Diffuse Large B Cell LymphomaPhase 1NCT06517004
An Open-label, Single-arm Study of JWCAR201 in the Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma
A Phase 1 study testing JWCAR201 in people with Diffuse Large B Cell Lymphoma, run by Fudan University at 1 site in China.
Trial summary
This is an open-label, single-arm study to investigate the efficacy and safety signals of JWCAR201 amongst subjects with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B Cell Lymphoma
- What is being tested?
- JWCAR201
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 18 Jul 2024to Aug 2027
- 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
- Age ≥18
- Voluntarily willing to participate in the study and sign the written informed consent form
- Histologically confirmed diffuse large B-cell lymphoma (DLBCL) with immunohistochemistry (IHC) CD20-positive
- Patients must be priorly treated by Anthracyclines and anti-CD20-targeted regimens, and must be refractory or relapsed to at least ≥2 treatment lines of standard of care or autologous hematopoietic stem-cell transplantation (HSCT)
- At least one measurable lesion by CT or PET per Lugano criteria
- Eastern Cooperative Oncology Group (ECOG) performance status scale ≤1
Show all 10Show fewer
- Adequate organ functions
- Adequate venous access for apheresis
- Women of childbearing potential must agree to use an effective and reliable contraceptive method till 1-year post-infusion
- Male patients who have not undergone vasectomy and have sexual activity with women of childbearing potential must agree to the use of a barrier contraceptive till 1-year post-infusion
Who cannot join
- Primary central nervous system lymphoma
- Another primary malignancy within 2 years
- Active infections of hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), or syphilis
- With severe active deep venous thrombosis or pulmonary embolism within 3 months
- Treated with anti-coagulations (except for prophylaxis use) due to severe active deep venous thrombosis or pulmonary embolism within 3 months
- Uncontrolled or active infection
Show all 13Show fewer
- Acute or chronic graft-versus-host disease (GvHD)
- With severe cardiovascular diseases within 6 months
- With severe clinically-significant central nervous system disorders within 6 months
- Pregnant or lactating women
- Not satisfying pre-defined wash-out period for apheresis
- Unable or unwilling to comply with the study protocol, judged by the investigator, or other situations implying that the subject might not be appropriate to participate in the study
- Previously treated with any genetically engineered modified T-cell therapy nor other cell-gene therapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Wenhao Zhang, MD contact
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, 200032
Rong Tao, MD, 8621-64175590, rtao@shca.org.cn
Chuanxu Liu, MD, 8621-64175590, liuchuanxu@shca.org.cn
About this study
This is an open-label, single-arm study to investigate the efficacy and safety signals of JWCAR201 amongst subjects with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
Read the detailed description
This is an open-label, single-arm, investigator-initiated study (IIT) to evaluate the safety an JWCAR201 in adult patients with relapsed/refractory diffuse large B-cell lymphoma (r/r DLBCL). The study employs a two-stage, Continual Reassessment Method (CRM)-like dose escalation design. In the first stage, each dose cohort will use an accelerated titration approach, escalating to the dose level at which a Dose-Limiting Toxicity (DLT) occurs or the 50 × 10^6 CAR+ T-cell dose level (whichever is reached first). The second stage will start at observed DLT dose level or the 50^6 CAR+ T-cell dose level, an model-based CRM method using a single-parameter Logistic model will be used to describe the relationship between the JWCAR201 dose and the probability of observed DLTs. The Maximum Tolerated Dose (MTD) is defined as the highest an estimated DLT probability below the 25% target toxicity level. For each dose level, a prior mean DLT risk (skeleton) will be set based on historical data. After enrolling ≥3 patients perort, the prior DLT risk will be updated based on the available study data, and the DLT risk will be communicated to the Data Safety Monitoring Committee to recommend the next cohort dose. The study plans to start at 25 × 10^6 CAR+ T cells as the initial dose, with exploration across three dose levels (25 × 10^6, 50 × 10^6, 75 × 10^6 CAR+ T cells), and 15 × 10^6 CAR+ T cells or lower and 100 × 10^6 CAR+ T cells or higher as backup doses, aiming to evaluate the safety, tolerability of JWCAR201 in r/r DLBCL and determine the recommended dose for expansion. Additionally, pharmacokinetic and pharmacodynamic characteristics are also study objectives.
