Lymphoma, B-CellNCT03564977
CD19-targeted CAR-T Cell Therapy for MRD+ B-cell Malignancies After Autologous Stem Cell Transplantation
A study testing CD19-targeted CAR-T cells in people with Lymphoma, B-Cell and Leukemia, B-Cell, run by Qingdao Central Hospital at 1 site in China.
Trial summary
The main purpose of this study is to explore the efficacy of CD19-targeted CAR-T cell therapy for minimal residual disease (MRD) in B-cell Malignancies after autologous stem cell transplantation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lymphoma, B-Cell, Leukemia, B-Cell, Minimal Disease, Residual
- What is being tested?
- CD19-targeted CAR-T cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2018to 15 Jun 2020
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed by pathological biopsy in patients with B-cell malignancies and treated by autologous stem cell transplantation.
- Age 18 to 75 years old, both male and female;
- Is expected to survive more than 3 months;
- Physical condition is good: ECOG score≤2;
- In group of four weeks before Canon imaging examination evaluation body tumor load, recommend line PET - CT examination.
- General requirements autologous as basic, normal blood T lymphocytes in autologous count must >= 0.2 x10^9 / L;
- No obvious abnormal heart, liver, kidney, no large wounds that haven't healed on the body;
- Into groups to participate in voluntarily, good adherence, can cooperate test observation, childbearing age women must be 7 days before starting treatment expert pregnancy test and the results were negative, and signed a written informed consent form.
Who cannot join
- Organ failure, such as heart: Class III and IV; liver: to Child grading of liver function grade C; kidney: kidney failure and uremia stage; lung: symptoms of severe respiratory failure; brain: disorder of consciousness;
- Existing serious acute infection, uncontrollable, or have fester sex and chronic infection, wound in delay no more;
- Patients with significant graft versus host disease (GVHD) after organ transplant history or allogeneic hematopoietic stem cell transplantation;
- Systemic autoimmune diseases or immunodeficiency disease, patients with allergic constitution;
- Coagulation abnormalities and severe thrombosis;
- Pregnancy and lactation women;
Show all 9Show fewer
- Any other chronic disease patients who have been treated with immune agents or hormone therapy;
- Patients who have participated in other clinical trials or other clinical trials in the past 30 days;
- The Investigator believe the patients should not participate in this experiment.
Trial locations and contacts
1 site in 1 country.
Ketao Lana contact
China1 site, 1 recruiting
- Recruiting
Qingdao Central Hospital
Qingdao, Shandong, 266042
Peng Zhao, Dr, zp8102@126.com
Ling Wang, Dr, wldoctor@126.com
About this study
Official title: CD19-targeted CAR-T Cell Therapy for Minimal Residual Disease in B-cell Malignancies After Autologous Stem Cell Transplantation
The main purpose of this study is to explore the efficacy of CD19-targeted CAR-T cell therapy for minimal residual disease (MRD) in B-cell Malignancies after autologous stem cell transplantation.
Read the detailed description
Relapse is a common cause of failure in patients with B-cell malignancies after autologous stem cell transplantation. CD19-targeted CAR-T cells showed excellent therapeutic efficiency in B-cell malignancies. Investigators attempt to treat minimal residual disease (MRD)-positive B-cell Malignancies after autologous stem cell transplantation by CD19-targeted CAR-T cells and hope to explore the therapeutic effects of CD19-targeted CAR-T cell therapy.
- Being tested
- CD19-targeted CAR-T cells
- Keywords
- CAR-T, minimal residual disease, B cell maliganacy
- Medical subject headings
- Lymphoma, B-Cell, Leukemia, B-Cell, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD19-targeted CAR-T cellsBiological
MDR+ patients after autologous stem cell transplantation were treated with CD19-targeted CAR-T cells.
| Study group | Role | What they receive |
|---|---|---|
| CD19-targeted CAR-T cells | Experimental | Not described Receives: Biological: CD19-targeted CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Measured: 2 years
Disease control rate
Measured: 2 years
Overall survival
Measured: 2 years
Progress-free survival
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 posted21 Jun 2018
- Study start15 Jul 2018 (estimated)
- Primary completion15 Jun 2020 (estimated)
- Study completion15 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, B-CellStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qingdao Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Yake Biotechnology Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03564977
- Sponsor's protocol ID
- QingdaoCH201805
- Status last verified
- Jun 2018
- First submitted
- 11 Jun 2018
- Last updated
- 2 Jul 2018
- 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 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CD19-targeted CAR-T Cell Therapy for Minimal Residual Disease in B-cell Malignancies After Autologous Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT03564977
- Acronym / sponsor ID
- QingdaoCH201805
- Keywords
- CAR-T, minimal residual disease, B cell maliganacy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Qingdao Central HospitalUniversity, hospital or other
- Collaborators
- Yake Biotechnology Ltd.
- Study start
- 15 Jul 2018 (estimated)
- Primary completion
- 15 Jun 2020 (estimated)
- Study completion
- 15 Jun 2020 (estimated)
- First posted
- 21 Jun 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 main purpose of this study is to explore the efficacy of CD19-targeted CAR-T cell therapy for minimal residual disease (MRD) in B-cell Malignancies after autologous stem cell transplantation.
Detailed description
Relapse is a common cause of failure in patients with B-cell malignancies after autologous stem cell transplantation. CD19-targeted CAR-T cells showed excellent therapeutic efficiency in B-cell malignancies. Investigators attempt to treat minimal residual disease (MRD)-positive B-cell Malignancies after autologous stem cell transplantation by CD19-targeted CAR-T cells and hope to explore the therapeutic effects of CD19-targeted 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 |
|---|---|---|
| CD19-targeted CAR-T cells | Experimental | Biological: CD19-targeted CAR-T cells |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Confirmed by pathological biopsy in patients with B-cell malignancies and treated by autologous stem cell transplantation.
- Age 18 to 75 years old, both male and female;
- Is expected to survive more than 3 months;
- Physical condition is good: ECOG score≤2;
- In group of four weeks before Canon imaging examination evaluation body tumor load, recommend line PET - CT examination.
Key exclusion criteria (9 listed)
- Organ failure, such as heart: Class III and IV; liver: to Child grading of liver function grade C; kidney: kidney failure and uremia stage; lung: symptoms of severe respiratory failure; brain: disorder of consciousness;
- Existing serious acute infection, uncontrollable, or have fester sex and chronic infection, wound in delay no more;
- Patients with significant graft versus host disease (GVHD) after organ transplant history or allogeneic hematopoietic stem cell transplantation;
- Systemic autoimmune diseases or immunodeficiency disease, patients with allergic constitution;
- Coagulation abnormalities and severe thrombosis;
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 cellsMDR+ patients after autologous stem cell transplantation were treated with CD19-targeted CAR-T cells. | Biological | CD19-targeted CAR-T cells |
Primary outcome
Objective response rate
Time frame: 2 years
Disease control rate
Time frame: 2 years
Overall survival
Time frame: 2 years
Progress-free survival
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 2 Jul 2018.
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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.
Ketao Lana contact
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, B-Cell and Leukemia, B-Cell, run by Qingdao Central 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 8 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 2 Jul 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 Peng Zhao, doctor (8653284961737, zp8102@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: 2 years). 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 2 Jul 2018.