Acute Lymphoblastic LeukemiaPhase 2NCT03902197
CD19 hsCAR-T for Refractory/Relapsed CD19+ B-ALL Patients
A Phase 2 study testing CD19 hsCAR-T in people with Acute Lymphoblastic Leukemia, run by Xuanwu Hospital, Beijing at 2 sites in China.
Trial summary
This Phase II study is to evaluate the efficacy and safety of a CD19-targeting humanized selective CAR-T (CD19 hsCAR-T) in refractory/relapsed CD19+ B-ALL leukemia patients who have no available curative treatment options, have a limited prognosis with currently available treatments, and were previously treated with a… Read more about this study
- Who is it for?
- Ages 1 year to 75 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- CD19 hsCAR-T
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesChina
- Study dates
- 22 Apr 2019to 21 Dec 2023
- Phase
- Phase 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 1 year to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects with refractory/relapse B-cell ALL with no available curative treatment options (such as autologous or allogeneic SCT);
- Subjects previously treated with B cell-directed engineered cell therapy are eligible if they meet the following criteria:
- relapsed and/or MRD-positive after prior cell therapy;
- partial response to prior cell therapy;
- Clinical and laboratory data are available;
- Documented CD19 expression after previous B cell-directed therapies;
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- Aged 1 to 75 years;
- KPS>40；
- At least 2 weeks or 5 drug half-lives, whichever is shorter must have elapsed since any prior systemic therapy at the time the subject is planned for leukapheresis, except for systemic inhibitory/stimulatory immune checkpoint therapy;
- Women of childbearing potential must have a urine pregnancy test taken and proven negative prior to the treatment. All patients agree to use reliable methods of contraception during the trial period and throughout the last follow-up visit;
- Subjects with relapsed disease after prior allogeneic SCT (myeloablative or non-myeloablative) will be eligible if the patients do not present with active GVHD and are not undergoing immunosuppressive regimes;
- Patients with CNS3 (WCB ≥5/mL in CSF with presence of lymphoblasts) disease will be eligible if the CNS disease is responsive to therapy;
- Participation in the clinical trials should be voluntary with signed informed consent.
Who cannot join
- Patients with hypervolemia (white blood cell count> 50 x 10^9 / L) or rapidly progressive disease that in the estimation of the investigators and sponsors would compromise the patient's ability to complete the study;
- History of melanoma skin cancer or other primary tumors (eg, cervical cancer, bladder cancer, breast cancer) (except for those with 3 years or longer of cure);
- Patients with fungal, bacterial, viral, or other uncontrollable infections or infections requiring Level 4 isolation (UTI or inoculation assays may be performed if necessary);
- Patients with positive results for HIV, HBV, HCV tests;
- With CNS disorders such as cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or autoimmune disease with CNS involvement;
- History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac diseases within 12 months of enrollment, or with cardiac atrial or cardiac ventricular lymphoma;
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- Patients that are receiving anticoagulant therapy or have ever coagulation disorders;
- Any medical condition that in the judgment of the sponsors/investigators is likely to interfere with assessment of safety or efficacy of study;
- History of severe immediate hypersensitivity reaction to any of the agents used in this study;
- Female patients who are pregnant or breastfeeding;
- Feasibility assessment during screening demonstrates <30% transduction of target lymphocytes, or insufficient expansion (< 5-fold) in response to CD3/CD28 co-stimulation;
- Patients with any uncontrolled diseases that are unsuitable for enrollment;
- CNS3 disease that is progressive on therapy, or with CNS parenchymal lesions that might increase the risk of CNS toxicity;
- Any situation that is considered to potentially increase the risk of the subject or interfere with the outcome of the study;
- Patients who have been enrolled in other clinical studies.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Beijing Children's Hospital Capital Meidcal University
Beijing, Beijing Municipality
Huyong Zheng, MD, PhD
- Recruiting
Beijing Children's Hospital, Capital Medical University
Beijing, Beijing Municipality
Huyong Zheng, MD, PhD
Zhiguo Chen, PhD
About this study
Official title: A Phase II Study of CD19 hsCAR-T for Refractory/Relapsed CD19+ B-ALL Patients Previously Treated With Cell Therapy
This Phase II study is to evaluate the efficacy and safety of a CD19-targeting humanized selective CAR-T (CD19 hsCAR-T) in refractory/relapsed CD19+ B-ALL leukemia patients who have no available curative treatment options, have a limited prognosis with currently available treatments, and were previously treated with a B cell directed cell therapy.
Read the detailed description
CD19+ B-ALL patients who have relapsed after murine-based CD19 CAR-T (CD19mCAR-T) treatment and/or have limited clinical response to CD19mCAR-T will be enrolled to receive CD19 hsCAR-T treatment.
