B Cell LymphomaPhase 1/2NCT03146533
CD19 CART Cells for Patients With Relapse and Refractory CD19+ B-cell Lymphoma.
A Phase 1/2 study testing Fludarabine, Cyclophosphamide and CD19 CART in people with B Cell Lymphoma, run by Shenzhen Second People's Hospital at 1 site in China.
Trial summary
This is a clinical study to observe the maximum tolerated dose (MTD) and the safety and feasibility of chimeric antigen receptor 19 (CD19 CART) cells in relapsed and refractory patients with CD19+ B cell lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- B Cell Lymphoma
- What is being tested?
- Fludarabine, Cyclophosphamide and CD19 CART
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- May 2017to Oct 2019
- Phase
- Phase 1/2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. 18 years to 70 years, expected survival > 3 months;
- 2. CD19 positive B-cell lymphoma;
- 3. KPS >80;
- 4. Having at least one measurable lesions;
- 5. Cardiac function: 1-2 levels; Liver: TBIL≤3ULN，AST ≤2.5ULN，ALT ≤2.5ULN; kidney: Cr≤1.25ULN; bone marrow: WBC ≥ 3.0×109/L, Hb ≥90 g/L, PLT ≥ 80×109/L）;
- 6. No serious allergic constitution;
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- 7. No other serous diseases that conflicts with the clinical program;
- 8. No other cancer history;
- 9. No serious mental disorder;
- 10. Informed consent is signed by a subject or his lineal relation.
Who cannot join
- 1. Pregnant or lactating women; (female participants of reproductive potential must have a negative serum or urine pregnancy test);
- 2. Uncontrolled active infection, HIV infection, syphilis serology reaction positive;
- 3. Active hepatitis B or hepatitis C infection;
- 4. Recent or current use of glucocorticoid or other immunosuppressor;
- 5. With severe cardiac, liver, renal insufficiency, diabetes and other diseases;
- 6. Transaminase >2.5ULN, Bilirubin >3ULN，Creatinine>1.25ULN
- 7. Participate in other clinical research in the past three months; previously treatment with any gene therapy products;
- 8. Researchers think of that does not fit to participate in the study, or other cases that affect the clinical trial results;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second People's Hospital of Shenzhen
Shenzhen, Guangdong
geng tian, 13724395569, tiangeng666@aliyun.com
geng tian
About this study
Official title: Phase I/II Study of CD19 CART Cells for Patients With Relapse and Refractory CD19+ B-cell Lymphoma.
This is a clinical study to observe the maximum tolerated dose (MTD) and the safety and feasibility of chimeric antigen receptor 19 (CD19 CART) cells in relapsed and refractory patients with CD19+ B cell lymphoma.
Read the detailed description
This is a study for the patients with B cell lymphoma. Maximum tolerated dose climbing test is expected into the group of 9 cases of patients. And Phase II expected into the group of 11 subjects, selected the above safe dose, carrying out a research into the clinical effectiveness. Subjects will be collected their T cells and modify them, the modification is a genetic change, that CD19:4-1BB:CD28:CD3 modified T cells, in order to tells the T cells to recognize their target tumor cells and potentially kill them, but not other normal cells in the subject's body. The CART cells will then be expanded in vitro and then administered to subjects. The purpose of this study is observe the MTD and to assess the safety and feasibility of CART cells in the patients with relapsed and refractory CD19+ B cell lymphoma.
- Conditions
- B Cell Lymphoma
- Being tested
- Fludarabine, Cyclophosphamide, CD19 CART
- 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.
FludarabineDrug
Fludarabine 30 mg/m2/day IV for 3 days.
CyclophosphamideDrug
patients will receive a standard pre-conditioning regime with cyclophosphamide 0.8g/m2/day IV for 2 days.
CD19 CARTBiological
CD19 CART cells will be administered using a split dose on day0(10%), 1(30%), and 2(60%) after completion of the chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| CD19 CART | Experimental | patients will receive a pre-conditioning with cyclophosphamide and fludarabine before infusion of CD19 CART cells. The CD19 CART cells are to be administered on day0,day1,day2. Receives: Drug: Fludarabine; Drug: Cyclophosphamide; Biological: CD19 CART |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety as assessed by the occurence of study related adverse events
monitor the occurence of study related adverse events
Measured: 6 months
observe the maximum tolerated dose (MTD)
Measured: 2 months
objective response rate
CR+PR
Measured: 2 years
disease control rate
CR+PR+SD
Measured: 2 years
overall survival
OS
Measured: 2 years
Progression-Free Survival
Measured: 2 years
Secondary outcomes (3)
Determine duration of in vivo survival of CD19 CART cells
CD19 CART vector sequences will be performed by Q-PCR
Measured: 2 years
Peripheral blood cytokines
IL-6、IL-10、IFN-γ、TNF-α
Measured: 2 months
subgroup of T cell
CD3、CD4、CD8
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study startMay 2017 (estimated)
- Primary completionApr 2019 (estimated)
- Study completionOct 2019 (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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Second People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Beijing Pregene Science and Technology Company, Ltd.
