MRD-positivePhase 1NCT03919526
Anti-CD19/CD22 Bispecific Chimeric Antigen Receptor（CAR)-T Cell Therapy for Measurable Residual Disease(MRD) Positive ALL
A Phase 1 study testing anti-CD19/CD22 CAR-T cells, Fludarabine and Cyclophosphamide in people with MRD-positive and Acute Lymphoblastic Leukemia, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
To evaluate the safety and efficacy of CD19/CD22 Bispecific chimeric antigen receptor (CAR)-T for the treatment of measurable residual disaese (MRD)-positive B cell acute lymphoblastic leukemia. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- MRD-positive, Acute Lymphoblastic Leukemia
- What is being tested?
- anti-CD19/CD22 CAR-T cells, Fludarabine and Cyclophosphamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteChina
- Study dates
- 11 Aug 2019to 1 Nov 2023
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) CD19 positive/CD22 positive, or CD19-CD22 positive B-cell acute lymphoblastic leukemia;
- (2)18 to 70 Years Old, Male and female;
- (3) Expected survival > 12 weeks;
- (4) ECOG score 0-2;
- (5) Bone marrow examination clearly diagnosed as B-cell acute lymphoblastic leukemia and who met one of the following conditions:
- Recurrent patients who achieves MRD-positive CR or CRi after standard therapy;
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- Those who achieves CR, but failed to achieve MRD-negative after at least 2 courses of consolidation therapy;
- For Ph-positive ALL patients, a history of at least one TKI application is required in addition to two standard chemotherapy treatments
- (6) The venous access required for collection can be established and mononuclear cell collection can be determined by the investigators;
- (7) Liver, kidney and cardiopulmonary functions meet the following requirements:
- Creatinine is in the normal range;
- Left ventricular ejection fraction >50%;
- Baseline oxygen saturation>92%;
- Total bilirubin ≤ 2×ULN;
- ALT and AST ≤ 2.5×ULN;
- (8) Able to understand and sign the Informed Consent Document.
Who cannot join
- (1) Malignant tumors other than acute lymphoblastic leukemia within 5 years prior to screening, in addition to adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical resection, and ductal carcinoma in situ after radical resection;
- (2) Subjects with positive HBsAg or HBcAb and peripheral blood HBV DNA titer detection ≥ 1 × 102 copy number / L; HCV antibody positive and peripheral blood HCV RNA positive; HIV antibody positive; CMV DNA positive; syphilis positive;
- (3) Any instability of systemic disease, including but not limited to unstable angina, cerebrovascular accident, or transient cerebral ischemic (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), congestive heart failure (New York heart association (NYHA) classification ≥ III), need drug therapy of severe arrhythmia, liver, kidney, or metabolic disease;
- (4) Active or uncontrollable infection requiring systemic therapy within 14 days prior to enrollment;
- (5) Pregnant or lactating woman, and female subject who plans to have a pregnancy within 1 year after cell transfusion, or male subject whose partner plans to have a pregnancy within 1 year after cell transfusion;
- (6) Received CAR-T treatment or other gene therapies before enrollment;
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- (7) Patients with symptoms of central nervous system;
- (8) Subjects who are receiving systemic steroid treatment and requiring long-term systemic steroid treatment during the treatment as determined by the investigator before screening (except inhalation or topical use); And subjects treated with systemic steroids (except inhalation or topical use) within 72h prior to cell transfusion;
- (9) The investigators consider other conditions unsuitable for enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Safety and Clinical Efficacy of Human CD19/CD22 Bispecific Chimeric Antigen Receptor (CAR)-T Cell Therapy for Subjects With Measurable Residual Disease(MRD)-Positive B Cell Acute Lymphoblastic Leukemia
To evaluate the safety and efficacy of CD19/CD22 Bispecific chimeric antigen receptor (CAR)-T for the treatment of measurable residual disaese (MRD)-positive B cell acute lymphoblastic leukemia. Patients will be given a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of CD19/CD22 CAR+ T cells.
Read the detailed description
Participants with MRD-positive B cell acute lymphoblastic leukemia can participate if all eligibility criteria are met. Tests required to determine eligibility include disease assessments, a physical exam, Electrocardiograph, CT/MRI , and blood draws. Participants receive chemotherapy prior to the infusion of CD19/CD22 CAR+ T cells. After the infusion, participants will be followed for side effects and effect of CD19/CD22 CAR+ T cells. Study procedures may be performed while hospitalized.
