Acute Lymphoblastic LeukemiaPhase 1/2NCT03366324
Anti-CD19 CAR-T Therapy Combine With HSCT to Treat MRD+ B-cell Malignancies
A Phase 1/2 study testing Second generation CAR-T cells and Hematological stem cell transplantation in people with Acute Lymphoblastic Leukemia and B Cell Lymphoma, run by Wuhan Sian Medical Technology Co., Ltd at 1 site in China.
Trial summary
For micro residual disease (MRD) positive patients who have undergone at least 2 cycles chemotherapies for their CD19+ B-cell malignancies, there would be much more risks for them to receive hematological stem cell transplantation (HSCT) than MRD- patients. Read more about this study
- Who is it for?
- Ages Up to 70 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia, B Cell Lymphoma
- What is being tested?
- Second generation CAR-T cells and Hematological stem cell transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2016to 1 Jun 2021
- 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 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The patient is pathologically and histologically confirmed as CD19 + B cell tumors, and has no effective treatment options currently, such as chemotherapy or autologous hematopoietic stem cell transplantation (auto-HSCT); or patients voluntarily choose CD19 CAR-T cells as a first treatment;
- The patient is MRD+ (<10%) after at least two cycles of chemotherapies.
- B cell hematological malignancies include the following three categories:
- B-cell acute lymphocytic leukemia (B-ALL);
- Indolent B-cell lymphoma (CLL, FL, MZL, LPL);
- Aggressive B-cell lymphoma (DLBCL, BL, MCL);
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- < 70 years old;
- Expected survival time > 6 months;
- Female patients around childbearing age, negative pregnancy test before trial, and agreed to take effective contraceptive measures during the trial until the last visit;
- Voluntarily participate in this experiment and sign informed consent by themselves, or legally authorized representative.
Who cannot join
- With a history of allo-HSCT;
- With a history of epilepsy or other central nervous system diseases;
- The presence of clinically significant cardiovascular disease, such as uncontrolled or symptomatic arrhythmias, congestive heart failure or myocardial infarction within recent six months, or heart disease with cardiac function in any grade 3 (moderate) or 4 ( severe) (according to the New York Heart Association (NYHA) Functional Classification System);
- Pregnant or lactating women (safety of this therapy for the unborn child is unknown);
- Not curable active infection;
- Patients with active hepatitis B or hepatitis C virus infection;
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- Combined use of systemic steroids within two weeks (except use of inhaled steroid recently or currently);
- Using product of gene therapy before;
- Creatinine> 2.5 mg / dl (221.0 umol/L); ALT / AST> 3 X the normal amount; Bilirubin> 2.0 mg / dl (34.2 umol/L);
- Patients suffering from other uncontrolled diseases, and researchers believe that the patient is not suitable for trial;
- Patients with HIV-infection;
- Any situation that may increase the risk of patients or interfere with test results.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Institute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
YU HU, M.D., Ph.D, 86-13986183871, dr_huyu@126.com
HENG MEI, M.D., Ph.D, 86-13886160811, mayheng@126.com
About this study
Official title: A Phase 1/2 Study Evaluating the Safety and Efficacy of the Combination of Anti-CD19 Chimeric Antigen Receptor-Modified T Cell (CAR-T) Therapy and Hematological Stem Cell Transplantation (HSCT) for MRD+ B-cell Malignancies
For micro residual disease (MRD) positive patients who have undergone at least 2 cycles chemotherapies for their CD19+ B-cell malignancies, there would be much more risks for them to receive hematological stem cell transplantation (HSCT) than MRD- patients. In order to reduce HSCT-related adverse events for these kind of patients, investigators plan to conduct CAR-T therapies on them first to make them achieve MRD- statuses, and then transfer them to HSCT.
Read the detailed description
In order to improve prognoses for MRD+ patients who have undergone at least 2 cycles chemotherapies, patients will receive CAR-T therapy before HSCT, once they achieve MRD- remissions, they will subsequently receive HSCT if there are no contraindications.
- Conditions
- Acute Lymphoblastic Leukemia, B Cell Lymphoma
- Being tested
- Second generation CAR-T cells, Hematological stem cell transplantation
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Second generation CAR-T cellsGenetic
Patients receive CD19 CAR-T cells transduced with a lentiviral vector on days 0, 1, and 2.