- Responsible party
- Sponsor
- Investigators
- geng tian, Principal investigator, Shenzhen Second People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03146533
- Sponsor's protocol ID
- FirstShenzhen01
- Status last verified
- Apr 2017
- First submitted
- 7 May 2017
- Last updated
- 17 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of CD19 CART Cells for Patients With Relapse and Refractory CD19+ B-cell Lymphoma.
- ClinicalTrials.gov ID
- NCT03146533
- Acronym / sponsor ID
- FirstShenzhen01
- Conditions
- B Cell Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shenzhen Second People's HospitalUniversity, hospital or other
- Collaborators
- The Beijing Pregene Science and Technology Company, Ltd.
- Study start
- May 2017 (estimated)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 10 May 2017 (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 clinical study to observe the maximum tolerated dose (MTD) and the safety and feasibility of chimeric antigen receptor 19 (CD19 CART) cells in relapsed and refractory patients with CD19+ B cell lymphoma.
Detailed description
This is a study for the patients with B cell lymphoma. Maximum tolerated dose climbing test is expected into the group of 9 cases of patients. And Phase II expected into the group of 11 subjects, selected the above safe dose, carrying out a research into the clinical effectiveness. Subjects will be collected their T cells and modify them, the modification is a genetic change, that CD19:4-1BB:CD28:CD3 modified T cells, in order to tells the T cells to recognize their target tumor cells and potentially kill them, but not other normal cells in the subject's body. The CART cells will then be expanded in vitro and then administered to subjects. The purpose of this study is observe the MTD and to assess the safety and feasibility of CART cells in the patients with relapsed and refractory CD19+ B cell lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CD19 CART | Experimental | Drug: Fludarabine, Drug: Cyclophosphamide, Biological: CD19 CARTpatients will receive a pre-conditioning with cyclophosphamide and fludarabine before infusion of CD19 CART cells. The CD19 CART cells are to be administered on day0,day1,day2. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 1. 18 years to 70 years, expected survival > 3 months;
- 2. CD19 positive B-cell lymphoma;
- 3. KPS >80;
- 4. Having at least one measurable lesions;
- 5. Cardiac function: 1-2 levels; Liver: TBIL≤3ULN，AST ≤2.5ULN，ALT ≤2.5ULN; kidney: Cr≤1.25ULN; bone marrow: WBC ≥ 3.0×109/L, Hb ≥90 g/L, PLT ≥ 80×109/L）;
Key exclusion criteria (8 listed)
- 1. Pregnant or lactating women; (female participants of reproductive potential must have a negative serum or urine pregnancy test);
- 2. Uncontrolled active infection, HIV infection, syphilis serology reaction positive;
- 3. Active hepatitis B or hepatitis C infection;
- 4. Recent or current use of glucocorticoid or other immunosuppressor;
- 5. With severe cardiac, liver, renal insufficiency, diabetes and other diseases;
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 |
|---|---|---|
| FludarabineFludarabine 30 mg/m2/day IV for 3 days. | Drug | CD19 CART |
| Cyclophosphamidepatients will receive a standard pre-conditioning regime with cyclophosphamide 0.8g/m2/day IV for 2 days. | Drug | CD19 CART |
| CD19 CARTCD19 CART cells will be administered using a split dose on day0(10%), 1(30%), and 2(60%) after completion of the chemotherapy. | Biological | CD19 CART |
Primary outcome
safety as assessed by the occurence of study related adverse events
Time frame: 6 months
monitor the occurence of study related adverse events
observe the maximum tolerated dose (MTD)
Time frame: 2 months
objective response rate
Time frame: 2 years
CR+PR
disease control rate
Time frame: 2 years
CR+PR+SD
overall survival
Time frame: 2 years
OS
Progression-Free Survival
Time frame: 2 years
3 secondary outcomes
Determine duration of in vivo survival of CD19 CART cells
Time frame: 2 years
Peripheral blood cytokines
Time frame: 2 months
subgroup of T cell
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
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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.
geng tian principal investigator
Shenzhen Second People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Fludarabine, Cyclophosphamide and CD19 CART in people with B Cell Lymphoma, run by Shenzhen Second People's Hospital 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 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 17 May 2017. 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 combined 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.
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 geng tian (13724395569, tiangeng666@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety as assessed by the occurence of study related adverse events (time frame: 6 months). The study lists 6 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 17 May 2017.