Acute Lymphocytic LeukemiaPhase 1/2NCT03191773
A Study of Anti-CD19 CAR-T Cell Immunotherapy for Refractory /Relapsed B Cell Malignancies
A Phase 1/2 study testing Drugs and anti-CD19 CAR transduced T cells in people with Acute Lymphocytic Leukemia and Chronic Lymphocytic Leukemia, run by Second Affiliated Hospital of Guangzhou Medical University at 5 sites in China.
Trial summary
Autologous T cells engineered to express an anti-CD19 chimeric antigen receptor (CAR) will be infused back to patients with refractory /relapsed B cell malignancies, including lymphoma and leukemia. Read more about this study
- Who is it for?
- Ages 14 to 80 years
- Conditions the study is for
- Acute Lymphocytic Leukemia, Chronic Lymphocytic Leukemia, Lymphoma
- What is being tested?
- Drugs and anti-CD19 CAR transduced T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 5 sitesChina
- Study dates
- 30 Jun 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 14 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must have a CD19+ B cell malignancy，including relapsed or refractory B cell leukemia and/or B cell lymphoma；
- Patients must have a measurable or evaluable disease at the time of enrollment, which may include any evidence of disease including minimal residual disease detected by flow cytometry, cytogenetics, or polymerase chain reaction (PCR) analysis；
- Patients with history of allogeneic stem cell transplantation are eligible, providing 6 months had elapsed from SCT, they have no evidence of active graft-versus-host disease (GVHD) and no longer taking immunosuppressive agents during the treatment;
- Able to understand and sign the Informed Consent Document；
- There is no obvious dysfunctions in heart , liver, lung, kidney, and performance status with ECOG < 2；
- Life expectancy：More than 3 months for leukemia and more than 6 months for lymphoma.
Who cannot join
- Patients that require urgent therapy due to tumor mass effects such as bowel obstruction or blood vessel compression；
- Patients that have active hemolytic anemia；
- Patients who have uncontrollable infectious diseases within 2 weeks before enrollment;
- Patients with human immunodeficiency virus (HIV) antibody seropositive;
- Active infection of Hepatitis B virus and / or hepatitis C virus;
- Patients with any residual intracranial implants；
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- Coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system；
- Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease)；
- Concurrent opportunistic infections；
- Concurrent systemic steroid therapy；
- History of severe immediate hypersensitivity reaction to any of the agents used in this study；
- Women of child-bearing potential who are pregnant or breastfeeding；
- Patients with cardiac atrial or cardiac ventricular lymphoma involvement；
- Other anti-neoplastic investigational agents currently or within 30 days prior to start of the treatment；
- Psychiatric patients;
- Previous treatment with any gene therapy products.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Department of Hematology, Dongguan People's Hospital
Dongguan, Guangdong
Yirong Jiang, MD, 0086 13688967985, dgjyr0769@163.com
Yirong Jiang, MD
- Recruiting
Department of Hematology, the First People's Hospital of Foshan
Foshan, Guangdong
Zhuowen Chen, MD, 0086 18928617712, czwen@fsyyy.com
Wei Luo, MD, 0086 18038865996, luowei_421@163.com
- Recruiting
Department of Hematology, Guangzhou First People's Hospital
Guangzhou, Guangdong
Shunqing Wang, 0086 13437801998, drwangshq@medmail.com.cn
Shunqing Wang, MD
- Recruiting
Department of Hematology, The First Affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou, Guangdong
Xueyi Pan, 0086 13922217835, xypan88@163.com
Xueyi Pan, MD
- Recruiting
Department of Hematology,the Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
Ying Feng, MD, 0086 13602723030, fyzlply@163.com
Ying Feng, MD
About this study
Official title: A Prospective, Multicenter, Single-Arm Study of Anti-CD19 CAR-T Cell Immunotherapy for Refractory /Relapsed B Cell Malignancies
Autologous T cells engineered to express an anti-CD19 chimeric antigen receptor (CAR) will be infused back to patients with refractory /relapsed B cell malignancies, including lymphoma and leukemia. The patients will be monitored after infusion of anti-CD19 CAR-transduced T cells for safety,adverse events, persistence of anti-CD19 CAR-transduced T cells and treatment efficacy.
