B-Cell Non-Hodgkin Lymphoma-RecurrentPhase 1NCT06395870
Targeting CD19/CD20 Dual-targeted Cell in Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
A Phase 1 study testing LUCAR-G39D cells product in people with B-Cell Non-Hodgkin Lymphoma-Recurrent and B-Cell Non-Hodgkin Lymphoma-Refractory, run by Tianjin Medical University Cancer Institute and Hospital at 2 sites in China.
Trial summary
A phase I, open-label clinical study to evaluate the safety, tolerability, and efficacy of LUCAR-G39D, 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-G39D cells product
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 2 sitesChina
- Study dates
- 9 May 2024to 30 Jun 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 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:
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- 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:
- 1. Prior antitumor therapy with insufficient washout period ; 2. Patients who received autologous CAR-T cell therapy (except CD19-targeted) or autologous gene therapy; 3. 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-G39D CAR-T cell or its excipients, including DMSO.
- 7. Pregnant or lactating women;
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Oncology Department, The First Affiliated Hospital of USTC west district
Hefei, Anhui, 230000
Kaiyang Ding, 13966672170, dingkaiy@126.com
- Recruiting
Tianjin Cancer Hospital
Tianjin, 300060
Huilai Zhang, MD, +86-18622221228, huilaizhangtz@163.com
About this study
Official title: A Phase I, Open-label Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of LUCAR-G39D, 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-G39D, 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-G39D 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-G39D injection. The study will include the following sequential phases: screening, pre-treatment (lymphodepleting chemotherapy), treatment, and follow-up.
- Being tested
- LUCAR-G39D cells product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LUCAR-G39D cells productBiological
Prior to infusion of the LUCAR-G39D, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine.
| Study group | Role | What they receive |
|---|---|---|
| LUCAR-G39D cells product | Experimental | Each subject will be given a single-dose LUCAR-G39D cells infusion at each dose level. Receives: Biological: LUCAR-G39D 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: Through study completion , an average of 2 years after LUCAR-G39D infusion (Day 1)
Pharmacokinetics in peripheral blood
CAR positive T cells and CAR transgene levels in peripheral blood after LUCAR-G39D infusion.
Measured: Through study completion , an average of 2 years after LUCAR-G39D infusion (Day 1).
Pharmacokinetics in bone marrow
CAR positive T cells and CAR transgene levels in bone marrow after LUCAR-G39D infusion.
Measured: Through study completion , an average of 2 years after LUCAR-G39D 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-G39D 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-G39D cell infusion
Measured: Through study completion, an average of 2 years after LUCAR-G39D infusion (Day 1)
Progression-free survival (PFS)
Progression Free Survival (PFS) is defined as the time from the date of first infusion of the LUCAR-G39D 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-G39D infusion (Day 1)
Overall Survival (OS)
Overall Survival (OS) is defined as the time from the date of first infusion of LUCAR-G39D to death of the subject
Measured: Through study completion, an average of 2 years after LUCAR-G39D infusion (Day 1)
Time to Response (TTR)
Time to Response (TTR) is defined as the time from the date of first infusion of LUCAR-G39D 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-G39D 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-G39D infusion (Day 1)
Immunogenicity assessment of LUCAR-G39D cells
The incidence of Anti- LUCAR-G39D antibody in patients who received LUCAR-G39D cells infusion
Measured: Through study completion, an average of 2 years after LUCAR-G39D 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 posted2 May 2024
- Study start9 May 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 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-RecurrentStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe 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
- 33 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Nanjing Legend Biotech Co.
- Responsible party
- Principal investigator, Huilai Zhang, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06395870
- Sponsor's protocol ID
- LB2303-0001
- Status last verified
- May 2024
- First submitted
- 29 Apr 2024
- Last updated
- 6 Nov 2024
- 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 6 Nov 2024. 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-G39D, a Dual-targeted Cell Preparation Targeting CD19/CD20, in Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT06395870
- Acronym / sponsor ID
- LB2303-0001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Collaborators
- Nanjing Legend Biotech Co.
- Study start
- 9 May 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 2 May 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-G39D, 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-G39D 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-G39D 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-G39D cells product | Experimental | Biological: LUCAR-G39D cells productEach subject will be given a single-dose LUCAR-G39D 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 (4 listed)
- 1. Prior antitumor therapy with insufficient washout period ; 2. Patients who received autologous CAR-T cell therapy (except CD19-targeted) or autologous gene therapy; 3. 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-G39D 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-G39D cells productPrior to infusion of the LUCAR-G39D, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine. | Biological | LUCAR-G39D cells product |
Primary outcome
Incidence, severity and type of TEAEs (Treatment-emergent Adverse Events)
Time frame: Through study completion , an average of 2 years after LUCAR-G39D 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: Through study completion , an average of 2 years after LUCAR-G39D infusion (Day 1).
CAR positive T cells and CAR transgene levels in peripheral blood after LUCAR-G39D infusion.
Pharmacokinetics in bone marrow
Time frame: Through study completion , an average of 2 years after LUCAR-G39D infusion (Day 1)
CAR positive T cells and CAR transgene levels in bone marrow after LUCAR-G39D infusion.
The recommended Phase II dose (RP2D) for this cell therapy
Time frame: Within 30 days after LUCAR-G39D 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-G39D infusion (Day 1)
Progression-free survival (PFS)
Time frame: Through study completion, an average of 2 years after LUCAR-G39D infusion (Day 1)
Overall Survival (OS)
Time frame: Through study completion, an average of 2 years after LUCAR-G39D infusion (Day 1)
Time to Response (TTR)
Time frame: Through study completion, an average of 2 years after LUCAR-G39D infusion (Day 1)
Duration of Response (DoR)
Time frame: Through study completion, an average of 2 years after LUCAR-G39D infusion (Day 1)
Immunogenicity assessment of LUCAR-G39D cells
Time frame: Through study completion, an average of 2 years after LUCAR-G39D 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 6 Nov 2024.
- 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.
2 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-G39D cells product in people with B-Cell Non-Hodgkin Lymphoma-Recurrent and B-Cell Non-Hodgkin Lymphoma-Refractory, run by Tianjin Medical University Cancer Institute and Hospital at 2 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 4 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 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 Huilai Zhang (+86-18622221228, huilaizhangtz@163.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: Through study completion , an average of 2 years after LUCAR-G39D 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 6 Nov 2024.