Refractory B Acute Lymphoblastic LeukemiaPhase 1NCT04094766
Safety and Efficacy of Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy in R/R Acute B Lymphoblastic Leukemia
A Phase 1 study testing Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy in people with Refractory B Acute Lymphoblastic Leukemia and Relapse B Acute Lymphoblastic Leukemia, run by Second Affiliated Hospital of Xi'an Jiaotong University at 1 site in China.
Trial summary
This is a single arm, open-label, dose escalation clinical study to evaluate the safety and efficacy of infusion of dual specificity CD19 and CD22 CAR-T cells in patients with relapsed and refractory acute B lymphoblastic leukemia. Read more about this study
- Who is it for?
- Ages 14 to 60 years
- Conditions the study is for
- Refractory B Acute Lymphoblastic Leukemia, Relapse B Acute Lymphoblastic Leukemia
- What is being tested?
- Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2017to 30 Aug 2020
- 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 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Written informed consent could be acquired;
- Diagnosed with relapse/refractory acute lymphoblastic leukemia;
- Relapse was defined as recurrence of blast cell(more than 5%) in peripheral blood or in bone marrow or extramedullary involvement;
- Refractory was defined as failed to achieve complete remission after two courses of induction therapy;
- CD19/CD22 postive leukemia cell was confirmed by flow cytometry or immunohistochemistry within 90 days since enrollment in this trial;
- Karnofsky score ≥70;
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- Results of pregnant test should be negative, and agree to conception control during treatment and 6 months after CAR-T infusion.
- Adequate organ function: EF≥50%; normal ECG; CCR ≥ 50ml/min or Cr < 2.0mg/dL or < 2 times upper limitation of normal; ALT and AST<5 times upper limitation of normal; Serum bilirubin ≤ 3.0mg/dL; DLCO or FEV1 > 45% of predict value;
- At least 2 weeks intervals since the last chemotherapy;
- At least 2 weeks intervals since the last anti-GVHD therapy if patients have ever ;
Who cannot join
- Patients diagnosed with acute promyelocytic leukemia:t(15;17)(q22;q12);
- Women in pregnancy and lactation;
- Uncontrolled infection, Active HBV or HCV infection, HIV positive or any other deadly bacterial/virual diseases;
- Long term use of systemic corticosteroids(5mg per day for 2 weeks);
- Any other uncontrolled life-threaten diseases;
- Patients with history of anaphylaxis to any drugs;
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- With central nervous system (CNS) involvement;
- Patients with GVHD after allo-HSCT who needed immunosuppressive agents ;
- Patients with acute autoimmune diseases such as psoriasis or rheumatoid arthritis;
- Other conditions that principle investigator considered may increase the risk of the patients or interference the results.
Trial locations and contacts
1 site in 1 country.
China1 site
Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710000
About this study
Official title: A Phase I Clinical Study of Dual Specificity CD19 and CD22 Chimeric Antigen Receptor T Cell Therapy in Relapsed or Refractory Acute B Lymphoblastic Leukemia
This is a single arm, open-label, dose escalation clinical study to evaluate the safety and efficacy of infusion of dual specificity CD19 and CD22 CAR-T cells in patients with relapsed and refractory acute B lymphoblastic leukemia.
Read the detailed description
CD19-directed CAR-T cell therapy has shown promising results for the treatment of relapsed or refractory acute B lymphoblastic leukemia. CD19 and CD22 are proteins usually expressed on the surface of the B leukemia cells. The dual specificity CAR enables the T-cells to recognize and kill the tumor cell through recognition of CD19 and CD22.
- Being tested
- Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy
- Keywords
- Chimeric Antigen Receptor T cells, CD19 and CD22
- Medical subject headings
- Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual Specificity CD19 and CD22 CAR-T Cell ImmunotherapyDrug
Patients will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of CAR-T cells. After a pre-treatment lymphodepletion therapy, patients will receive the Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy by intravenous injection.
| Study group | Role | What they receive |
|---|---|---|
| BLLCAR-L10D treatment group | Experimental | In BLLCAR-L10D treatment group, patients will be treated with dual specificity CD19 and CD22 CAR-T cells with a escalation approach, 3 CAR-T dosage will be tested in this study: 0.5×10^6, 1.5×10^6, 2.0×10^6 CAR-T cells/kg. Receives: Drug: Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of treatment related adverse events
Assessed by CTCAE v4.0
Measured: Day 1-100 days after injection
Secondary outcomes (3)
Objective response rate
Objective response include complete remission and partial remission
Measured: Day 1-5 years after injection
Overall survival
Measured: Day 1-5 years after injection
Progression free survival
Measured: Day 1-5 years after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start1 Aug 2017
- Primary completion30 Aug 2020 (estimated)
- Study completion30 Aug 2020 (estimated)
Why it stopped: Production plan adjustment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory B 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Collaborators
- Nanjing Legend Biotech Co.
