B-cell Acute Lymphocytic LeukemiaPhase 1/2NCT03263208
CD19 CAR-T Cells for Patients With Relapse and Refractory CD19+ B-ALL.
A Phase 1/2 study testing Cyclophosphamide, Fludarabine and CD19 CAR-T in people with B-cell Acute Lymphocytic Leukemia, run by Henan Cancer Hospital at 2 sites in China.
Trial summary
The purpose of this study is to infusion CD19 CAR-T cells to the patients with relapsed and refractory CD19+ B cell leukemia, to assess the safety and feasibility of this strategy. Read more about this study
- Who is it for?
- Ages 2 to 70 years
- Conditions the study is for
- B-cell Acute Lymphocytic Leukemia
- What is being tested?
- Cyclophosphamide, Fludarabine and CD19 CAR-T
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesChina
- Study dates
- 16 Aug 2017to Jul 2019
- 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 2 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1. 2 years to 70 years, expected survival > 3 months;
- 2. CD19 positive B-cell acute lymphoblastic leukemia;
- 3. ECOG < 2；
- 4. The tumor load in the bone marrow is less than 60%;
- 5. Cardiac function: 1-2 levels; Liver: TBIL≤3ULN，AST ≤2.5ULN，ALT ≤2.5ULN; kidney: Cr≤1.25ULN; Peripheral Blood: WBC ≥ 2.0×109/L, Hb ≥80 g/L, PLT ≥ 30×109/L）;
- 6. No leukemia cells in the central nervous system;
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- 7. No serious allergic constitution;
- 8. No other serous diseases that conflicts with the clinical program;
- 9. No other cancer history;
- 10. No serious mental disorder;
- 11. female participants of reproductive potential must have a negative serum pregnancy test;
- 12. Informed consent is signed by a subject or his lineal relation.
Who cannot join
- 1. Pregnant or lactating women;
- 2. Uncontrolled active infection, HIV infection, syphilis serology reaction positive;
- 3. Active hepatitis B or hepatitis C infection;
- 4. Recent or current use of glucocorticoid or other immunosuppressor;
- 5. With severe cardiac, liver, renal insufficiency, diabetes and other diseases;
- 6. Participate in other clinical research in the past three months; previously treatment with any gene therapy products;
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Not yet recruiting
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan
Haiping Yang, +86 13938820189, 13938820189@163.com
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan
Yongping Song, +86 13521186987, ph200811@163.com
About this study
Official title: A Study of CD19 CAR-T Cells for Patients With Relapse and Refractory CD19+ B-cell Acute Lymphoblastic Leukemia
The purpose of this study is to infusion CD19 CAR-T cells to the patients with relapsed and refractory CD19+ B cell leukemia, to assess the safety and feasibility of this strategy. The CAR enables the T cell to recognize and kill the leukemic cell through the recognition of CD19, a protein expressed of the surface of the leukemic cell in patients with CD19+ leukemia.
Read the detailed description
Upon meeting the eligibility requirements and enrolling on study, Subjects will be collected large numbers of peripheral blood mononuclear cells (PBMC) for the generation of the CD19 CAR-T cells. The T cells are isolated from the PBMC, transduced with a lentivirus to express the CD19 CAR as well as a truncated EGFR that has no signaling capacity (noted EGFRt) and expanded in vitro and then administered to subjects.
Subjects will have blood tests to assess safety and efficacy, and persistence of the CD19 CAR-T cells on week 4 after their last infusion. Following the 6 months of intensive follow-up, subjects will be evaluated every 10 weeks for 1 year with a physical examination, blood tests, bone marrow aspirate, MRD and persistence of CD19 CAR-T.
Some subjects will receive cetuximab for ablation of the genetically modified T cells. Criteria to receive cetuximab include acute toxicities that are life threatening.
- Conditions
- B-cell Acute Lymphocytic Leukemia
- Being tested
- Cyclophosphamide, Fludarabine, CD19 CAR-T
- Medical subject headings
- Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophosphamideDrug
patients will receive a standard pre-conditioning regime with cyclophosphamide 0.6-0.8g/m2/day IV for 2 days(Day-5 to day-4).
FludarabineDrug
Fludarabine 25-30mg/m2/day IV for 3 days(Day-5 to day-3).
