LymphomaPhase 1/2NCT03118180
CD19 Targeted Chimeric Antigen Receptor T Cells for B Cell Lymphoma
A Phase 1/2 study testing CD19 targeted chimeric antigen receptor T cells in people with Lymphoma, run by Zhejiang University at 1 site in China.
Trial summary
A prospective study to evaluate the safety and efficacy of CART19 for refractory/relapsed B cell lymphoma. Read more about this study
- Who is it for?
- Ages Up to 65 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- CD19 targeted chimeric antigen receptor T cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 5 Apr 2017to 31 Dec 2020
- 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 Up to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histologically confirmed aggressive B cell lymphoma
- Chemotherapy-refractory disease, defined as one or more of the following:
- No response to first-line therapy (primary refractory disease); PD as best response to first-line therapy SD as best response after at least 4 cycles of first-line therapy (e.g., 4 cycles of R- CHOP) with SD duration no longer than 6 months from last dose of therapy OR No response to second or greater lines of therapy PD as best response to most recent therapy regimen SD as best response after at least 2 cycles of last line of therapy with SD duration no longer than 6 months from last dose of therapy OR Refractory post-ASCT Disease progression or relapsed ≤12 months of ASCT (must have biopsy proven recurrence in relapsed subjects) if salvage therapy is given post-ASCT, the subject must have had no response to or relapsed after the last line of therapy
- Toxicities due to prior therapy must be stable and recovered to ≤ Grade 1 (except for clinically non-significant toxicities such as alopecia)
- Age 18 or older
- Eastern cooperative oncology group (ECOG) performance status of 0 or 1
Show all 12Show fewer
- ANC ≥1000/uL
- Platelet count ≥75,000/uL
- Absolute lymphocyte count ≥100/uL
- Adequate renal, hepatic, pulmonary and cardiac function defined as:
- Creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 mL/min Serum ALT/AST ≤2.5 ULN Total bilirubin ≤1.5 mg/dl, except in subjects with Gilbert's syndrome. Cardiac ejection fraction ≥ 50% ,no evidence of pericardial effusion as determined by an ECHO, and no clinically significant ECG findings No clinically significant pleural effusion Baseline oxygen saturation >92% on room air
- Females of childbearing potential must have a negative serum or urine pregnancy test (females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential)
Who cannot join
- History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) or follicular lymphoma unless disease free for at least 3 years
- History of Richter's transformation of CLL
- Autologous stem cell transplant within 6 weeks of planned CAR-C19 infusion
- History of allogeneic stem cell transplantation
- Prior CD19 targeted therapy with the exception of subjects who received CAR-C19 in this study and are eligible for re-treatment
- Prior chimeric antigen receptor therapy or other genetically modified T cell therapy
Show all 24Show fewer
- History of severe, immediate hypersensitivity reaction attributed to aminoglycosides
- Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management. Simple UTI and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with the K Medical Monitor.
- Known history of infection with HIV or hepatitis B (HBsAg positive) or hepatitis C virus (anti- HCV positive). A history of treated hepatitis B or hepatitis C is permitted if the viral load is undetectable per quantitative PCR and/or nucleic acid testing.
- Presence of any indwelling line or drain (e.g., percutaneous nephrostomy tube, indwelling foley catheter, biliary drain, or pleural/peritoneal/pericardial catheter). Dedicated central venous access catheters such as a Port-a-Cath or Hickman catheter are permitted
- Subjects with detectable cerebrospinal fluid malignant cells, or brain metastases, or with a history of CNS lymphoma, cerebrospinal fluid malignant cells or brain metastases
- History or presence of CNS disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement
- Subjects with cardiac atrial or cardiac ventricular lymphoma involvement
- History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment
- Requirement for urgent therapy due to tumor mass effects such as bowel obstruction or blood vessel compression
- Primary immunodeficiency
- History of deep vein thrombosis or pulmonary embolism within 6 months of enrollment
- Any medical condition likely to interfere with assessment of safety or efficacy of study treatment
- History of severe immediate hypersensitivity reaction to any of the agents used in this study
- Live vaccine ≤ 6 weeks prior to start of conditioning regimen
- Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant. Females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential
- Subjects of both genders who are not willing to practice birth control from the time of consent through 6 months after the completion of CAR-C19
- In the investigators judgment, the subject is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation
- History of autoimmune disease (e.g. Crohns, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital,School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003
Yongxian Hu, Dr, 15957162012
Jian Yu, Dr, 86 571 87236706, 37478898@qq.com
About this study
Official title: The Safety and Efficacy Evaluation of CD19 Targeted Chimeric Antigen Receptor T Cells for B Cell Lymphoma
A prospective study to evaluate the safety and efficacy of CART19 for refractory/relapsed B cell lymphoma.
