B Cell LymphomaPhase 1/2NCT02547948
CD19-targeting CAR T Cells for B Cell Lymphoma
A Phase 1/2 study testing CD19-targeting CAR T Cells infusion in people with B Cell Lymphoma, run by Fuda Cancer Hospital, Guangzhou at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of CD19-targeting CAR T Cells infusion for B Cell Lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- B Cell Lymphoma
- What is being tested?
- CD19-targeting CAR T Cells infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- Sep 2015to 15 Aug 2016
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Relapsed or refractory CD19+ B-cell lymphoma.
- Measurable disease.
- Performance status ECOG 0-2.
- Age:18-80.
- Fertile females/males must consent to use contraceptives during participation of the trial.
- Signed informed consent
Who cannot join
- Any significant medical or psychiatric illness that would prevent the patient from giving informed consent or from following the study procedures.
- Patients with primary CNS lymphoma.
- Known human immunodeficiency virus (HIV) infection.
- Active and/or severe infection (e.g. tuberculosis, sepsis and opportunistic infections, active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection).
- Other serious underlying medical conditions, which, in the Investigator's judgment, could impair the ability of the patient.
- Treatment with an investigational product within 30 days prior to enrollment, or at least 5 half lives of that drug, which is longest.
- Patients that do not consent to that tissue and blood samples are stored in a biobank.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
China1 site
Central laboratory in Fuda cancer hospital
Guangzhou, Guangdong, 510000
About this study
Official title: CD19-targeting CAR T Cells for Refractory B Cell Lymphoma
The purpose of this study is to evaluate the safety and efficacy of CD19-targeting CAR T Cells infusion for B Cell Lymphoma.
Read the detailed description
Chimeric antigen receptor (CAR) T cells targeting CD19 will be evaluated for safety and efficacy in patients with B cell lymphoma or leukemia. The CAR consists of a CD19 targeting antibody scFv with two intracellular signaling domains derived from CD3 zeta and CD28. Autologous T cells will be gene-engineered with the CAR gene using a retrovirus 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 Lymphoma
- Being tested
- CD19-targeting CAR T Cells infusion
- Keywords
- CD19, CAR T Cells, Lymphoma
- Medical subject headings
- Lymphoma, B-Cell, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD19-targeting CAR T Cells infusionBiological
CD19-targeting 2nd generation CAR t cells infusion for refractory B cell lymphoma
| Study group | Role | What they receive |
|---|---|---|
| CAR T cells | Experimental | In interventional studies, participants are assigned to accept CD19-targeting CAR T Cells infusion so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. Arm refers to each group or subgroup of participants in a clinical trial that receives specfic interventions (or no intervention) according to the study protocol. This is decided before the trial begins. Receives: Biological: CD19-targeting CAR T Cells infusion |
| No Intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
CAR T cell persistence
Presence of circulating CAR T cells will be evaluated with flow cytometry and real time PCR in patient blood
Measured: up to 24 months
Secondary outcomes (1)
Tumor load
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 posted14 Sep 2015 (estimated)
- Study startSep 2015
- Primary completion15 Aug 2016
- Study completion15 Aug 2016
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fuda Cancer Hospital, Guangzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lizhi Niu, PhD, Study chair, Fuda Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02547948
- Sponsor's protocol ID
- CD19-targeting CAR T
- Status last verified
- Jul 2020
- First submitted
- 4 Sep 2015
- Last updated
- 16 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CD19-targeting CAR T Cells for Refractory B Cell Lymphoma
- ClinicalTrials.gov ID
- NCT02547948
- Acronym / sponsor ID
- CD19-targeting CAR T
- Conditions
- B Cell Lymphoma
- Keywords
- CD19, CAR T Cells, Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fuda Cancer Hospital, GuangzhouUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- 15 Aug 2016 (actual)
- Study completion
- 15 Aug 2016 (actual)
- First posted
- 14 Sep 2015 (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.
The purpose of this study is to evaluate the safety and efficacy of CD19-targeting CAR T Cells infusion for B Cell Lymphoma.
Detailed description
Chimeric antigen receptor (CAR) T cells targeting CD19 will be evaluated for safety and efficacy in patients with B cell lymphoma or leukemia. The CAR consists of a CD19 targeting antibody scFv with two intracellular signaling domains derived from CD3 zeta and CD28. Autologous T cells will be gene-engineered with the CAR gene using a retrovirus 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAR T cells | Experimental | Biological: CD19-targeting CAR T Cells infusionIn interventional studies, participants are assigned to accept CD19-targeting CAR T Cells infusion so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. Arm refers to each group or subgroup of participants in a clinical trial that receives specfic interventions (or no intervention) according to the study protocol. This is decided before the trial begins. |
| No Intervention | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Relapsed or refractory CD19+ B-cell lymphoma.
- Measurable disease.
- Performance status ECOG 0-2.
- Age:18-80.
- Fertile females/males must consent to use contraceptives during participation of the trial.
Key exclusion criteria (8 listed)
- Any significant medical or psychiatric illness that would prevent the patient from giving informed consent or from following the study procedures.
- Patients with primary CNS lymphoma.
- Known human immunodeficiency virus (HIV) infection.
- Active and/or severe infection (e.g. tuberculosis, sepsis and opportunistic infections, active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection).
- Other serious underlying medical conditions, which, in the Investigator's judgment, could impair the ability of the patient.
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-targeting CAR T Cells infusionCD19-targeting 2nd generation CAR t cells infusion for refractory B cell lymphoma | Biological | CAR T cells |
Primary outcome
CAR T cell persistence
Time frame: up to 24 months
Presence of circulating CAR T cells will be evaluated with flow cytometry and real time PCR in patient blood
1 secondary outcome
Tumor load
Time frame: up to 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2020.
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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.
Lizhi Niu, PhD study chair
Fuda Cancer 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 CD19-targeting CAR T Cells infusion in people with B Cell Lymphoma, run by Fuda Cancer Hospital, Guangzhou 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 6 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: withdrawn, as of the sponsor's last update on 16 Jul 2020. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CAR T cell persistence (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 16 Jul 2020.