Leukemia, B-CellNCT02813837
Chimeric Antigen Receptor T Cells (CART) Therapy in Refractory/Relapsed B Cell Hematologic Malignancies
A study testing CD19CART in people with Leukemia, B-Cell and Lymphoma, B-Cell, run by Innovative Cellular Therapeutics Co., Ltd. at 1 site in China.
Trial summary
This single arm, open-label, multi-center clinical trial is studying CD19 targeted chimeric antigen receptor T cells therapy in treating patients with CD19 positive malignant B-cell derived leukemia and lymphoma that is relapsed (after stem cell transplantation or chemotherapy) or refractory to chemotherapy. Read more about this study
- Who is it for?
- Ages Up to 60 years
- Conditions the study is for
- Leukemia, B-Cell, Lymphoma, B-Cell
- What is being tested?
- CD19CART
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Jun 2015to Jul 2021
- Phase
- Interventional
- 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 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients diagnosed as CD19 positive refractory and relapsed B cell hematologic malignancies included acute lymphoblastic leukemia (ALL),chronic lymphocytic leukemia(CLL),non-Hodgkin's lymphoma(NHL)
- not eligible or appropriate for auto-HSCT or allo-HSCT or relapsed after hematopoietic stem cell transplant(HSCT)
- At least one measurable lesion defined as one lesion larger than 1.5cm or two lesion more than 1.0cm(for patients with NHL )
- Age ≤60 years
- Eastern Cooperative Oncology Group(ECOG) Performance status 0 to 2, Expected survival > 6 months
- Left Ventricular Ejection Fraction (LVEF) > 50%
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- no history of other malignancies;
- no other serious diseases which conflict with the treatment in the present trial
- All patients should consent to adopt efficient contraception methods during the treatment and after the treatment. The pregnant tests of women who are in child bearing period should be negative before the treatment.
- patients should understand and are willing to participate in the trial. Inform consent form is supposed to obtained before treatment
Who cannot join
- Diagnosis or classification undefined
- Those with primary central nervous system lymphoma or testicular leukaemia or lymphoma
- Patients with a known history or prior diagnosis of epilepsia or other disease affecting the central nervous system, or serious mental diseases;
- Patients who have secondary leukaemia or lymphoma after chemotherapy or radiotherapy for other malignancies
- Active acute or chronic graft-versus-host disease (GVHD) requiring systemic therapy, concurrent use of immunosuppressant medications
- Class III/IV cardiovascular disability according to the New York Heart Association Classification
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- Pregnant or lactating women(the safety of this therapy on unborn children is not known)
- With active infection
- Active hepatitis B, hepatitis C or syphilis infection
- Patients use of systemic steroids within 2 weeks. Recent or current use of inhaled steroids is not exclusionary
- Prior treatment with gene therapy product
- Cluster of differentiation 3(CD3) positive cells<0.9x10^4/ml in peripheral blood (PB)
- Organ function meeting following criteria: liver and renal function: alanine aminotransferase(ALT)/aspartate aminotransferase(AST) > 3 times the upper limit of normal, or bilirubin>2.0 mg/dl（34.2umol/L）, or creatinine >2.5mg/dl（221.0umol/L） ; hematopoietic function:Neutrophil count<1.0x10^9/L，hemoglobin<80g/L，platelet <50x10^9/L(for patients with NHL )
- Any uncontrolled active medical disorder that would preclude participation as outlined
- HIV infection
- The researchers considered unsuitable to participate in this clinical study.
- Patients with poor compliance
Trial locations and contacts
1 site in 1 country.
Lei Xiao, Ph.D contact
China1 site, 1 recruiting
- Recruiting
Innovative Cellular Therapeutics CO., LTD.
Shanghai
Lei Xiao, Ph.D, +86-21-58950719
Yu Hu, Ph.D
About this study
Official title: A Multicenter Efficacy and Safety Study of Cluster of Differentiation 19 (CD19)-Targeted CART (CD19CART) Therapy for CD19 Positive Relapsed or Refractory B-cell Hematologic Malignancies (SCT019-01）
This single arm, open-label, multi-center clinical trial is studying CD19 targeted chimeric antigen receptor T cells therapy in treating patients with CD19 positive malignant B-cell derived leukemia and lymphoma that is relapsed (after stem cell transplantation or chemotherapy) or refractory to chemotherapy.
Read the detailed description
This single arm, open-label, multi-center clinical trial is studying CD19 targeted chimeric antigen receptor T cells therapy in treating patients with CD19 positive malignant B-cell derived leukemia and lymphoma that is relapsed (after stem cell transplantation or chemotherapy) or refractory to chemotherapy. When patients enroll in this trial, autologous CD19CART cells were generated from the mononuclear cells of the patient's peripheral blood (PB). During the term of cell preparation of CD19CART cells, patients will receive a conditioning regimen. One day after completing conditioning regimen, the patient will be given infusions of CD19CART cells into the vein over a period of 1 to 3 days. Patients will be monitored for a response, toxic effects, and the expansion and persistence of circulating CD19CART cells.
