Lymphoma, B-CellPhase 1/2NCT02965157
Pilot Study of Anti-CD20-CAR-engineered T Cells in Patients With Chemotherapy Resistant or Refractory CD20+ Lymphoma
A Phase 1/2 study testing CART20 in people with Lymphoma, B-Cell, run by Beijing Biohealthcare Biotechnology Co.,Ltd at 1 site in China.
Trial summary
Chimeric antigen receptor (CAR) T cells targeting CD20 will be evaluated for safety and efficacy in patients with CD20+ B cell lymphoma. The CAR consists of a CD20 targeting antibody scFv with two intracellular signaling domains derived from CD3 zeta and CD28. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lymphoma, B-Cell
- What is being tested?
- CART20
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- Aug 2016to Jan 2018
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Relapsed or refractory CD20+ B-cell lymphoma.
- Measurable disease.
- Performance status ECOG 0-2.
- Age:18-65.
- 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.
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- 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, 1 recruiting
- Recruiting
Chinese Academy of Medical Sciences Tumor Hospital
Beijing
Shuting professor Li, doctor, 8610-87788495, csmocaco@126.com
Yuankai professor Shi, doctor
About this study
Chimeric antigen receptor (CAR) T cells targeting CD20 will be evaluated for safety and efficacy in patients with CD20+ B cell lymphoma. The CAR consists of a CD20 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
- Lymphoma, B-Cell
- Being tested
- CART20
- 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.
CART20Biological
| Study group | Role | What they receive |
|---|---|---|
| CART20 | Experimental | Not described Receives: Biological: CART20 |
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause mortality
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2016 (estimated)
- Study startAug 2016
- Primary completionJan 2018 (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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Biohealthcare Biotechnology Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02965157
- Sponsor's protocol ID
- EY201605-19
- Status last verified
- Aug 2016
- First submitted
- 31 Aug 2016
- Last updated
- 16 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Anti-CD20-CAR-engineered T Cells in Patients With Chemotherapy Resistant or Refractory CD20+ Lymphoma
- ClinicalTrials.gov ID
- NCT02965157
- Acronym / sponsor ID
- EY201605-19
- Conditions
- Lymphoma, B-Cell
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Beijing Biohealthcare Biotechnology Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- Aug 2016
- Primary completion
- Jan 2018 (estimated)
- First posted
- 16 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 CD20 will be evaluated for safety and efficacy in patients with CD20+ B cell lymphoma. The CAR consists of a CD20 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CART20 | Experimental | Biological: CART20 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Relapsed or refractory CD20+ B-cell lymphoma.
- Measurable disease.
- Performance status ECOG 0-2.
- Age:18-65.
- Fertile females/males must consent to use contraceptives during participation of the trial.
Key exclusion criteria (9 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 |
|---|---|---|
| CART20 | Biological | CART20 |
Primary outcome
all cause mortality
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2016.
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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.
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 CART20 in people with Lymphoma, B-Cell, run by Beijing Biohealthcare Biotechnology 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 6 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 16 Nov 2016. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all cause mortality (time frame: one year). 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 Nov 2016.