CD19 CAR-TBiological
CD19 CAR-T cells will be administered after completion of the chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| CD19 CAR-T | Experimental | A conditioning chemotherapy regiment of fludarabine and cyclophosphamide will be administered followed by a single infusion of CAR transduced autologous T cells administered intravenously. Receives: Drug: Cyclophosphamide; Drug: Fludarabine; Biological: CD19 CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety as assessed by the occurence of study related adverse events
number of participants with adverse events
Measured: 30 days
anti-tumor responses of CD19 CAR-T cells
Measured: 1 year
Secondary outcomes (2)
Persistence of the CD19 CAR+ T cells
determine duration of in vivo survival of CD19 CAR-T cells
Measured: 1 year
Number of participants who have T cells ablated with cetuximab
The efficacy of cetuximab to ablate the T cells will be measured by loss of detection of T cells and any associated toxicities as well as facilitating B cell recovery.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2017
- Study start16 Aug 2017
- Primary completionJan 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell Acute Lymphocytic 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
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Collaborators
- The Pregene (ShenZhen) Biotechnology Company, Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03263208
- Sponsor's protocol ID
- HenanCH152
- Status last verified
- Aug 2017
- First submitted
- 24 Aug 2017
- Last updated
- 20 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of CD19 CAR-T Cells for Patients With Relapse and Refractory CD19+ B-cell Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT03263208
- Acronym / sponsor ID
- HenanCH152
- Conditions
- B-cell Acute Lymphocytic Leukemia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Collaborators
- The Pregene (ShenZhen) Biotechnology Company, Ltd.
- Study start
- 16 Aug 2017 (actual)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 28 Aug 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.
The purpose of this study is to infusion CD19 CAR-T cells to the patients with relapsed and refractory CD19+ B cell leukemia, to assess the safety and feasibility of this strategy. The CAR enables the T cell to recognize and kill the leukemic cell through the recognition of CD19, a protein expressed of the surface of the leukemic cell in patients with CD19+ leukemia.
Detailed description
Upon meeting the eligibility requirements and enrolling on study, Subjects will be collected large numbers of peripheral blood mononuclear cells (PBMC) for the generation of the CD19 CAR-T cells. The T cells are isolated from the PBMC, transduced with a lentivirus to express the CD19 CAR as well as a truncated EGFR that has no signaling capacity (noted EGFRt) and expanded in vitro and then administered to subjects.
Subjects will have blood tests to assess safety and efficacy, and persistence of the CD19 CAR-T cells on week 4 after their last infusion. Following the 6 months of intensive follow-up, subjects will be evaluated every 10 weeks for 1 year with a physical examination, blood tests, bone marrow aspirate, MRD and persistence of CD19 CAR-T.
Some subjects will receive cetuximab for ablation of the genetically modified T cells. Criteria to receive cetuximab include acute toxicities that are life threatening.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CD19 CAR-T | Experimental | Drug: Cyclophosphamide, Drug: Fludarabine, Biological: CD19 CAR-TA conditioning chemotherapy regiment of fludarabine and cyclophosphamide will be administered followed by a single infusion of CAR transduced autologous T cells administered intravenously. |
Who may qualify
- Ages
- 2 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- 1. 2 years to 70 years, expected survival > 3 months;
- 2. CD19 positive B-cell acute lymphoblastic leukemia;
- 3. ECOG < 2；
- 4. The tumor load in the bone marrow is less than 60%;
- 5. Cardiac function: 1-2 levels; Liver: TBIL≤3ULN，AST ≤2.5ULN，ALT ≤2.5ULN; kidney: Cr≤1.25ULN; Peripheral Blood: WBC ≥ 2.0×109/L, Hb ≥80 g/L, PLT ≥ 30×109/L）;
Key exclusion criteria (6 listed)
- 1. Pregnant or lactating women;
- 2. Uncontrolled active infection, HIV infection, syphilis serology reaction positive;
- 3. Active hepatitis B or hepatitis C infection;
- 4. Recent or current use of glucocorticoid or other immunosuppressor;
- 5. With severe cardiac, liver, renal insufficiency, diabetes and other 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 |
|---|---|---|
| Cyclophosphamidepatients will receive a standard pre-conditioning regime with cyclophosphamide 0.6-0.8g/m2/day IV for 2 days(Day-5 to day-4). | Drug | CD19 CAR-T |
| FludarabineFludarabine 25-30mg/m2/day IV for 3 days(Day-5 to day-3). | Drug | CD19 CAR-T |
| CD19 CAR-TCD19 CAR-T cells will be administered after completion of the chemotherapy. | Biological | CD19 CAR-T |
Primary outcome
safety as assessed by the occurence of study related adverse events
Time frame: 30 days
number of participants with adverse events
anti-tumor responses of CD19 CAR-T cells
Time frame: 1 year
2 secondary outcomes
Persistence of the CD19 CAR+ T cells
Time frame: 1 year
Number of participants who have T cells ablated with cetuximab
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2017.
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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.
2 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 Cyclophosphamide, Fludarabine and CD19 CAR-T in people with B-cell Acute Lymphocytic Leukemia, run by Henan Cancer Hospital at 2 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 12 inclusion and 6 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 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 Yongping Song (+86 13521186987, ph200811@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety as assessed by the occurence of study related adverse events (time frame: 30 days). 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 Oct 2017.