Relapsed B-cell Non-Hodgkin LymphomaPhase 1NCT06313957
A Study of LUCAR-20SP in Subjects With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
A Phase 1 study testing LUCAR-20SP cells in people with Relapsed B-cell Non-Hodgkin Lymphoma and Refractory B-cell Non-Hodgkin Lymphoma, run by Peking University Cancer Hospital & Institute at 3 sites in China.
Trial summary
This is a prospective, single-arm, open-label, exploratory clinical study of LUCAR-20SP in adult subjects with relapsed/refractory B-cell non-Hodgkin lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed B-cell Non-Hodgkin Lymphoma, Refractory B-cell Non-Hodgkin Lymphoma
- What is being tested?
- LUCAR-20SP cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 3 sitesChina
- Study dates
- 14 Mar 2024to Sep 2028
- Phase
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects voluntarily participate in clinical research;
- Age ≥18 years old;
- Eastern Cooperative Oncology Group (ECOG) score 0-1;
- Histologically confirmed large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, histologically indolent lymphoma to diffuse large B-cell lymphoma; CD20 positive;
- At least one measurable tumor lesion according to the Lugano 2014.
- Expected survival ≥3 months;
- Clinical laboratory values in the screening period meet criteria.
- Effective contraception.
Who cannot join
- Prior antitumor therapy with insufficient washout period.
- Previous treatment with allogeneic cell and gene therapy (such as CAR-T); Except subjects with evidence that previous allogeneic cell and gene therapy products (such as CAR-positive T cells and CAR transgenes) in the subject have been below the lower limit of detection;
- Previously received allogeneic hematopoietic stem cell transplantation;
- Previously received gene therapy;
- Donor specific antibody (DSA) positive subjects will be excluded;
- Severe underlying diseases;
- Hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C virus ribonucleic acid (HCV RNA) or human immunodeficiency virus antibody (HIV-Ab) positive;
- Presence of other serious pre-existing medical conditions that may limit patient participation in the study. Any condition that, in the investigator's judgment, will make the subject unsuitable for participation in this study.
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
Beijing GoBroad Boren Hospital
Beijing, Beijing Municipality, 100070
Yajing Zhang, 18501333856, zhangyj3@gobroadhealthcare.com
- Recruiting
Peking University Cancer Hospital & Institute
Beijing, Beijing Municipality, 100142
Yuqin Song, 13683398726, songyq22622@163.com
Yan Xie, 13671376201, xieyan9@263.net
- Recruiting
Henan Cancer Hospital
Zhengzhou
Keshu Zhou, 13674902391, drzhouks77@163.com
About this study
Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of LUCAR-20SP, an Allogenic Chimeric Antigen Receptor(CAR)-T Cell Therapy Targeting CD20 in Subjects With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
This is a prospective, single-arm, open-label, exploratory clinical study of LUCAR-20SP in adult subjects with relapsed/refractory B-cell non-Hodgkin lymphoma.
Read the detailed description
This is a prospective, single-arm, open-label exploratory clinical study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor efficacy profiles of LUCAR-20SP, an allogenic CAR-T cell therapy in subjects with relapsed/refractory B-cell non-Hodgkin lymphoma. Patients who meet the eligibility criteria will receive LUCAR-20SP infusion. The study will include the following sequential stages: screening, pre-treatment (lymphodepleting chemotherapy), treatment and follow-up.
- Being tested
- LUCAR-20SP cells
- Keywords
- Relapsed B-cell non-Hodgkin lymphoma, Refractory B-cell non-Hodgkin lymphoma
- Medical subject headings
- Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LUCAR-20SP cellsBiological
Prior to infusion of the LUCAR-20SP, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine.
| Study group | Role | What they receive |
|---|---|---|
| Each subject will receive LUCAR-20SP cells | Experimental | Chimeric antigen receptor T cells LUCAR-20SP cells Receives: Biological: LUCAR-20SP cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT) rate
DLT refers to a drug-related toxicity during treatment with the drug, the severity of which is clinically unacceptable, limiting the further escalation of drug dose.