- Conditions
- Diffuse Large B Cell Lymphoma
- Being tested
- JWCAR201
- Keywords
- CAR-T therapy, Diffuse Large B Cell Lymphoma
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JWCAR201Biological
Autologous CD19/CD20-directed CAR-T cells, single infusion intravenously
| Study group | Role | What they receive |
|---|---|---|
| JWCAR201 Treatment Arm | Experimental | Patients will be administrated with autologous CD19/CD20-directed CAR-T cells after lymphocyte depletion by fludarabine and cyclophosphamide. Receives: Biological: JWCAR201 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of dose-limiting toxicities (DLTs)
Dose limiting toxicities for each subject
Measured: 28 days
AE/SAE
Incidence and severity of adverse events (AE), and serious adverse event (SAE)
Measured: 24 months
Secondary outcomes (7)
Copy number of the vector transgene of JWCAR201 in peripheral blood
The pharmacokinetic parameters of JWCAR201 will be evaluated by quantitative polymerase chain reaction (qPCR) for the copy number of the vector transgene of JWCAR201 in peripheral blood to evaluate T-cell expansion and persistence.
Measured: 24 months
CD19-positive cells and CD20-positive cells in peripheral blood
CD19-positive cells and CD20-positive cells in peripheral blood will be tested by flow cytometry (FCM).
Measured: 24 months
Objective response rate (ORR)
Proportion of patients whose tumor volume has reached a predetermined value and can maintain a minimum time limit, including complete response and partial response patients.
Measured: 24 months
Complete response rate (CRR)
The percentage of patients with advanced or metastatic cancer who have achieved complete response to a therapeutic intervention in clinical trials of anticancer agents.
Measured: 24 months
Duration of response (DOR)
The time from the date of first response (PR or better) to the date of disease progression or death after JWCAR201 infusion.
Measured: 24 months
Progression-free survival (PFS)
The time from JWCAR201 infusion to the date of progression as assessed by Lugano criteria or death.
Measured: 24 months
Overall survival (OS)
Defined as the time from the date of first infusion of JWCAR201 to death due to any cause.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start18 Jul 2024
- Primary completionDec 2025 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Fudan 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
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rong Tao, Fudan University
- Investigators
- Rong Tao, MD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06517004
- Sponsor's protocol ID
- JWCAR201002
- Status last verified
- Jul 2024
- First submitted
- 18 Jul 2024
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-arm Study of JWCAR201 in the Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT06517004
- Acronym / sponsor ID
- JWCAR201002
- Conditions
- Diffuse Large B Cell Lymphoma
- Keywords
- CAR-T therapy, Diffuse Large B Cell Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 18 Jul 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 24 Jul 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 an open-label, single-arm study to investigate the efficacy and safety signals of JWCAR201 amongst subjects with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
Detailed description
This is an open-label, single-arm, investigator-initiated study (IIT) to evaluate the safety an JWCAR201 in adult patients with relapsed/refractory diffuse large B-cell lymphoma (r/r DLBCL). The study employs a two-stage, Continual Reassessment Method (CRM)-like dose escalation design. In the first stage, each dose cohort will use an accelerated titration approach, escalating to the dose level at which a Dose-Limiting Toxicity (DLT) occurs or the 50 × 10^6 CAR+ T-cell dose level (whichever is reached first). The second stage will start at observed DLT dose level or the 50^6 CAR+ T-cell dose level, an model-based CRM method using a single-parameter Logistic model will be used to describe the relationship between the JWCAR201 dose and the probability of observed DLTs. The Maximum Tolerated Dose (MTD) is defined as the highest an estimated DLT probability below the 25% target toxicity level. For each