Read the detailed description
A prospective study to evaluate the safety and efficacy of CART19 for refractory/relapsed B cell lymphoma. Complete remission rate, overall survival rate, relapse rate and CRS rate were monitored. CART associated toxicities were also monitored.
- Conditions
- Lymphoma
- Being tested
- CD19 targeted chimeric antigen receptor T cells
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD19 targeted chimeric antigen receptor T cellsBiological
CD19 targeted chimeric antigen receptor T cells for refractory and relapsed B cell lymphoma
| Study group | Role | What they receive |
|---|---|---|
| CART19 group | Experimental | All patients were included for CART19 therapy Receives: Biological: CD19 targeted chimeric antigen receptor T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall response rate
the number of response patients/the number of total patients
Measured: Up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start5 Apr 2017
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Innovative Cellular Therapeutics Co., Ltd.
- Responsible party
- Principal investigator, He Huang, Zhejiang University
- Investigators
- He Huang, Dr, Principal investigator, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03118180
- Sponsor's protocol ID
- CART19-001
- Status last verified
- Apr 2017
- First submitted
- 11 Apr 2017
- Last updated
- 18 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy Evaluation of CD19 Targeted Chimeric Antigen Receptor T Cells for B Cell Lymphoma
- ClinicalTrials.gov ID
- NCT03118180
- Acronym / sponsor ID
- CART19-001
- Conditions
- Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Innovative Cellular Therapeutics Co., Ltd.
- Study start
- 5 Apr 2017 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 18 Apr 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.
A prospective study to evaluate the safety and efficacy of CART19 for refractory/relapsed B cell lymphoma.
Detailed description
A prospective study to evaluate the safety and efficacy of CART19 for refractory/relapsed B cell lymphoma. Complete remission rate, overall survival rate, relapse rate and CRS rate were monitored. CART associated toxicities were also monitored.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CART19 group | Experimental | Biological: CD19 targeted chimeric antigen receptor T cellsAll patients were included for CART19 therapy |
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically confirmed aggressive B cell lymphoma
- Chemotherapy-refractory disease, defined as one or more of the following:
- No response to first-line therapy (primary refractory disease); PD as best response to first-line therapy SD as best response after at least 4 cycles of first-line therapy (e.g., 4 cycles of R- CHOP) with SD duration no longer than 6 months from last dose of therapy OR No response to second or greater lines of therapy PD as best response to most recent therapy regimen SD as best response after at least 2 cycles of last line of therapy with SD duration no longer than 6 months from last dose of therapy OR Refractory post-ASCT Disease progression or relapsed ≤12 months of ASCT (must have biopsy proven recurrence in relapsed subjects) if salvage therapy is given post-ASCT, the subject must have had no response to or relapsed after the last line of therapy
- Toxicities due to prior therapy must be stable and recovered to ≤ Grade 1 (except for clinically non-significant toxicities such as alopecia)
- Age 18 or older
Key exclusion criteria (24 listed)
- History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) or follicular lymphoma unless disease free for at least 3 years
- History of Richter's transformation of CLL
- Autologous stem cell transplant within 6 weeks of planned CAR-C19 infusion
- History of allogeneic stem cell transplantation
- Prior CD19 targeted therapy with the exception of subjects who received CAR-C19 in this study and are eligible for re-treatment
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 chimeric antigen receptor T cellsCD19 targeted chimeric antigen receptor T cells for refractory and relapsed B cell lymphoma | Biological | CART19 group |
Primary outcome
overall response rate
Time frame: Up to 30 months
the number of response patients/the number of total patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Lymphoma
RecruitingPhase 1
A Study of LY4584180 in Adult Participants With Previously Treated Blood Cancers
Lymphoma, Non-Hodgkin's, Lymphoma, Diffuse Large B-Cell
RecruitingPhase 3
A Study to Compare How Well Odronextamab Combined With Chemotherapy Works and How Safe it is Against Rituximab Combined With Chemotherapy, in Adult Patients With Previously Untreated Diffuse Large B-cell Lymphoma
Diffuse Large B-cell Lymphoma (DLBCL)
RecruitingObservational study
Natural History Study to Determine Drug Metabolism Phenotype and Appropriate Germline Source DNA in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant
Leukemia, Lymphoma
Active, not recruitingPhase 3
Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma
Primary Mediastinal Large B-Cell Lymphoma
RecruitingObservational study
cfDNA Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease
Brain Cancer, Breast Cancer
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.
He Huang, Dr principal investigator
First Affiliated Hospital of Zhejiang 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 CD19 targeted chimeric antigen receptor T cells in people with Lymphoma, run by 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 12 inclusion and 24 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 18 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 Yongxian Hu, Dr (15957162012, huyongxian2000@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall response rate (time frame: Up to 30 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 18 Apr 2017.