study completion, an average of 2 years after LUCAR-G39P infusion (Day 1)
Progression-free survival (PFS)
rogression Free Survival (PFS) is defined as the time from the date of first infusion of the LUCAR-G39P to the first documented disease progression (according to Lugano 2014) or death (due to any cause), whichever occurs first
Measured: Through study completion, an average of 2 years after LUCAR-G39P infusion (Day 1)
Overall Survival (OS)
Overall Survival (OS) is defined as the time from the date of first infusion of LUCAR-G39P to death of the subject
Measured: Through study completion, an average of 2 years after LUCAR-G39P infusion (Day 1)
Time to Response (TTR)
Time to Response (TTR) is defined as the time from the date of first infusion of LUCAR-G39P to the date of the first response evaluation of the subject who has met all criteria for CR or PR
Measured: Through study completion, an average of 2 years after LUCAR-G39P infusion (Day 1)
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, an average of 2 years after LUCAR-G39P infusion (Day 1)
Immunogenicity assessment of LUCAR-G39P cells
The incidence of Anti- LUCAR-G39P antibody in patients who received LUCAR-G39P cells infusion
Measured: Through study completion, an average of 2 years after LUCAR-G39P infusion (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start11 Apr 2024
- Primary completion11 Jun 2025
- Study completion22 Aug 2025
Why it stopped: Achieve the proof of concept.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed and Refractory B-cell Non-Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Nanjing Legend Biotech Co.
- Responsible party
- Sponsor
- Investigators
- Jianyong Li, PhD,MD, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06295549
- Sponsor's protocol ID
- LB2304-0001
- Status last verified
- Oct 2024
- First submitted
- 18 Feb 2024
- Last updated
- 1 Dec 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 1 Dec 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-G39P, a Dual-targeted Cell Preparation Targeting CD19/CD20, in Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT06295549
- Acronym / sponsor ID
- LB2304-0001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Achieve the proof of concept.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Nanjing Legend Biotech Co.
- Study start
- 11 Apr 2024 (actual)
- Primary completion
- 11 Jun 2025 (actual)
- Study completion
- 22 Aug 2025 (actual)
- First posted
- 6 Mar 2024 (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-G39P, a dual-targeted cell preparation targeting CD19/CD20, in patients with relapsed/refractory B-cell non-Hodgkin lymphoma
Detailed description
his is an open-label, dose-escalation/dose extension study to assess the safety, tolerability, and efficacy of LUCAR-G39P 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-G39P 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 |
|---|---|---|
| Experimental: LUCAR-G39P cells product | Experimental | Biological: LUCAR-G39P cells productEach subject will be given a single-dose LUCAR-G39P 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 (12 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 (8 listed)
- 5. Patients who are positive for any index of hepatitis B surface antigen (HBsAg), hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C antibody (HCV-Ab), hepatitis C virus ribonucleic acid (HCV RNA), or human immunodeficiency virus antibody (HIV- Ab).
- 6. Known life-threatening allergies, hypersensitivity, or intolerance to LUCAR-G39P CAR-T cell or its excipients, including DMSO.
- 7. Pregnant or lactating women;
- -
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-G39P cells productLUCAR-G39P cells product Prior to infusion of the LUCAR-G39P, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine | Biological | Experimental: LUCAR-G39P cells product |
Primary outcome
Incidence, severity and type of TEAEs
Time frame: Through study completion , an average of 2 years after LUCAR-G39P infusion (Day 1)
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: ThTrough study completion , an average of 2 years after LUCAR-G39P infusion (Day 1)
CAR positive T cells and CAR transgene levels in peripheral blood after LUCAR-G39P infusion
Pharmacokinetics in bone marrow
Time frame: ThTrough study completion , an average of 2 years after LUCAR-G39P infusion (Day 1)
CAR positive T cells and CAR transgene levels in bone marrow after LUCAR-G39P infusion.
The recommended Phase II dose (RP2D) for this cell therapy
Time frame: Within 30 days after LUCAR-G39P infusion
RP2D established through ATD+BOIN design and the DLTs occurring following CAR T-cell infusion
6 secondary outcomes
Overall Response Rate (ORR)
Time frame: Through study completion, an average of 2 years after LUCAR-G39P infusion (Day 1)
Progression-free survival (PFS)
Time frame: Through study completion, an average of 2 years after LUCAR-G39P infusion (Day 1)
Overall Survival (OS)
Time frame: Through study completion, an average of 2 years after LUCAR-G39P infusion (Day 1)
Time to Response (TTR)
Time frame: Through study completion, an average of 2 years after LUCAR-G39P infusion (Day 1)
Duration of Response (DoR)
Time frame: Through study completion, an average of 2 years after LUCAR-G39P infusion (Day 1)
Immunogenicity assessment of LUCAR-G39P cells
Time frame: Through study completion, an average of 2 years after LUCAR-G39P infusion (Day 1)
Results and safety
The study was stopped early (reason given: Achieve the proof of concept.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 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. This study is not recruiting at the moment.
Jianyong Li, PhD,MD principal investigator
The First Affiliated Hospital with Nanjing Medical University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LUCAR-G39P cells product in people with Relapsed and Refractory B-cell Non-Hodgkin Lymphoma, run by The First Affiliated Hospital with Nanjing Medical University 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 12 inclusion and 8 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: stopped early, as of the sponsor's last update on 1 Dec 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Achieve the proof of concept.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence, severity and type of TEAEs (time frame: Through study completion , an average of 2 years after LUCAR-G39P infusion (Day 1)). 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 1 Dec 2025.