dose level, a prior mean DLT risk (skeleton) will be set based on historical data. After enrolling ≥3 patients perort, the prior DLT risk will be updated based on the available study data, and the DLT risk will be communicated to the Data Safety Monitoring Committee to recommend the next cohort dose. The study plans to start at 25 × 10^6 CAR+ T cells as the initial dose, with exploration across three dose levels (25 × 10^6, 50 × 10^6, 75 × 10^6 CAR+ T cells), and 15 × 10^6 CAR+ T cells or lower and 100 × 10^6 CAR+ T cells or higher as backup doses, aiming to evaluate the safety, tolerability of JWCAR201 in r/r DLBCL and determine the recommended dose for expansion. Additionally, pharmacokinetic and pharmacodynamic characteristics are also study objectives.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JWCAR201 Treatment Arm | Experimental | Biological: JWCAR201Patients will be administrated with autologous CD19/CD20-directed CAR-T cells after lymphocyte depletion by fludarabine and cyclophosphamide. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥18
- Voluntarily willing to participate in the study and sign the written informed consent form
- Histologically confirmed diffuse large B-cell lymphoma (DLBCL) with immunohistochemistry (IHC) CD20-positive
- Patients must be priorly treated by Anthracyclines and anti-CD20-targeted regimens, and must be refractory or relapsed to at least ≥2 treatment lines of standard of care or autologous hematopoietic stem-cell transplantation (HSCT)
- At least one measurable lesion by CT or PET per Lugano criteria
Key exclusion criteria (13 listed)
- Primary central nervous system lymphoma
- Another primary malignancy within 2 years
- Active infections of hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), or syphilis
- With severe active deep venous thrombosis or pulmonary embolism within 3 months
- Treated with anti-coagulations (except for prophylaxis use) due to severe active deep venous thrombosis or pulmonary embolism within 3 months
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 |
|---|---|---|
| JWCAR201Autologous CD19/CD20-directed CAR-T cells, single infusion intravenously | Biological | JWCAR201 Treatment Arm |
Primary outcome
Rate of dose-limiting toxicities (DLTs)
Time frame: 28 days
Dose limiting toxicities for each subject
AE/SAE
Time frame: 24 months
Incidence and severity of adverse events (AE), and serious adverse event (SAE)
7 secondary outcomes
Copy number of the vector transgene of JWCAR201 in peripheral blood
Time frame: 24 months
CD19-positive cells and CD20-positive cells in peripheral blood
Time frame: 24 months
Objective response rate (ORR)
Time frame: 24 months
Complete response rate (CRR)
Time frame: 24 months
Duration of response (DOR)
Time frame: 24 months
Progression-free survival (PFS)
Time frame: 24 months
Overall survival (OS)
Time frame: 24 months
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 24 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Diffuse Large B Cell Lymphoma
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
Not yet recruitingPhase 2
The CARDIOPROTECT Trial
Diffuse Large B-cell Lymphoma (DLBCL), Cardiotoxicity
Not yet recruitingPhase 2
QLS4131 Plus Isa-V-CHOP in Newly Diagnosed, HIV-Negative PBL: A Single-Center, Single-Arm, Phase II Study
Plasmablastic Lymphoma
RecruitingPhase 2
Testing the Effectiveness of a Combination Targeted Therapy (ViPOR) for Patients With Relapsed and/or Refractory Aggressive B-cell Lymphoma
High Grade B-Cell Lymphoma With MYC and BCL6 Rearrangements, Recurrent Diffuse Large B-Cell Lymphoma
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.
Wenhao Zhang, MD contact
Rong Tao, MD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JWCAR201 in people with Diffuse Large B Cell Lymphoma, run by Fudan University at 1 site 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 10 inclusion and 13 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 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Rong Tao, MD (+8621-64175590, rtao@shca.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of dose-limiting toxicities (DLTs) (time frame: 28 days). The study lists 2 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 24 Jul 2024.