B Cell LymphomaPhase 2NCT03929107
Interleukin-7 and Chemokine (C-C Motif) Ligand 19-expressing CD19-CAR-T for Refractory/Relapsed B Cell Lymphoma.
A Phase 2 study testing Interleukin-7 and Chemokine (C-C Motif) Ligand 19-expressing CD19-CAR-T cells in people with B Cell Lymphoma, run by Wenbin Qian at 1 site in China.
Trial summary
It's a single arm, open label prospective study, in which the safety and efficacy of Interleukin-7 and Chemokine (C-C Motif) Ligand 19-expressing CD19-CAR-T therapy are evaluated in refractory/relapsed B cell lymphoma patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- B Cell Lymphoma
- What is being tested?
- Interleukin-7 and Chemokine (C-C Motif) Ligand 19-expressing CD19-CAR-T cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 28 Mar 2019to 30 Apr 2022
- Phase
- Phase 2
- 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
- 1. Age 18-75 years old, male or female;
- 2. ECOG 0-3, for patients with ECOG=4, if ECOG reach 0-3 after bridging treatment with ibrutinib, they are also considered to fit this criteria;
- 3. Histologically diagnosed as B cell non-Hodgkin's lymphoma (NHL)(according to WHO 2008 criteria), including DLBCL-NOS, primary mediastinal B cell lymphoma (PMBCL) mantel cell lymphoma (MCL), transformed follicular lymphoma (TFL) and other transformed B cell NHL;
- 4. CD19 positive (by immuno-histology or flowcytometry) [for DLBCL/PMBCL/TFL patients, negative CD19 immuno-histology results also acceptable];
- 5. Definition of relapsed and refractory disease: 1) refractory DLBCL should fit one of the following: ①complete remission NOT achieved after 2nd line treatment; ②progression of disease during treatment; ③duration of stable disease <6 months; ④ disease progress or relapse within 12 months of autologous stem cell transplantation.
- 2) definition of refractory/relapsed disease for CLL and other indolent B cell NHL, should fit one of the following: ① failed or relapsed after 2nd therapy (Rituximab must be included) and being unable to accept ibrutinib treatment due to various reasons; ② non-responsive or intolerable to ibrutinib as 2nd line treatment; 3) refractory or relapsed MCL should fit one of the following: ① complete remission not achieved after 2nd line treatment; ② disease progression during treatment; ③duration of stable disease ≤6 months; ④disease progress or relapse within 12 months of autologous stem cell transplantation.
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- 6. Previous treatment of aggressive B lymphomas must include Rituximab and anthracyclines;
- 7. Patients should have at least one measurable disease focus, with the longitudinal diameter ≥1.5cm, or any extra-nodal focus with the longitudinal diameter ≥1.0cm, with PET/CT positive results;
- 8. Blood routine test, absolute neutrophil count≥1000/ul、platelet count≥45000/ul；
- 9. Cardiac, hepatic and renal function: Creatinin <1.5 times of normal maximum；ALT/AST level <2.5 times of the maximum of normal range; total bilirubin<1.5 times of ULN；cardiac ejection fraction≥ 50%;
- 10. Patients should have the ability to fully understand contents of the written consent and be willing to sign the written consent;
- 11. Fertile patients should agree to take contraceptive measures during the process of this trial.
Who cannot join
- 1. History of other malignant tumor;
- 2. History of autologous stem cell transplantation within 6 weeks prior to enrollment;
- 3. Received CAR-T therapy within 3 months prior to enrollment;
- 4. Received cytotoxic medicine or glucocorticoids or other targeted-therapy medicine (except for ibrutinib) within 2 weeks prior to T cell collection;
- 5. With active autoimmune disease;
- 6. With active infection;
- 7. With HIV infection, or uncontrolled HBV/HCV/syphilis infection;
- 8. With known central nervous system lymphoma.
Trial locations and contacts
1 site in 1 country.
Hui Liu, MD,PhD contact
China1 site, 1 recruiting
- Recruiting
The first affiliated hospital of Zhejiang University
Hangzhou, Zhejiang, 310000
Wenbin Qian, MD,PhD, (+86)13605801032, qianwenb@aliyun.com
About this study
Official title: Interleukin-7 and Chemokine (C-C Motif) -Ligand 19-expressing CD19-CAR-T for Refractory/Relapsed B Cell Lymphoma
It's a single arm, open label prospective study, in which the safety and efficacy of Interleukin-7 and Chemokine (C-C Motif) Ligand 19-expressing CD19-CAR-T therapy are evaluated in refractory/relapsed B cell lymphoma patients.
- Conditions
- B Cell Lymphoma
- Being tested
- Interleukin-7 and Chemokine (C-C Motif) Ligand 19-expressing CD19-CAR-T cells
- Keywords
- interleukin 7, Chemokine (C-C Motif) Ligand 19, CAR-T
- 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.