Measured: Minimum 2 years after LUCAR-20SP infusion (Day 1)
Incidence, severity, and type of treatment-emergent adverse events (TEAEs)
An adverse event refers to any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product (investigational or non-investigational), which does not necessarily have a causal relationship with the treatment.
Measured: Minimum 2 years after LUCAR-20SP infusion (Day 1)
Recommended Phase 2 Dose (RP2D) regimen finding
RP2D established through accelerated titration design (ATD) and Bayesian Optimal Interval (BOIN) design.
Measured: Minimum 2 years after LUCAR-20SP infusion (Day 1)
Pharmacokinetics in peripheral blood
CAR transgene levels in peripheral blood after LUCAR-20SP infusion. CAR positive T cells levels in bone marrow after LUCAR-20SP infusion.
Measured: Minimum 2 years after LUCAR-20SP infusion (Day 1)
Pharmacokinetics in bone marrow
CAR positive T cells levels in bone marrow after LUCAR-20SP infusion. CAR transgene levels in bone marrow after LUCAR-20SP infusion.
Measured: Minimum 2 years after LUCAR-20SP infusion (Day 1)
Secondary outcomes (6)
Objective Response Rate (ORR) after administration
ORR is defined as the proportion of subjects who achieve complete response (CR) or partial response (PR) after treatment via LUCAR-20SP cell infusion, and the objective tumor response rate will be calculated for patients with measurable disease per the Lugano Classification for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma (Lugano 2014)
Measured: Minimum 2 years after LUCAR-20SP infusion (Day 1)
Time to Response (TTR) after administration
TTR is defined as the time from the date of first infusion of LUCAR-20SP to the date of the first response evaluation of the subject who has met all criteria for PR or better.
Measured: Minimum 2 years after LUCAR-20SP infusion (Day 1)
Duration of Remission (DoR) after administration
DoR is defined as the time from the first documentation of remission (PR or better) to the first documented disease progression evidence (according to Lugano 2014) of the responders (who achieve PR or better response).
Measured: Minimum 2 years after LUCAR-20SP infusion (Day 1)
Progression-free Survival (PFS) after administration
PFS is defined as the time from the date of first infusion of the LUCAR-20SP to the first documented disease progression (according to Lugano 2014) or death (due to any cause), whichever occurs first.
Measured: Minimum 2 years after LUCAR-20SP infusion (Day 1)]
Overall Survival (OS) after administration
OS is defined as the time from the date of first infusion of LUCAR-20SP to death of the subject.
Measured: Minimum 2 years after LUCAR-20SP infusion (Day 1)]
Incidence of anti-LUCAR-20SP antibody
The incidence of anti-LUCAR-20SP antibody in patients who received LUCAR-20SP infusion.
Measured: Minimum 2 years after LUCAR-20SP 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 posted15 Mar 2024
- Study start14 Mar 2024
- Primary completionSep 2026 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed B-cell Non-Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe 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
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Nanjing Legend Biotech Co., Beijing Boren Hospital, Henan Cancer Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06313957
- Sponsor's protocol ID
- LB2302-0001
- Status last verified
- Mar 2025
- First submitted
- 10 Mar 2024
- Last updated
- 25 Mar 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 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of LUCAR-20SP, an Allogenic Chimeric Antigen Receptor(CAR)-T Cell Therapy Targeting CD20 in Subjects With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT06313957
- Acronym / sponsor ID
- LB2302-0001
- Keywords
- Relapsed B-cell non-Hodgkin lymphoma, Refractory B-cell non-Hodgkin lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Collaborators
- Nanjing Legend Biotech Co., Beijing Boren Hospital, Henan Cancer Hospital
- Study start
- 14 Mar 2024 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 15 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.
This is a prospective, single-arm, open-label, exploratory clinical study of LUCAR-20SP in adult subjects with relapsed/refractory B-cell non-Hodgkin lymphoma.
