Leukemia, Lymphocytic, Acute, B-CellPhase 1NCT03685786
CART19 Cells Treatment of MRD of B Cell Malignancies and Then Auto-HSCT
A Phase 1 study testing CART19 cell and auto-HSCT in people with Leukemia, Lymphocytic, Acute, B-Cell and Leukemia, Lymphocytic, Chronic, B-Cell, run by Shenzhen Second People's Hospital at 1 site in China.
Trial summary
The clinical study of CART19 Cells treatment for MRD of B Cell Malignancies and then auto-HSCT Read more about this study
- Who is it for?
- Ages 14 to 75 years
- Conditions the study is for
- Leukemia, Lymphocytic, Acute, B-Cell, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, B-Cell
- What is being tested?
- CART19 cell and auto-HSCT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2018to 2 Sep 2021
- Phase
- Phase 1
- 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 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1. Patients with CD19+, B cell Acute Lymphocytic Leukemia(B-ALL), B cell Chronic Lymphocytic Leukemia(B-CLL), B cell Lymphoma，who have 0.01%≤MRD<10% during upfront treatment 2. Patients must be within 12 months of initial B-ALL, B-CLL, B cell Lymphoma diagnosis 3. 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 4. Age 14 years to 75 years 5. Adequate organ function defined as:
- AST and ALT ≤ 3 times upper limit of normal range for age,
- Serum creatinine ≤ 1.6 mg/dl,
- Direct bilirubin ≤2.0 mg/dl,
- Adequate pulmonary function defined as ≤ grade 2 dyspnea and ≤ grade 2 hypoxia,
- Cardiac Left Ventricle Ejection Fraction (LVEF) ≥ 40% confirmed by ECHO/MUGA. 6. Patients with CNS disease will be eligible if CNS disease is responsive to therapy 7. Expression of CD19 on leukemic blasts demonstrated by flow cytometry or immunohistochemistry of bone marrow or peripheral blood 8. Adequate performance status defined as ECOG Performance Status 0 or 1 9. Provides written informed consent 10. Subjects of reproductive potential must agree to use acceptable birth control methods, as described in protocol
Who cannot join
- Active, uncontrolled infection
- Active hepatitis B or hepatitis C
- HIV Infection
- Class III/IV cardiovascular disability according to the New York Heart Association Classification
- Subjects with clinically apparent arrhythmia or arrhythmias who are not stable on medical management within two weeks of enrollment
- Pregnant or nursing (lactating) women Patients with a known history or prior diagnosis of optic neuritis or other
- immunologic or inflammatory disease affecting the central nervous system, and unrelated to leukemia or previous leukemia treatment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Weihong Chen
Shenzhen, Guangdong, 518035
Weihong Chen, M.D.,Ph.D., 0086-755-83366388 ext. 8199, whitney-cindy@hotmail.com
Xin Du, M.D.,Ph.D., 0086-755-83366388 ext. 8197, duxingz@medmail.com.cn
About this study
Official title: The Study of Autologous T Cells Expressing CD19 Chimeric Antigen Receptors Treatment of Minimal Residual Disease(MRD) of B Cell Malignancies and Then Autologous Hematopoietic Stem Cell Transplantation(Auto-HSCT)
The clinical study of CART19 Cells treatment for MRD of B Cell Malignancies and then auto-HSCT
Read the detailed description
The clinical study of the chimeric antigen receptor T cells (CART Cells) treatment for minimal residual disease(MRD) of B Cell Malignancies and then autologous hematopoietic stem cell transplantation(auto-HSCT).
