B-Cell LeukemiaPhase 1/2NCT02963038
CAR T Cells for Refractory B Cell Malignancy
A Phase 1/2 study testing Autologous CD19-targeting CAR T cells in people with B-Cell Leukemia and B-Cell Lymphoma, run by Hebei Senlang Biotechnology Inc., Ltd. at 1 site in China.
Trial summary
Chimeric antigen receptor (CAR) T cells targeting CD19 will be evaluated for safety and efficacy in patients with B cell malignancy including lymphoma or leukemia. Read more about this study
- Who is it for?
- Ages 1 year to 70 years
- Conditions the study is for
- B-Cell Leukemia, B-Cell Lymphoma
- What is being tested?
- Autologous CD19-targeting CAR T cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- Jun 2016to Jun 2021
- 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 1 year to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The treat history meeting the following criteria:
- Recurrence of lymphoma patients with imaging (CT/MRI/PET-CT) detection and pathological diagnosis, or recurrence including bone marrow morphology relapse and the MRD recurrence of myeloma patients or leukemia patients, after chemotherapy or stem cell transplantation;
- Can't get complete remission (including MRD positive) after more than twice repeated chemotherapy of incipient lymphoma, myeloma or leukemia patients;
- One or twice chemotherapy cannot get remission again (including MRD positive), but not suitable for chemotherapy of incipient lymphoma, myeloma or leukemia patients.
- There is a measurable lesions before treatment at least;
- ECOG score≤2;
- To be aged 1 to 70 years;
- More than a month lifetime from the consent signing date
Who cannot join
- Serious cardiac insufficiency, left ventricular ejection fraction<50;
- Has a history of severe pulmonary function damaging;
- Merging other malignant tumor;
- Merging uncontrolled infection;
- Merging the metabolic diseases (except diabetes);
- Merging severe autoimmune diseases or immunodeficiency disease;
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- patients with active hepatitis B or hepatitis C;
- patients with HIV infection;
- Has a history of serious allergies on Biological products (including antibiotics);
- Happened in 3 ~ 4 acute GvHD after allogeneic hematopoietic stem cell transplantation on recurring patients Pregnancy or lactation women; Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.
Trial locations and contacts
1 site in 1 country.
Jianmin Luo, PhD & MD contact
China1 site, 1 recruiting
- Recruiting
No.2 Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
Jianqiang Li, PhD & MD, +86311-89928689, limmune@gmail.com
Jianmin Luo, PhD & MD, +86311-66002304
About this study
Official title: Autologous CD19-targeting CAR T Cells for Refractory B Cell Malignancy
Chimeric antigen receptor (CAR) T cells targeting CD19 will be evaluated for safety and efficacy in patients with B cell malignancy including lymphoma or leukemia.
Read the detailed description
The CAR consists of a CD19 targeting antibody scFv with three intracellular signaling domains derived from CD3 zeta, CD28 and 4-1BB. Autologous T cells will be gene engineered with the CAR gene using a lentivirus vector. Prior to T cell infusion, the patients will be subjected to preconditioning treatment. After T cell infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of CAR T cells and efficacy.
- Conditions
- B-Cell Leukemia, B-Cell Lymphoma
- Being tested
- Autologous CD19-targeting CAR T cells
- Medical subject headings
- Leukemia, B-Cell, Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous CD19-targeting CAR T cellsBiological
Autologous CD19-targeting CAR T cells with three signaling domains derived from CD3zeta, CD28 and 4-1BB.
| Study group | Role | What they receive |
|---|---|---|
| CD19 CAR T cells | Experimental | Autologous CD19-targeting CAR T cells Receives: Biological: Autologous CD19-targeting CAR T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor load
Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis.
Measured: Up to 24 months
Secondary outcomes (1)
CAR T cell persistence
Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2017 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-Cell LeukemiaStudies 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Senlang Biotechnology Inc., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Second Hospital of Hebei Medical University
- Responsible party
- Sponsor
- Investigators
- Jianmin Luo, PhD & MD, Principal investigator, The Second Hospital of Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02963038
- Sponsor's protocol ID
- SenL_19
- Status last verified
- Nov 2016
- First submitted
- 28 Oct 2016
- Last updated
- 28 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous CD19-targeting CAR T Cells for Refractory B Cell Malignancy
- ClinicalTrials.gov ID
- NCT02963038
- Acronym / sponsor ID
- SenL_19
- Conditions
- B-Cell Leukemia, B-Cell Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hebei Senlang Biotechnology Inc., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- The Second Hospital of Hebei Medical University
- Study start
- Jun 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 15 Nov 2016 (estimated)
- 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.
Chimeric antigen receptor (CAR) T cells targeting CD19 will be evaluated for safety and efficacy in patients with B cell malignancy including lymphoma or leukemia.
Detailed description
The CAR consists of a CD19 targeting antibody scFv with three intracellular signaling domains derived from CD3 zeta, CD28 and 4-1BB. Autologous T cells will be gene engineered with the CAR gene using a lentivirus vector. Prior to T cell infusion, the patients will be subjected to preconditioning treatment. After T cell infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of CAR T cells and efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CD19 CAR T cells | Experimental | Biological: Autologous CD19-targeting CAR T cellsAutologous CD19-targeting CAR T cells |
Who may qualify
- Ages
- 1 year to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- The treat history meeting the following criteria:
- There is a measurable lesions before treatment at least;
- ECOG score≤2;
- To be aged 1 to 70 years;
- More than a month lifetime from the consent signing date
Key exclusion criteria (10 listed)
- Serious cardiac insufficiency, left ventricular ejection fraction<50;
- Has a history of severe pulmonary function damaging;
- Merging other malignant tumor;
- Merging uncontrolled infection;
- Merging the metabolic diseases (except diabetes);
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 |
|---|---|---|
| Autologous CD19-targeting CAR T cellsAutologous CD19-targeting CAR T cells with three signaling domains derived from CD3zeta, CD28 and 4-1BB. | Biological | CD19 CAR T cells |
Primary outcome
Tumor load
Time frame: Up to 24 months
Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis.
1 secondary outcome
CAR T cell persistence
Time frame: Up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2017.
- 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.
Jianmin Luo, PhD & MD contact
Jianmin Luo, PhD & MD principal investigator
The Second Hospital of Hebei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Autologous CD19-targeting CAR T cells in people with B-Cell Leukemia and B-Cell Lymphoma, run by Hebei Senlang Biotechnology Inc., 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 8 inclusion and 10 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 28 Apr 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 jianqiang li, PhD & MD (+8631189928689, limmune@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor load (time frame: Up to 24 months). 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 28 Apr 2017.