Detailed description
This is a prospective, single-arm, open-label exploratory clinical study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor efficacy profiles of LUCAR-20SP, an allogenic CAR-T cell therapy in subjects with relapsed/refractory B-cell non-Hodgkin lymphoma. Patients who meet the eligibility criteria will receive LUCAR-20SP infusion. The study will include the following sequential stages: 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 |
|---|---|---|
| Each subject will receive LUCAR-20SP cells | Experimental | Biological: LUCAR-20SP cellsChimeric antigen receptor T cells LUCAR-20SP cells |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects voluntarily participate in clinical research;
- Age ≥18 years old;
- Eastern Cooperative Oncology Group (ECOG) score 0-1;
- Histologically confirmed large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, histologically indolent lymphoma to diffuse large B-cell lymphoma; CD20 positive;
- At least one measurable tumor lesion according to the Lugano 2014.
Key exclusion criteria (8 listed)
- Prior antitumor therapy with insufficient washout period.
- Previous treatment with allogeneic cell and gene therapy (such as CAR-T); Except subjects with evidence that previous allogeneic cell and gene therapy products (such as CAR-positive T cells and CAR transgenes) in the subject have been below the lower limit of detection;
- Previously received allogeneic hematopoietic stem cell transplantation;
- Previously received gene therapy;
- Donor specific antibody (DSA) positive subjects will be excluded;
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-20SP cellsPrior to infusion of the LUCAR-20SP, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine. | Biological | Each subject will receive LUCAR-20SP cells |
Primary outcome
Dose-limiting toxicity (DLT) rate
Time frame: Minimum 2 years after LUCAR-20SP infusion (Day 1)
DLT refers to a drug-related toxicity during treatment with the drug, the severity of which is clinically unacceptable, limiting the further escalation of drug dose.
Incidence, severity, and type of treatment-emergent adverse events (TEAEs)
Time frame: Minimum 2 years after LUCAR-20SP infusion (Day 1)
An adverse event refers to any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product (investigational or non-investigational), which does not necessarily have a causal relationship with the treatment.
Recommended Phase 2 Dose (RP2D) regimen finding
Time frame: Minimum 2 years after LUCAR-20SP infusion (Day 1)
RP2D established through accelerated titration design (ATD) and Bayesian Optimal Interval (BOIN) design.
Pharmacokinetics in peripheral blood
Time frame: Minimum 2 years after LUCAR-20SP infusion (Day 1)
CAR transgene levels in peripheral blood after LUCAR-20SP infusion. CAR positive T cells levels in bone marrow after LUCAR-20SP infusion.
Pharmacokinetics in bone marrow
Time frame: Minimum 2 years after LUCAR-20SP infusion (Day 1)
CAR positive T cells levels in bone marrow after LUCAR-20SP infusion. CAR transgene levels in bone marrow after LUCAR-20SP infusion.
6 secondary outcomes
Objective Response Rate (ORR) after administration
Time frame: Minimum 2 years after LUCAR-20SP infusion (Day 1)
Time to Response (TTR) after administration
Time frame: Minimum 2 years after LUCAR-20SP infusion (Day 1)
Duration of Remission (DoR) after administration
Time frame: Minimum 2 years after LUCAR-20SP infusion (Day 1)
Progression-free Survival (PFS) after administration
Time frame: Minimum 2 years after LUCAR-20SP infusion (Day 1)]
Overall Survival (OS) after administration
Time frame: Minimum 2 years after LUCAR-20SP infusion (Day 1)]
Incidence of anti-LUCAR-20SP antibody
Time frame: Minimum 2 years after LUCAR-20SP infusion (Day 1)
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 25 Mar 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 Phase 1 study testing LUCAR-20SP cells in people with Relapsed B-cell Non-Hodgkin Lymphoma and Refractory B-cell Non-Hodgkin Lymphoma, run by Peking University Cancer Hospital & Institute 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 8 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: looking for participants now, as of the sponsor's last update on 25 Mar 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?
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 Yuqin Song (13683398726, songyq22622@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (DLT) rate (time frame: Minimum 2 years after LUCAR-20SP infusion (Day 1)). The study lists 5 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 25 Mar 2025.