Read the detailed description
Despite progress has been made to date in the treatment of patients with B cell malignancies, including leukemia and lymphoma, many patients with relapsed or refractory diseases do not respond to the standard treatments. It has been shown that anti-CD19 CAR-transduced T cells may be an effective approach to treat the relapsed or refractory diseases. The procedure involves collecting PBMCs from the patients and modifying the T cells to attack the malignant B cells. In this trial, autologous T cells engineered to express an anti-CD19 chimeric antigen receptor (CAR) containing the signaling domains of CD28 or 4-1BB and CD3-zeta will be infused back to patients with B cell malignancies, including lymphoma and leukemia. The patients will be pretreated with a lymphodepleting preconditioning regimen before the infusion of anti-CD19 CAR T cells, and will be monitored for safety, adverse events, persistence of anti-CD19 CAR-transduced T cells and the treatment efficacy.
- Being tested
- Drugs and anti-CD19 CAR transduced T cells
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drugs and anti-CD19 CAR transduced T cellsCombination product
Drug: Fludarabine On days -4 through -2, Fludarabine 30mg/m2 (IV) will be infused over 30 minutes.
Drug: Cyclophosphamide On days -4 through -2, Cyclophosphamide 300-500mg/m2 IV will be infused over 60 minutes followed by fludarabine.
Biological: Anti-CD19-CAR T cells On day 0, cells will be infused intravenously IV over 20 - 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Anti-CD19 CAR transduced T cells | Experimental | Patients will receive a lymphodepleting preconditioning regimen with Fludarabine and Cyclophosphamide followed by anti-CD19 CAR-transduced T cells. Receives: Combination Product: Drugs and anti-CD19 CAR transduced T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse Events
To evaluate the safety and feasibility of the administration of anti-CD19 CAR transduced T cells in patients with refractory /relapsed CD19+ B cell malignancies.
Measured: 24 months
Number of participants with clinical responses
To determine if the treatment regimen can result in clinical regression of B cell malignancies in the patients as described above.
Measured: 24 months
Secondary outcomes (1)
Evaluation of overall survial
To evaluate overall survial(OS) after administration of anti-CD19 CAR transduced T cells in patients with refractory /relapsed CD19+ B cell malignancies.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study start30 Jun 2017 (estimated)
- Primary completion31 Dec 2020 (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 Acute Lymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Guangzhou Medical 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
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen Institute for Innovation and Translational Medicine, Guangzhou First People's Hospital, First People's Hospital of Foshan, Dongguan People's Hospital, The First Affiliated Hospital of Guangdong Pharmaceutical University
- Responsible party
- Sponsor
- Investigators
- Ying Feng, MD, Study director, Second Affiliated Hospital of Guangzhou Medical UniversityMingjun Wang, MD, Study director, Shenzhen Institute for Innovation and Translational Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03191773
- Sponsor's protocol ID
- 2017-HS-32
- Status last verified
- Jun 2017
- First submitted
- 15 Jun 2017
- Last updated
- 20 Jun 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Single-Arm Study of Anti-CD19 CAR-T Cell Immunotherapy for Refractory /Relapsed B Cell Malignancies
- ClinicalTrials.gov ID
- NCT03191773
- Acronym / sponsor ID
- 2017-HS-32
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Collaborators
- Shenzhen Institute for Innovation and Translational Medicine, Guangzhou First People's Hospital, First People's Hospital of Foshan, Dongguan People's Hospital, The First Affiliated Hospital of Guangdong Pharmaceutical University
- Study start
- 30 Jun 2017 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 19 Jun 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.
Autologous T cells engineered to express an anti-CD19 chimeric antigen receptor (CAR) will be infused back to patients with refractory /relapsed B cell malignancies, including lymphoma and leukemia. The patients will be monitored after infusion of anti-CD19 CAR-transduced T cells for safety,adverse events, persistence of anti-CD19 CAR-transduced T cells and treatment efficacy.
