B Cell LymphomaPhase 2NCT03258047
Novel Autologou CAR-T Therapy for Relapsed/Refractory B Cell Lymphoma
A Phase 2 study testing CAR-T in people with B Cell Lymphoma, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
It's a single arm, open label prospective study, in which the safety and efficacy of autologous CAR-T are evaluated in refractory/relapsed B cell lymphoma patients. Abbreviation: CAR-T: Chimeric Antigen Receptor T-Cell Immunotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B Cell Lymphoma
- What is being tested?
- CAR-T
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2017to 30 Jul 2019
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age≥18 years, male or female;
- Karnofsky≥60%；
- B cell lymphoma patients who are not available for the following treatment: autologous stem cell transplantation, allogeneic stem cell transplantation, or patients with short expected survival (less than 2 years).
- Patients with CR2 or CR3 and no stem cell transplantation available due to age, disease condition, lack of donors or any other reasons.
- Patients have had more than 2 combined chemotherapy regimens;
- Creatinin <2.5mg/dL；ALT/AST level <3 times of the maximum of normal range; bilirubin<3mg/dL；
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- Proper venous condition for leukapheresis, no contraindication for leukapheresis;
- Patient that could understand and is willing to sign the written consent;
- Fertile female patient should be willing to take contraceptive measures.
- Patient that is willing to follow up till at least 2 months after T cell re-transfusion.
Who cannot join
- Patients who need ≥15mg prednisone daily due to any cause;
- Patients with autoimmune disease and need immunosuppressor treatment;
- Serum creatinin>2.5 mg/dL；serum AST >5 times of normal maximum; bilirubin >3 mg/Dl;
- FEV1<2 L，diffusion capacity for carbon monoxide of lung (DLCO) <40%；
- Cardiovascular abnormalities that fulfill any of the following: NYHA level III or IV congestive heart failure, severe clinical hypotention; uncontrollable carotid heart disease; or ejection fraction<35%；
- Patients with HIV infection, active Hepatitis B or Hepatitis C infection;
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- Patients that have previously received gene therapy of any kind;
- Obvious clinical encephalopathy or novel neuron function damage;
- Patients with active infection;
- Patients had biological treatment, immunotherapy or radiation therapy within 1 month prior to enrollment or are currently under these treatment;
- Patients who had allergic history to agents of the similar structure as CAR-T;
Trial locations and contacts
1 site in 1 country.
China1 site
The first affiliated hospital of Zhejiang University
Hangzhou, Zhejiang, 310000
About this study
It's a single arm, open label prospective study, in which the safety and efficacy of autologous CAR-T are evaluated in refractory/relapsed B cell lymphoma patients.
Abbreviation: CAR-T: Chimeric Antigen Receptor T-Cell Immunotherapy.
- Conditions
- B Cell Lymphoma
- Being tested
- CAR-T
- 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.
CAR-TCombination product
CAR-T is a novel technique for cancer treatent, it includes procedures of modifying patients' T cells outside the body and re-transfuse these cells back into the human body to fight against the cancer cells.
| Study group | Role | What they receive |
|---|---|---|
| CAR-T treatment | Experimental | In this group, patients will be treated with autologous CAR-T, and the safety and efficacy will be evaluated Receives: Combination Product: CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete remission rate
complete remission rate after treated by CAR-T therapy
Measured: every 3 months until 20 months after the last patient's enrollment
Secondary outcomes (4)
progression free survival
from date of inclusion to date of progression, relapse, or death from any cause
Measured: from the day of treatment to the date of first documented progression，up to 20 months after the last patient's enrollment
overall survival
from the date of inclusion to date of death, irrespective of cause
Measured: 20 months after the last patient's enrollment
adverse events
any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure
Measured: from the date of the start of treatment to 20 months after last patient's enrollment
duration of the modified T cells by CAR-T in the patients
time from re-transfusion to date when the modified T cells become non-detectable.
Measured: from the date of re-transfusison to 20 months after last patient's enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study start15 Sep 2017
- Primary completion13 Jan 2019
- Study completion30 Jul 2019 (estimated)
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.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenbin Qian, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03258047
- Sponsor's protocol ID
- lymphoma center Q002
- Status last verified
- Feb 2019
- First submitted
- 20 Aug 2017
- Last updated
- 15 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All the data would be available on the corresponding website of the leading research center.
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Autologou CAR-T Therapy for Relapsed/Refractory B Cell Lymphoma
- ClinicalTrials.gov ID
- NCT03258047
- Acronym / sponsor ID
- lymphoma center Q002
- Conditions
- B Cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 13 Jan 2019 (actual)
- Study completion
- 30 Jul 2019 (estimated)
- First posted
- 22 Aug 2017 (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.
It's a single arm, open label prospective study, in which the safety and efficacy of autologous CAR-T are evaluated in refractory/relapsed B cell lymphoma patients.
Abbreviation: CAR-T: Chimeric Antigen Receptor T-Cell Immunotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAR-T treatment | Experimental | Combination Product: CAR-TIn this group, patients will be treated with autologous CAR-T, and the safety and efficacy will be evaluated |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age≥18 years, male or female;
- Karnofsky≥60%；
- B cell lymphoma patients who are not available for the following treatment: autologous stem cell transplantation, allogeneic stem cell transplantation, or patients with short expected survival (less than 2 years).
- Patients with CR2 or CR3 and no stem cell transplantation available due to age, disease condition, lack of donors or any other reasons.
- Patients have had more than 2 combined chemotherapy regimens;
Key exclusion criteria (11 listed)
- Patients who need ≥15mg prednisone daily due to any cause;
- Patients with autoimmune disease and need immunosuppressor treatment;
- Serum creatinin>2.5 mg/dL；serum AST >5 times of normal maximum; bilirubin >3 mg/Dl;
- FEV1<2 L，diffusion capacity for carbon monoxide of lung (DLCO) <40%；
- Cardiovascular abnormalities that fulfill any of the following: NYHA level III or IV congestive heart failure, severe clinical hypotention; uncontrollable carotid heart disease; or ejection fraction<35%；
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 |
|---|---|---|
| CAR-TCAR-T is a novel technique for cancer treatent, it includes procedures of modifying patients' T cells outside the body and re-transfuse these cells back into the human body to fight against the cancer cells. | Combination product | CAR-T treatment |
Primary outcome
complete remission rate
Time frame: every 3 months until 20 months after the last patient's enrollment
complete remission rate after treated by CAR-T therapy
4 secondary outcomes
progression free survival
Time frame: from the day of treatment to the date of first documented progression，up to 20 months after the last patient's enrollment
overall survival
Time frame: 20 months after the last patient's enrollment
adverse events
Time frame: from the date of the start of treatment to 20 months after last patient's enrollment
duration of the modified T cells by CAR-T in the patients
Time frame: from the date of re-transfusison to 20 months after last patient's enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Individual participant dataSharing planned: Yes. All the data would be available on the corresponding website of the leading research center.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CAR-T in people with B Cell Lymphoma, run by First Affiliated Hospital of Zhejiang University 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 10 inclusion and 11 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 15 Feb 2019. 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 phase mean?
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?
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?
complete remission rate (time frame: every 3 months until 20 months after the last patient's enrollment). 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 15 Feb 2019.