- Responsible party
- Sponsor
- Investigators
- Aili He, MD, PhD, Principal investigator, Second Affiliated Hospital of Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04094766
- Sponsor's protocol ID
- XJTU-BLLCAR-L10D
- Status last verified
- Nov 2020
- First submitted
- 17 Sep 2019
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- 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 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study of Dual Specificity CD19 and CD22 Chimeric Antigen Receptor T Cell Therapy in Relapsed or Refractory Acute B Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT04094766
- Acronym / sponsor ID
- XJTU-BLLCAR-L10D
- Keywords
- Chimeric Antigen Receptor T cells, CD19 and CD22
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Production plan adjustment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- Nanjing Legend Biotech Co.
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 30 Aug 2020 (estimated)
- Study completion
- 30 Aug 2020 (estimated)
- First posted
- 19 Sep 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.
This is a single arm, open-label, dose escalation clinical study to evaluate the safety and efficacy of infusion of dual specificity CD19 and CD22 CAR-T cells in patients with relapsed and refractory acute B lymphoblastic leukemia.
Detailed description
CD19-directed CAR-T cell therapy has shown promising results for the treatment of relapsed or refractory acute B lymphoblastic leukemia. CD19 and CD22 are proteins usually expressed on the surface of the B leukemia cells. The dual specificity CAR enables the T-cells to recognize and kill the tumor cell through recognition of CD19 and CD22.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BLLCAR-L10D treatment group | Experimental | Drug: Dual Specificity CD19 and CD22 CAR-T Cell ImmunotherapyIn BLLCAR-L10D treatment group, patients will be treated with dual specificity CD19 and CD22 CAR-T cells with a escalation approach, 3 CAR-T dosage will be tested in this study: 0.5×10^6, 1.5×10^6, 2.0×10^6 CAR-T cells/kg. |
Who may qualify
- Ages
- 14 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Written informed consent could be acquired;
- Diagnosed with relapse/refractory acute lymphoblastic leukemia;
- Relapse was defined as recurrence of blast cell(more than 5%) in peripheral blood or in bone marrow or extramedullary involvement;
- Refractory was defined as failed to achieve complete remission after two courses of induction therapy;
- CD19/CD22 postive leukemia cell was confirmed by flow cytometry or immunohistochemistry within 90 days since enrollment in this trial;
Key exclusion criteria (10 listed)
- Patients diagnosed with acute promyelocytic leukemia:t(15;17)(q22;q12);
- Women in pregnancy and lactation;
- Uncontrolled infection, Active HBV or HCV infection, HIV positive or any other deadly bacterial/virual diseases;
- Long term use of systemic corticosteroids(5mg per day for 2 weeks);
- Any other uncontrolled life-threaten diseases;
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 |
|---|---|---|
| Dual Specificity CD19 and CD22 CAR-T Cell ImmunotherapyPatients will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of CAR-T cells. After a pre-treatment lymphodepletion therapy, patients will receive the Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy by intravenous injection. | Drug | BLLCAR-L10D treatment group |
Primary outcome
Occurrence of treatment related adverse events
Time frame: Day 1-100 days after injection
Assessed by CTCAE v4.0
3 secondary outcomes
Objective response rate
Time frame: Day 1-5 years after injection
Overall survival
Time frame: Day 1-5 years after injection
Progression free survival
Time frame: Day 1-5 years after injection
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
- 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.
Aili He, MD, PhD principal investigator
Second Affiliated Hospital of Xi'an Jiaotong University
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 Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy in people with Refractory B Acute Lymphoblastic Leukemia and Relapse B Acute Lymphoblastic Leukemia, run by Second Affiliated Hospital of Xi'an Jiaotong University 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 10 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: withdrawn, as of the sponsor's last update on 5 Nov 2020. 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 was withdrawn before enrolling participants, so there are no results.
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?
Occurrence of treatment related adverse events (time frame: Day 1-100 days after injection). 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 5 Nov 2020.