LymphomaNCT03488160
CAR-T Treatment for Relapse / Refractory Type Safety and Effectiveness of Lymphoma
A study testing CD19-targeted CAR-T cells in people with Lymphoma, run by Sinobioway Cell Therapy Co., Ltd. at 1 site in China.
Trial summary
The safety and feasibility of CAR-T cells (CD19.CAR-T) targeted at CD19 in the treatment of relapsed / refractory CD19 positive lymphoma were determined, and the proliferation and survival time of CD19.CAR-T cells in patients were determined. Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- CD19-targeted CAR-T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2018to 20 Apr 2019
- Phase
- Interventional
- 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 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age is 16 years old, less than 70 years old, sex is not limited, race is not limited;
- The pathological diagnosis was CD19 positive expression of B type lymphoma relapsed / refractory, meet any one of the following can be diagnosed with relapsed / refractory lymphoma: 1）the standard scheme of standardized treatment of more than 4 courses in 50%, or the condition of tumor size;2） standard treatment of CR, but the recurrence of use the original scheme or the current national consensus recommended second-line treatment can not get CR again;3） the relapse after haematopoietic stem cell transplantation;
- The patient needs to have a lesion that can be used to detect or evaluate the disease.
- 0~1 score of physical status score of the eastern cancer cooperation group (ECOG).
- At the time of collection of peripheral white blood cell counts over 1 * 10^9/L;
- Expected survival time > 90 days;
- Patients have the ability to know and sign informed consent.
Who cannot join
- Pregnant or lactating women;
- Uncontrolled infection;
- HIV infected people, hepatitis B or HCV active stage;
- Needs patients with long-term immunosuppressive therapy (such as allergies, autoimmune diseases, GVHD, etc.).
- Combined with active central nervous system malignant tumor invading;
- Has abnormal coagulation function, and there are patients with serious thrombus.
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- Organ failure (Appendix); A. heart: Grade II and above; B. liver: higher than grade II; C. kidney: second stages of renal insufficiency and above; D. lung: the second grade was slightly hypofunction and above. E. brain: metastatic or active lesion of the central nervous system.
- Patients who participated in other clinical trials in the past 30 days or in other clinical trials;
- Researchers believe that patients are not suitable for the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The west area of the First Affiliated Hospital of University of Science & Technology China
Hefei, Anhui, 230000
Guolin Wu, 13855105487, wgldoctor@sina.com
Kaiyang Ding, 13966672170, dingkaiy@126.com
About this study
Official title: CAR-T Cell Therapy for Relapsed / Refractory CD19 Positive Clinical Study on the Safety and Effectiveness of Lymphoma
The safety and feasibility of CAR-T cells (CD19.CAR-T) targeted at CD19 in the treatment of relapsed / refractory CD19 positive lymphoma were determined, and the proliferation and survival time of CD19.CAR-T cells in patients were determined.
Read the detailed description
The sponsors of this research also studied CD19.CAR-T cells for the treatment of leukemia and lymphoma, two courses of three transfusion 14 days after infection process standard training program , the safety and effectiveness have accumulated some of the data. In this study, the investigators will regenerate the cultured cells for 2 times in a course of treatment, and enter the patient's body . The investigators observed the safety and efficacy of CAR-T cell therapy.
- Conditions
- Lymphoma
- Being tested
- CD19-targeted CAR-T cells
- Keywords
- lymphoma CAR-T
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD19-targeted CAR-T cellsBiological
This study have only one arm that is CAR-T experimental arm. Firstly all participators will be attended the screening, who passed the screening for the treatment of CAR-T cells, the CAR-CD19-modified T cells can recognize and kill tumor cells in the body，follow-up 35 months..