- Conditions
- MRD-positive, Acute Lymphoblastic Leukemia
- Being tested
- anti-CD19/CD22 CAR-T cells, Fludarabine, Cyclophosphamide
- Keywords
- CD19/CD22, Bispecific CAR-T, leukemia, MRD-positive, B-ALL
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-CD19/CD22 CAR-T cellsBiological
Retroviral vector-transduced autologous T cells to express anti-CD19 and anti-CD22 CARs
FludarabineDrug
30mg/m2/d
CyclophosphamideDrug
300mg/m2/d
| Study group | Role | What they receive |
|---|---|---|
| anti-CD19/CD22 CAR-T cells | Experimental | Administration with anti-CD19/ CD22 CAR-T cells in the MRD-positive ALL patients. Receives: Biological: anti-CD19/CD22 CAR-T cells; Drug: Fludarabine; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety measured by occurence of study related adverse effects defined by NCI CTCAE5.0
Safety measured by occurence of study related adverse effects defined by NCI CTCAE5.0
Measured: 28 days post infusion
Secondary outcomes (6)
MRD clearance
MRD clearance
Measured: 3 months post infusion
Content of CD19 positive B-cells in peripheral blood
Content of CD19 positive B-cells in peripheral blood
Measured: 3 months post infusion
Content of CAR-T related cytokines positive T cells in circulation
Content of CAR-T related cytokines positive T cells in circulation
Measured: 3 months post infusion
Total response rate (ORR) after administration
Total response rate (ORR) after administration including complete response(CR) and partial response(PR)
Measured: 3 months post infusion
Duration of remission (DOR) after administration
Duration of remission (DOR) after administration
Measured: 2 years post infusion
Overall Survival (OS)after administration
Overall Survival (OS)after administration
Measured: 2 years post infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2019
- Study start11 Aug 2019
- Primary completion1 Nov 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MRD-positiveStudies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xianmin Song, MD, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Xianmin Song, M.D., Principal investigator, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03919526
- Sponsor's protocol ID
- SHSYXY-CAR-T MRD+ALL
- Status last verified
- Dec 2023
- First submitted
- 7 Apr 2019
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Clinical Efficacy of Human CD19/CD22 Bispecific Chimeric Antigen Receptor (CAR)-T Cell Therapy for Subjects With Measurable Residual Disease(MRD)-Positive B Cell Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT03919526
- Acronym / sponsor ID
- SHSYXY-CAR-T MRD+ALL
- Conditions
- MRD-positive, Acute Lymphoblastic Leukemia
- Keywords
- CD19/CD22, Bispecific CAR-T, leukemia, MRD-positive, B-ALL
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 11 Aug 2019 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 18 Apr 2019 (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.
To evaluate the safety and efficacy of CD19/CD22 Bispecific chimeric antigen receptor (CAR)-T for the treatment of measurable residual disaese (MRD)-positive B cell acute lymphoblastic leukemia. Patients will be given a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of CD19/CD22 CAR+ T cells.
Detailed description
Participants with MRD-positive B cell acute lymphoblastic leukemia can participate if all eligibility criteria are met. Tests required to determine eligibility include disease assessments, a physical exam, Electrocardiograph, CT/MRI , and blood draws. Participants receive chemotherapy prior to the infusion of CD19/CD22 CAR+ T cells. After the infusion, participants will be followed for side effects and effect of CD19/CD22 CAR+ T cells. Study procedures may be performed while hospitalized.
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/CD22 CAR-T cells | Experimental | Biological: anti-CD19/CD22 CAR-T cells, Drug: Fludarabine, Drug: CyclophosphamideAdministration with anti-CD19/ CD22 CAR-T cells in the MRD-positive ALL patients. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- (1) CD19 positive/CD22 positive, or CD19-CD22 positive B-cell acute lymphoblastic leukemia;
- (2)18 to 70 Years Old, Male and female;
- (3) Expected survival > 12 weeks;
- (4) ECOG score 0-2;
- (5) Bone marrow examination clearly diagnosed as B-cell acute lymphoblastic leukemia and who met one of the following conditions:
Key exclusion criteria (9 listed)
- (1) Malignant tumors other than acute lymphoblastic leukemia within 5 years prior to screening, in addition to adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical resection, and ductal carcinoma in situ after radical resection;
- (2) Subjects with positive HBsAg or HBcAb and peripheral blood HBV DNA titer detection ≥ 1 × 102 copy number / L; HCV antibody positive and peripheral blood HCV RNA positive; HIV antibody positive; CMV DNA positive; syphilis positive;
- (3) Any instability of systemic disease, including but not limited to unstable angina, cerebrovascular accident, or transient cerebral ischemic (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), congestive heart failure (New York heart association (NYHA) classification ≥ III), need drug therapy of severe arrhythmia, liver, kidney, or metabolic disease;
- (4) Active or uncontrollable infection requiring systemic therapy within 14 days prior to enrollment;
- (5) Pregnant or lactating woman, and female subject who plans to have a pregnancy within 1 year after cell transfusion, or male subject whose partner plans to have a pregnancy within 1 year after cell transfusion;
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 |
|---|---|---|
| anti-CD19/CD22 CAR-T cellsRetroviral vector-transduced autologous T cells to express anti-CD19 and anti-CD22 CARs | Biological | anti-CD19/CD22 CAR-T cells |
| Fludarabine30mg/m2/d | Drug | anti-CD19/CD22 CAR-T cells |
| Cyclophosphamide300mg/m2/d | Drug | anti-CD19/CD22 CAR-T cells |
Primary outcome
Safety measured by occurence of study related adverse effects defined by NCI CTCAE5.0
Time frame: 28 days post infusion
Safety measured by occurence of study related adverse effects defined by NCI CTCAE5.0
6 secondary outcomes
MRD clearance
Time frame: 3 months post infusion
Content of CD19 positive B-cells in peripheral blood
Time frame: 3 months post infusion
Content of CAR-T related cytokines positive T cells in circulation
Time frame: 3 months post infusion
Total response rate (ORR) after administration
Time frame: 3 months post infusion
Duration of remission (DOR) after administration
Time frame: 2 years post infusion
Overall Survival (OS)after administration
Time frame: 2 years post infusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- 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.
Xianmin Song, M.D. principal investigator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
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 anti-CD19/CD22 CAR-T cells, Fludarabine and Cyclophosphamide in people with MRD-positive and Acute Lymphoblastic Leukemia, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine 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 16 inclusion and 9 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: finished, as of the sponsor's last update on 8 Dec 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety measured by occurence of study related adverse effects defined by NCI CTCAE5.0 (time frame: 28 days post infusion). 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 8 Dec 2023.