- Conditions
- Leukemia, B-Cell, Lymphoma, B-Cell
- Being tested
- CD19CART
- Keywords
- relapsed, refractory, CD19+, leukemia, lymphoma
- Medical subject headings
- Leukemia, B-Cell, Lymphoma, B-Cell, Recurrence, Leukemia, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD19CARTBiological
Also called CD19-directed chimeric antigen receptor modified T cells
Patients will be given infusions of CD19CART cells into the vein over a period of 1 to 3 days. The target dose range administered in this study is 1x10e5-1x10e7 CD19CART cells/kg. Patients will be monitored for a response, toxic effects, and the expansion and persistence of circulating CD19CART cells.
| Study group | Role | What they receive |
|---|---|---|
| single arm | Experimental | Experimental: CD19 CART cell.The target dose range administered in this study is 1x10e5-1x10e7 CART-19 cells/kg. Receives: Biological: CD19CART |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of study related adverse events
Measured: up to 12 months
Secondary outcomes (1)
Anti-leukemia or lymphoma responses to CD19CART cell infusions
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2016 (estimated)
- Study startJun 2015
- Primary completionJan 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innovative Cellular Therapeutics Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu Hu, Ph.D, Study director, Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyHe Huang, Ph.D, Study director, The First Affiliated Hospital of the College of Medicine, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02813837
- Sponsor's protocol ID
- SCT019-01
- Status last verified
- Jun 2016
- First submitted
- 19 Jun 2016
- Last updated
- 28 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Efficacy and Safety Study of Cluster of Differentiation 19 (CD19)-Targeted CART (CD19CART) Therapy for CD19 Positive Relapsed or Refractory B-cell Hematologic Malignancies (SCT019-01）
- ClinicalTrials.gov ID
- NCT02813837
- Acronym / sponsor ID
- SCT019-01
- Conditions
- Leukemia, B-Cell, Lymphoma, B-Cell
- Keywords
- relapsed, refractory, CD19+, leukemia, lymphoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Innovative Cellular Therapeutics Co., Ltd.University, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 27 Jun 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.
This single arm, open-label, multi-center clinical trial is studying CD19 targeted chimeric antigen receptor T cells therapy in treating patients with CD19 positive malignant B-cell derived leukemia and lymphoma that is relapsed (after stem cell transplantation or chemotherapy) or refractory to chemotherapy.
Detailed description
This single arm, open-label, multi-center clinical trial is studying CD19 targeted chimeric antigen receptor T cells therapy in treating patients with CD19 positive malignant B-cell derived leukemia and lymphoma that is relapsed (after stem cell transplantation or chemotherapy) or refractory to chemotherapy. When patients enroll in this trial, autologous CD19CART cells were generated from the mononuclear cells of the patient's peripheral blood (PB). During the term of cell preparation of CD19CART cells, patients will receive a conditioning regimen. One day after completing conditioning regimen, the patient will be given infusions of CD19CART cells into the vein over a period of 1 to 3 days. Patients will be monitored for a response, toxic effects, and the expansion and persistence of circulating CD19CART cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | Experimental | Biological: CD19CARTExperimental: CD19 CART cell.The target dose range administered in this study is 1x10e5-1x10e7 CART-19 cells/kg. |
Who may qualify
- Ages
- Up to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Patients diagnosed as CD19 positive refractory and relapsed B cell hematologic malignancies included acute lymphoblastic leukemia (ALL),chronic lymphocytic leukemia(CLL),non-Hodgkin's lymphoma(NHL)
- not eligible or appropriate for auto-HSCT or allo-HSCT or relapsed after hematopoietic stem cell transplant(HSCT)
- At least one measurable lesion defined as one lesion larger than 1.5cm or two lesion more than 1.0cm(for patients with NHL )
- Age ≤60 years
- Eastern Cooperative Oncology Group(ECOG) Performance status 0 to 2, Expected survival > 6 months
Key exclusion criteria (17 listed)
- Diagnosis or classification undefined
- Those with primary central nervous system lymphoma or testicular leukaemia or lymphoma
- Patients with a known history or prior diagnosis of epilepsia or other disease affecting the central nervous system, or serious mental diseases;
- Patients who have secondary leukaemia or lymphoma after chemotherapy or radiotherapy for other malignancies
- Active acute or chronic graft-versus-host disease (GVHD) requiring systemic therapy, concurrent use of immunosuppressant medications
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 |
|---|---|---|
| CD19CARTAlso: CD19-directed chimeric antigen receptor modified T cellsPatients will be given infusions of CD19CART cells into the vein over a period of 1 to 3 days. The target dose range administered in this study is 1x10e5-1x10e7 CD19CART cells/kg. Patients will be monitored for a response, toxic effects, and the expansion and persistence of circulating CD19CART cells. | Biological | single arm |
Primary outcome
Occurrence of study related adverse events
Time frame: up to 12 months
1 secondary outcome
Anti-leukemia or lymphoma responses to CD19CART cell infusions
Time frame: up to 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2016.
- Individual participant dataSharing planned: Undecided
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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.
Lei Xiao, Ph.D contact
Yu Hu, Ph.D study director
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
He Huang, Ph.D study director
The First Affiliated Hospital of the College of Medicine, Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CD19CART in people with Leukemia, B-Cell and Lymphoma, B-Cell, run by Innovative Cellular Therapeutics 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 10 inclusion and 17 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 Jun 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.
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 Lei Xiao, Ph.D (+86-21-58950719), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of study related adverse events (time frame: up to 12 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 Jun 2016.