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | The Chimeric Antigen Receptor T Cell Immunotherapy (CAR-T) Dosage form：injection Dosage:100ml/time Frequency:the first day,the second day Duration:total two times Receives: Biological: CD19-targeted CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure: The overall efficiency
Complete remission (CR) number+The number of partial response (PR)/Total number of cases being treated
Measured: [Time Frame: 3 years]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2018
- Study start10 Apr 2018 (estimated)
- Primary completion10 Apr 2019 (estimated)
- Study completion20 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinobioway Cell Therapy Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guolin Wu, Principal investigator, Investigator associate chief physicianKaiyang Ding, Principal investigator, Chief physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03488160
- Sponsor's protocol ID
- sinobiowayCT
- Status last verified
- Apr 2018
- First submitted
- 26 Mar 2018
- Last updated
- 10 Apr 2018
- 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 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAR-T Cell Therapy for Relapsed / Refractory CD19 Positive Clinical Study on the Safety and Effectiveness of Lymphoma
- ClinicalTrials.gov ID
- NCT03488160
- Acronym / sponsor ID
- sinobiowayCT
- Conditions
- Lymphoma
- Keywords
- lymphoma CAR-T
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Sinobioway Cell Therapy Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Apr 2018 (estimated)
- Primary completion
- 10 Apr 2019 (estimated)
- Study completion
- 20 Apr 2019 (estimated)
- First posted
- 4 Apr 2018 (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.
The safety and feasibility of CAR-T cells (CD19.CAR-T) targeted at CD19 in the treatment of relapsed / refractory CD19 positive lymphoma were determined, and the proliferation and survival time of CD19.CAR-T cells in patients were determined.
Detailed description
The sponsors of this research also studied CD19.CAR-T cells for the treatment of leukemia and lymphoma, two courses of three transfusion 14 days after infection process standard training program , the safety and effectiveness have accumulated some of the data. In this study, the investigators will regenerate the cultured cells for 2 times in a course of treatment, and enter the patient's body . The investigators observed the safety and efficacy of CAR-T cell therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Biological: CD19-targeted CAR-T cellsThe Chimeric Antigen Receptor T Cell Immunotherapy (CAR-T) Dosage form：injection Dosage:100ml/time Frequency:the first day,the second day Duration:total two times |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Age is 16 years old, less than 70 years old, sex is not limited, race is not limited;
- The pathological diagnosis was CD19 positive expression of B type lymphoma relapsed / refractory, meet any one of the following can be diagnosed with relapsed / refractory lymphoma: 1）the standard scheme of standardized treatment of more than 4 courses in 50%, or the condition of tumor size;2） standard treatment of CR, but the recurrence of use the original scheme or the current national consensus recommended second-line treatment can not get CR again;3） the relapse after haematopoietic stem cell transplantation;
- The patient needs to have a lesion that can be used to detect or evaluate the disease.
- 0~1 score of physical status score of the eastern cancer cooperation group (ECOG).
- At the time of collection of peripheral white blood cell counts over 1 * 10^9/L;
Key exclusion criteria (9 listed)
- Pregnant or lactating women;
- Uncontrolled infection;
- HIV infected people, hepatitis B or HCV active stage;
- Needs patients with long-term immunosuppressive therapy (such as allergies, autoimmune diseases, GVHD, etc.).
- Combined with active central nervous system malignant tumor invading;
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 |
|---|---|---|
| CD19-targeted CAR-T cellsThis study have only one arm that is CAR-T experimental arm. Firstly all participators will be attended the screening, who passed the screening for the treatment of CAR-T cells, the CAR-CD19-modified T cells can recognize and kill tumor cells in the body，follow-up 35 months.. | Biological | Single arm |
Primary outcome
Primary Outcome Measure: The overall efficiency
Time frame: [Time Frame: 3 years]
Complete remission (CR) number+The number of partial response (PR)/Total number of cases being treated
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2018.
- 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. This study is not recruiting at the moment.
Guolin Wu principal investigator
Investigator associate chief physician
Kaiyang Ding principal investigator
Chief physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CD19-targeted CAR-T cells in people with Lymphoma, run by Sinobioway Cell Therapy Co., Ltd. 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 7 inclusion and 9 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 10 Apr 2018. 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.
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 Guolin Wu (13855105487, wgldoctor@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome Measure: The overall efficiency (time frame: [Time Frame: 3 years]). 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 10 Apr 2018.