Hematological stem cell transplantationProcedure or surgery
Patients receive hematological stem cell transplantations within 3 months after they achieve MRD- remissions after CAR-T therapies.
| Study group | Role | What they receive |
|---|---|---|
| Combination of CAR-T therapy and HSCT | Experimental | After patients achieve MRD- remissions through Second generation CAR-T cells, they will subsequently receive hematological stem cell transplantations within 30 days. Receives: Genetic: Second generation CAR-T cells; Procedure: Hematological stem cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of study related adverse events
defined as >= Grade 3（NCI CTCAE version 4.03） signs/symptoms, laboratory toxicities, and clinical events that are possibly, likely, or definitely related to study treatment
Measured: 200 days from enrollment
Secondary outcomes (1)
Number of participants with an MRD negative complete remission after CAR-T therapy and HSCT
the efficacy of the combination of CAR-T therapy and HSCT will be estimated based on the number of participants who have an MRD negative (flow cytometry) bone marrow aspirate following the treatment
Measured: 2 years from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2017
- Study start1 May 2016
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The only one group of patients will receive the combination of CAR-T therapy and HSCT.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuhan Sian Medical Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Jingzhou Central Hospital, Xiangyang Central Hospital, The First People's Hospital of Yuhang District
- Responsible party
- Sponsor
- Investigators
- YU HU, M.D., Ph.D, Principal investigator, Institute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03366324
- Sponsor's protocol ID
- CART-CD19-03
- Status last verified
- Nov 2018
- First submitted
- 1 Dec 2017
- Last updated
- 20 Nov 2018
- Results posted
- No
- 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 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study Evaluating the Safety and Efficacy of the Combination of Anti-CD19 Chimeric Antigen Receptor-Modified T Cell (CAR-T) Therapy and Hematological Stem Cell Transplantation (HSCT) for MRD+ B-cell Malignancies
- ClinicalTrials.gov ID
- NCT03366324
- Acronym / sponsor ID
- CART-CD19-03
- Conditions
- Acute Lymphoblastic Leukemia, B Cell Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Wuhan Sian Medical Technology Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Jingzhou Central Hospital, Xiangyang Central Hospital, The First People's Hospital of Yuhang District
- Study start
- 1 May 2016 (actual)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 8 Dec 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.
For micro residual disease (MRD) positive patients who have undergone at least 2 cycles chemotherapies for their CD19+ B-cell malignancies, there would be much more risks for them to receive hematological stem cell transplantation (HSCT) than MRD- patients. In order to reduce HSCT-related adverse events for these kind of patients, investigators plan to conduct CAR-T therapies on them first to make them achieve MRD- statuses, and then transfer them to HSCT.
Detailed description
In order to improve prognoses for MRD+ patients who have undergone at least 2 cycles chemotherapies, patients will receive CAR-T therapy before HSCT, once they achieve MRD- remissions, they will subsequently receive HSCT if there are no contraindications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The only one group of patients will receive the combination of CAR-T therapy and HSCT.
| Arm | Type | Receives |
|---|---|---|
| Combination of CAR-T therapy and HSCT | Experimental | Genetic: Second generation CAR-T cells, Procedure: Hematological stem cell transplantationAfter patients achieve MRD- remissions through Second generation CAR-T cells, they will subsequently receive hematological stem cell transplantations within 30 days. |
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- The patient is pathologically and histologically confirmed as CD19 + B cell tumors, and has no effective treatment options currently, such as chemotherapy or autologous hematopoietic stem cell transplantation (auto-HSCT); or patients voluntarily choose CD19 CAR-T cells as a first treatment;
- The patient is MRD+ (<10%) after at least two cycles of chemotherapies.
- B cell hematological malignancies include the following three categories:
- < 70 years old;
- Expected survival time > 6 months;
Key exclusion criteria (12 listed)
- With a history of allo-HSCT;
- With a history of epilepsy or other central nervous system diseases;
- The presence of clinically significant cardiovascular disease, such as uncontrolled or symptomatic arrhythmias, congestive heart failure or myocardial infarction within recent six months, or heart disease with cardiac function in any grade 3 (moderate) or 4 ( severe) (according to the New York Heart Association (NYHA) Functional Classification System);
- Pregnant or lactating women (safety of this therapy for the unborn child is unknown);
- Not curable active infection;
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 |
|---|---|---|
| Second generation CAR-T cellsPatients receive CD19 CAR-T cells transduced with a lentiviral vector on days 0, 1, and 2. | Genetic | Combination of CAR-T therapy and HSCT |
| Hematological stem cell transplantationPatients receive hematological stem cell transplantations within 3 months after they achieve MRD- remissions after CAR-T therapies. | Procedure or surgery | Combination of CAR-T therapy and HSCT |
Primary outcome
Occurrence of study related adverse events
Time frame: 200 days from enrollment
defined as >= Grade 3（NCI CTCAE version 4.03） signs/symptoms, laboratory toxicities, and clinical events that are possibly, likely, or definitely related to study treatment
1 secondary outcome
Number of participants with an MRD negative complete remission after CAR-T therapy and HSCT
Time frame: 2 years from enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2018.
- 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.
YU HU, M.D., Ph.D principal investigator
Institute of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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 Second generation CAR-T cells and Hematological stem cell transplantation in people with Acute Lymphoblastic Leukemia and B Cell Lymphoma, run by Wuhan Sian Medical Technology 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 12 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 Nov 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 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 YU HU, M.D., Ph.D (86-13986183871, dr_huyu@126.com), 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: 200 days from 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 20 Nov 2018; AzTrials last refreshed its copy on 8 Nov 2026.