- Conditions
- Leukemia, Lymphocytic, Acute, B-Cell, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, B-Cell
- Being tested
- CART19 cell and auto-HSCT
- Medical subject headings
- Leukemia, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CART19 cell and auto-HSCTBiological
Phase 1 Clinical Study of CD19-directed Chimeric Antigen Receptor-modified T (CART19) Cells treatment for Adult Patient with Minimal Residual Disease(MRD) of B Cell Malignancies and then Autologous Hematopoietic Stem Cell Transplantation(Auto-HSCT). Subjects will receive 0.5-4 x 10^8 transduced CAR T cells as a split dose over three days as follows:Day 0, 10% fraction: 0.5-4x10^7 CART19 cells, Day 1, 30% fraction: 1.5x10^7-1.2x10^8 CART19 cells, Day 2, 60% fraction: 3x10^7-2.4x10^8 CART19 cells. Auto-HSCT will be made about 6 mouths after CART19 cell is infused back to the patient.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: CART19 cell and auto-HSCT | Experimental | CART19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCRz:41BB administered by IV infusion. Auto-HSCT will be made about 6 mouths after CART19 cell is infused back to the patient. Receives: Biological: CART19 cell and auto-HSCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
CART19 Cells Treatment of MRD of B Cell Malignancies and Then Auto-HSCT
The incidence of conversion of minimal residual disease (MRD) to <0.01% after CART19 therapy in patients with MRD of B Cell Malignancies during upfront treatment
Measured: day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start1 Jun 2018
- Primary completion2 Jun 2021 (estimated)
- Study completion2 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Leukemia, Lymphocytic, Acute, 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Phase 1 Clinical Study of CD19-directed Chimeric Antigen Receptor-modified T Cells (CART19) treatment for the Patients with Minimal Residual Disease (MRD) of B Cell Malignancies and then Autologous Hematopoietic Stem Cell Transplantation(Auto-HSCT).
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Second People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Weihong Chen, M.D., Ph.D., Principal investigator, The second people's hospital of Shenzhen, The first affiliated hospital of Shenzhen UniversityXin Du, M.D., Ph.D., Principal investigator, The second people's hospital of Shenzhen, The first affiliated hospital of Shenzhen UniversityXiaochun Wan, Ph.D., Principal investigator, Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03685786
- Sponsor's protocol ID
- Weihong Chen06062018
- Status last verified
- Dec 2018
- First submitted
- 24 Sep 2018
- Last updated
- 7 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhou W, Chen W, Wan X, Luo C, Du X, Li X, Chen Q, Gao R, Zhang X, Xie M, Wang M. Benefits of Chimeric Antigen Receptor T-Cell Therapy for B-Cell Lymphoma. Front Genet. 2022 Jan 20;12:815679. doi: 10.3389/fgene.2021.815679. eCollection 2021.
PubMed 35126471
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Autologous T Cells Expressing CD19 Chimeric Antigen Receptors Treatment of Minimal Residual Disease(MRD) of B Cell Malignancies and Then Autologous Hematopoietic Stem Cell Transplantation(Auto-HSCT)
- ClinicalTrials.gov ID
- NCT03685786
- Acronym / sponsor ID
- Weihong Chen06062018
- Conditions
- Leukemia, Lymphocytic, Acute, B-Cell, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, B-Cell
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shenzhen Second People's HospitalUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 2 Jun 2021 (estimated)
- Study completion
- 2 Sep 2021 (estimated)
- First posted
- 26 Sep 2018 (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.
The clinical study of CART19 Cells treatment for MRD of B Cell Malignancies and then auto-HSCT
Detailed description
The clinical study of the chimeric antigen receptor T cells (CART Cells) treatment for minimal residual disease(MRD) of B Cell Malignancies and then autologous hematopoietic stem cell transplantation(auto-HSCT).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase 1 Clinical Study of CD19-directed Chimeric Antigen Receptor-modified T Cells (CART19) treatment for the Patients with Minimal Residual Disease (MRD) of B Cell Malignancies and then Autologous Hematopoietic Stem Cell Transplantation(Auto-HSCT).