Detailed description
Despite progress has been made to date in the treatment of patients with B cell malignancies, including leukemia and lymphoma, many patients with relapsed or refractory diseases do not respond to the standard treatments. It has been shown that anti-CD19 CAR-transduced T cells may be an effective approach to treat the relapsed or refractory diseases. The procedure involves collecting PBMCs from the patients and modifying the T cells to attack the malignant B cells. In this trial, autologous T cells engineered to express an anti-CD19 chimeric antigen receptor (CAR) containing the signaling domains of CD28 or 4-1BB and CD3-zeta will be infused back to patients with B cell malignancies, including lymphoma and leukemia. The patients will be pretreated with a lymphodepleting preconditioning regimen before the infusion of anti-CD19 CAR T cells, and will be monitored for safety, adverse events, persistence of anti-CD19 CAR-transduced T cells and the treatment efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anti-CD19 CAR transduced T cells | Experimental | Combination Product: Drugs and anti-CD19 CAR transduced T cellsPatients will receive a lymphodepleting preconditioning regimen with Fludarabine and Cyclophosphamide followed by anti-CD19 CAR-transduced T cells. |
Who may qualify
- Ages
- 14 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients must have a CD19+ B cell malignancy，including relapsed or refractory B cell leukemia and/or B cell lymphoma；
- Patients must have a measurable or evaluable disease at the time of enrollment, which may include any evidence of disease including minimal residual disease detected by flow cytometry, cytogenetics, or polymerase chain reaction (PCR) analysis；
- Patients with history of allogeneic stem cell transplantation are eligible, providing 6 months had elapsed from SCT, they have no evidence of active graft-versus-host disease (GVHD) and no longer taking immunosuppressive agents during the treatment;
- Able to understand and sign the Informed Consent Document；
- There is no obvious dysfunctions in heart , liver, lung, kidney, and performance status with ECOG < 2；
Key exclusion criteria (16 listed)
- Patients that require urgent therapy due to tumor mass effects such as bowel obstruction or blood vessel compression；
- Patients that have active hemolytic anemia；
- Patients who have uncontrollable infectious diseases within 2 weeks before enrollment;
- Patients with human immunodeficiency virus (HIV) antibody seropositive;
- Active infection of Hepatitis B virus and / or hepatitis C virus;
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 |
|---|---|---|
| Drugs and anti-CD19 CAR transduced T cellsDrug: Fludarabine On days -4 through -2, Fludarabine 30mg/m2 (IV) will be infused over 30 minutes. Drug: Cyclophosphamide On days -4 through -2, Cyclophosphamide 300-500mg/m2 IV will be infused over 60 minutes followed by fludarabine. Biological: Anti-CD19-CAR T cells On day 0, cells will be infused intravenously IV over 20 - 30 minutes. | Combination product | Anti-CD19 CAR transduced T cells |
Primary outcome
Number of participants with Adverse Events
Time frame: 24 months
To evaluate the safety and feasibility of the administration of anti-CD19 CAR transduced T cells in patients with refractory /relapsed CD19+ B cell malignancies.
Number of participants with clinical responses
Time frame: 24 months
To determine if the treatment regimen can result in clinical regression of B cell malignancies in the patients as described above.
1 secondary outcome
Evaluation of overall survial
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2017.
- Individual participant dataSharing planned: No
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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.
Ying Feng, MD study director
Second Affiliated Hospital of Guangzhou Medical University
Mingjun Wang, MD study director
Shenzhen Institute for Innovation and Translational Medicine
5 sites 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 Drugs and anti-CD19 CAR transduced T cells in people with Acute Lymphocytic Leukemia and Chronic Lymphocytic Leukemia, run by Second Affiliated Hospital of Guangzhou Medical University at 5 sites 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 16 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 20 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 Ying Feng, MD (0086 13602723030, fyzlply@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Adverse Events (time frame: 24 months). The study lists 2 primary outcomes in all. 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 20 Jun 2017.