Interleukin-7 and Chemokine (C-C Motif) Ligand 19-expressing CD19-CAR-T cellsBiological
patient's T cells were seperated and engineered into Interleukin-7 and Chemokine (C-C Motif) Ligand 19-expressing CD19-CAR-T cells, and retransfused into the patient for treatment of their B cell lymphoma.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | In this group, patients will be treated with Interleukin-7 and Chemokine (C-C Motif) Ligand 19-expressing CD19-CAR-T, and the safety and efficacy will be evaluated. Receives: Biological: Interleukin-7 and Chemokine (C-C Motif) Ligand 19-expressing CD19-CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete remission rate
complete remission rate after treated by CAR-T therapy
Measured: at the time point 3 months after CAR-T cell transfusion
adverse events
any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure
Measured: from the date of the start of treatment to 24 months after last patient's enrollment
Secondary outcomes (3)
progression free surviva
from date of inclusion to date of progression, relapse, or death from any cause
Measured: from the day of treatment to the date of first documented progression，up to 24 months after the last patient's enrollment
overall survival
from the date of inclusion to date of death, irrespective of cause
Measured: from the day of treatment to the date of first documented progression，up to 24 months after the last patient's enrollment
duration of the CAR-T cells in the patients
time from re-transfusion to date when the modified T cells become non-detectable.
Measured: from the date of re-transfusison to 24 months after last patient's enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2019
- Study start28 Mar 2019
- Primary completion31 Jan 2022 (estimated)
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B Cell LymphomaStudies 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wenbin Qian
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang Provincial Tongde Hospital
- Responsible party
- Sponsor-investigator, Wenbin Qian, First Affiliated Hospital of Zhejiang University
- Investigators
- Wenbin Qian, MD，PhD, Principal investigator, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03929107
- Sponsor's protocol ID
- lymphoma center Q003
- Status last verified
- Apr 2019
- First submitted
- 22 Apr 2019
- Last updated
- 26 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interleukin-7 and Chemokine (C-C Motif) -Ligand 19-expressing CD19-CAR-T for Refractory/Relapsed B Cell Lymphoma
- ClinicalTrials.gov ID
- NCT03929107
- Acronym / sponsor ID
- lymphoma center Q003
- Conditions
- B Cell Lymphoma
- Keywords
- interleukin 7, Chemokine (C-C Motif) Ligand 19, CAR-T
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Wenbin QianUniversity, hospital or other
- Collaborators
- Zhejiang Provincial Tongde Hospital
- Study start
- 28 Mar 2019 (actual)
- Primary completion
- 31 Jan 2022 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 26 Apr 2019 (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.
It's a single arm, open label prospective study, in which the safety and efficacy of Interleukin-7 and Chemokine (C-C Motif) Ligand 19-expressing CD19-CAR-T therapy are evaluated in refractory/relapsed B cell lymphoma patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Biological: Interleukin-7 and Chemokine (C-C Motif) Ligand 19-expressing CD19-CAR-T cellsIn this group, patients will be treated with Interleukin-7 and Chemokine (C-C Motif) Ligand 19-expressing CD19-CAR-T, and the safety and efficacy will be evaluated. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 1. Age 18-75 years old, male or female;
- 2. ECOG 0-3, for patients with ECOG=4, if ECOG reach 0-3 after bridging treatment with ibrutinib, they are also considered to fit this criteria;
- 3. Histologically diagnosed as B cell non-Hodgkin's lymphoma (NHL)(according to WHO 2008 criteria), including DLBCL-NOS, primary mediastinal B cell lymphoma (PMBCL) mantel cell lymphoma (MCL), transformed follicular lymphoma (TFL) and other transformed B cell NHL;
- 4. CD19 positive (by immuno-histology or flowcytometry) [for DLBCL/PMBCL/TFL patients, negative CD19 immuno-histology results also acceptable];
- 5. Definition of relapsed and refractory disease: 1) refractory DLBCL should fit one of the following: ①complete remission NOT achieved after 2nd line treatment; ②progression of disease during treatment; ③duration of stable disease <6 months; ④ disease progress or relapse within 12 months of autologous stem cell transplantation.
Key exclusion criteria (8 listed)
- 1. History of other malignant tumor;
- 2. History of autologous stem cell transplantation within 6 weeks prior to enrollment;
- 3. Received CAR-T therapy within 3 months prior to enrollment;
- 4. Received cytotoxic medicine or glucocorticoids or other targeted-therapy medicine (except for ibrutinib) within 2 weeks prior to T cell collection;
- 5. With active autoimmune disease;
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 |
|---|---|---|
| Interleukin-7 and Chemokine (C-C Motif) Ligand 19-expressing CD19-CAR-T cellspatient's T cells were seperated and engineered into Interleukin-7 and Chemokine (C-C Motif) Ligand 19-expressing CD19-CAR-T cells, and retransfused into the patient for treatment of their B cell lymphoma. | Biological | Intervention group |
Primary outcome
complete remission rate
Time frame: at the time point 3 months after CAR-T cell transfusion
complete remission rate after treated by CAR-T therapy
adverse events
Time frame: from the date of the start of treatment to 24 months after last patient's enrollment
any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure
3 secondary outcomes
progression free surviva
Time frame: from the day of treatment to the date of first documented progression，up to 24 months after the last patient's enrollment
overall survival
Time frame: from the day of treatment to the date of first documented progression，up to 24 months after the last patient's enrollment
duration of the CAR-T cells in the patients
Time frame: from the date of re-transfusison to 24 months after last patient's enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2019.
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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.
Hui Liu, MD,PhD contact
Wenbin Qian, MD，PhD principal investigator
Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Interleukin-7 and Chemokine (C-C Motif) Ligand 19-expressing CD19-CAR-T cells in people with B Cell Lymphoma, run by Wenbin Qian 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 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: status not confirmed, as of the sponsor's last update on 26 Apr 2019. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juying Wei, MD ((+86)13867476302, weijuy@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete remission rate (time frame: at the time point 3 months after CAR-T cell transfusion). 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 26 Apr 2019.