| Arm | Type | Receives |
|---|---|---|
| Experimental: CART19 cell and auto-HSCT | Experimental | Biological: CART19 cell and auto-HSCTCART19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCRz:41BB administered by IV infusion. Auto-HSCT will be made about 6 mouths after CART19 cell is infused back to the patient. |
Who may qualify
- Ages
- 14 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 1. Patients with CD19+, B cell Acute Lymphocytic Leukemia(B-ALL), B cell Chronic Lymphocytic Leukemia(B-CLL), B cell Lymphoma，who have 0.01%≤MRD<10% during upfront treatment 2. Patients must be within 12 months of initial B-ALL, B-CLL, B cell Lymphoma diagnosis 3. 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 4. Age 14 years to 75 years 5. Adequate organ function defined as:
- AST and ALT ≤ 3 times upper limit of normal range for age,
- Serum creatinine ≤ 1.6 mg/dl,
- Direct bilirubin ≤2.0 mg/dl,
- Adequate pulmonary function defined as ≤ grade 2 dyspnea and ≤ grade 2 hypoxia,
Key exclusion criteria (7 listed)
- Active, uncontrolled infection
- Active hepatitis B or hepatitis C
- HIV Infection
- Class III/IV cardiovascular disability according to the New York Heart Association Classification
- Subjects with clinically apparent arrhythmia or arrhythmias who are not stable on medical management within two weeks of enrollment
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 |
|---|---|---|
| CART19 cell and auto-HSCTPhase 1 Clinical Study of CD19-directed Chimeric Antigen Receptor-modified T (CART19) Cells treatment for Adult Patient with Minimal Residual Disease(MRD) of B Cell Malignancies and then Autologous Hematopoietic Stem Cell Transplantation(Auto-HSCT). Subjects will receive 0.5-4 x 10^8 transduced CAR T cells as a split dose over three days as follows:Day 0, 10% fraction: 0.5-4x10^7 CART19 cells, Day 1, 30% fraction: 1.5x10^7-1.2x10^8 CART19 cells, Day 2, 60% fraction: 3x10^7-2.4x10^8 CART19 cells. Auto-HSCT will be made about 6 mouths after CART19 cell is infused back to the patient. | Biological | Experimental: CART19 cell and auto-HSCT |
Primary outcome
CART19 Cells Treatment of MRD of B Cell Malignancies and Then Auto-HSCT
Time frame: day 28
The incidence of conversion of minimal residual disease (MRD) to <0.01% after CART19 therapy in patients with MRD of B Cell Malignancies during upfront treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2018.
- Derived from this study: PubMed 35126471Zhou W, Chen W, Wan X, Luo C, Du X, Li X, Chen Q, Gao R, Zhang X, Xie M, Wang M. Benefits of Chimeric Antigen Receptor T-Cell Therapy for B-Cell Lymphoma. Front Genet. 2022 Jan 20;12:815679. doi: 10.3389/fgene.2021.815679. eCollection 2021.
Related trials for Leukemia, Lymphocytic, Acute, B-Cell
Recruiting
A Multicenter Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymph...
B-All, Acute Lymphoblastic Leukemia
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
RecruitingPhase 1
A Phase I Dose Finding Study of MB-CART2219.1
Lymphoma, CLL
Not yet recruiting
Venetoclax Plus Inotuzumab Reduced-Intensity Induction Sequentially Followed by Blinatumomab in B-ALL
ALL
RecruitingPhase 1
Anti-CRLF2-R/TSLPR Chimeric Antigen Receptor T Cells (TSLPR-CART) in Participants With Recurrent or Refractory CRLF2-R/TSLPR-Overexpressing B-Cell Acute Lymphoblastic Leukemia (B-ALL)
B-All, Acute Lymphoblastic Leukemia
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.
Weihong Chen, M.D., Ph.D. principal investigator
The second people's hospital of Shenzhen, The first affiliated hospital of Shenzhen University
Xin Du, M.D., Ph.D. principal investigator
The second people's hospital of Shenzhen, The first affiliated hospital of Shenzhen University
Xiaochun Wan, Ph.D. principal investigator
Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CART19 cell and auto-HSCT in people with Leukemia, Lymphocytic, Acute, B-Cell and Leukemia, Lymphocytic, Chronic, B-Cell, run by Shenzhen Second People's Hospital 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 7 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 7 Dec 2018. 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 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.
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 Weihong Chen, M.D., Ph.D. (0086-755-83366388 ext. 8199, whitney-cindy@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CART19 Cells Treatment of MRD of B Cell Malignancies and Then Auto-HSCT (time frame: day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03685786, which also lists 1 linked publication.
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 7 Dec 2018.