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- CD19 hsCAR-T
- Keywords
- CD19 hsCAR-T, B-ALL, Humanized selective CAR
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD19 hsCAR-TBiological
CD19 hsCAR-T will be administered by I.V. infusion
| Study group | Role | What they receive |
|---|---|---|
| CD19 hsCAR-T | Experimental | This cohort will be administrated by T cells transduced with lentivirus vectors expressing CD19 hsCAR Receives: Biological: CD19 hsCAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR) within 3 months
Overall response rate (ORR) within 3 months after infusion of CD19 hsCAR-T
Measured: 3 months
Secondary outcomes (4)
Best overall response (BOR)
Best overall response (BOR) of complete remission (CR) or CR with incomplete blood count recovery (CRi) within 3 months after CD19 hsCAR-T infusion
Measured: 3 months
Duration of remission (DoR)
Duration of remission (DoR) within 1 year after CD19 hsCAR-T infusion (Duration of remission (DOR) is defined as the duration from the date when the response criteria of CR or CRi is first met to the date of relapse or death due to ALL)
Measured: 1 year
Event free survival within 1 year
Event free survival within 1 year (Event free survival is defined as the time from start of the first infusion to the earliest of death from any cause or relapse)
Measured: 1 year
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])
Safety and tolerability of CD19 hsCAR-T: frequency and severity of adverse events, including, but not limited to, cytokine release syndrome (CRS) and macrophage activation syndrome (MAS)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start22 Apr 2019 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion21 Dec 2023 (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.
- More trials run by Xuanwu Hospital, BeijingThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Zhiguo Chen, PhD, Principal investigator, Xuanwu Hospital, BeijingHuyong Zheng, MD, PhD, Principal investigator, Beijing Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03902197
- Sponsor's protocol ID
- CD19hsCAR20190401
- Status last verified
- Mar 2019
- First submitted
- 1 Apr 2019
- Last updated
- 8 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of CD19 hsCAR-T for Refractory/Relapsed CD19+ B-ALL Patients Previously Treated With Cell Therapy
- ClinicalTrials.gov ID
- NCT03902197
- Acronym / sponsor ID
- CD19hsCAR20190401
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- CD19 hsCAR-T, B-ALL, Humanized selective CAR
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Collaborators
- Beijing Children's Hospital
- Study start
- 22 Apr 2019 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 21 Dec 2023 (estimated)
- First posted
- 3 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.
This Phase II study is to evaluate the efficacy and safety of a CD19-targeting humanized selective CAR-T (CD19 hsCAR-T) in refractory/relapsed CD19+ B-ALL leukemia patients who have no available curative treatment options, have a limited prognosis with currently available treatments, and were previously treated with a B cell directed cell therapy.
Detailed description
CD19+ B-ALL patients who have relapsed after murine-based CD19 CAR-T (CD19mCAR-T) treatment and/or have limited clinical response to CD19mCAR-T will be enrolled to receive CD19 hsCAR-T treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CD19 hsCAR-T | Experimental | Biological: CD19 hsCAR-TThis cohort will be administrated by T cells transduced with lentivirus vectors expressing CD19 hsCAR |
Who may qualify
- Ages
- 1 year to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- Subjects with refractory/relapse B-cell ALL with no available curative treatment options (such as autologous or allogeneic SCT);
- Subjects previously treated with B cell-directed engineered cell therapy are eligible if they meet the following criteria:
- Documented CD19 expression after previous B cell-directed therapies;
- Aged 1 to 75 years;
- KPS>40；
Key exclusion criteria (15 listed)
- Patients with hypervolemia (white blood cell count> 50 x 10^9 / L) or rapidly progressive disease that in the estimation of the investigators and sponsors would compromise the patient's ability to complete the study;
- History of melanoma skin cancer or other primary tumors (eg, cervical cancer, bladder cancer, breast cancer) (except for those with 3 years or longer of cure);
- Patients with fungal, bacterial, viral, or other uncontrollable infections or infections requiring Level 4 isolation (UTI or inoculation assays may be performed if necessary);
- Patients with positive results for HIV, HBV, HCV tests;
- With CNS disorders such as cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or autoimmune disease with CNS involvement;
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 |
|---|---|---|
| CD19 hsCAR-TCD19 hsCAR-T will be administered by I.V. infusion | Biological | CD19 hsCAR-T |
Primary outcome
Overall response rate (ORR) within 3 months
Time frame: 3 months
Overall response rate (ORR) within 3 months after infusion of CD19 hsCAR-T
4 secondary outcomes
Best overall response (BOR)
Time frame: 3 months
Duration of remission (DoR)
Time frame: 1 year
Event free survival within 1 year
Time frame: 1 year
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2019.
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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.
Zhiguo Chen, PhD principal investigator
Xuanwu Hospital, Beijing
Huyong Zheng, MD, PhD principal investigator
Beijing Children's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CD19 hsCAR-T in people with Acute Lymphoblastic Leukemia, run by Xuanwu Hospital, Beijing 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 13 inclusion and 15 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 8 Apr 2019. 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 phase mean?
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 Zhiguo Chen, PhD (86-10-83198889, chenzhiguo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) within 3 months (time frame: 3 months). 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 Apr 2019.