B-cell Acute Lymphoblastic LeukemiaPhase 1NCT03281551
Efficacy and Safety of PZ01 Treatment in Patients With r/r CD19+ B-cell Acute Lymphoblastic Leukemia/B Cell Lymphoma
A Phase 1 study testing PZ01 CAR-T cells in people with B-cell Acute Lymphoblastic Leukemia and B-cell Lymphoma, run by Pinze Lifetechnology Co. Ltd. at 1 site in China.
Trial summary
The major aim of this research is to assess the feasibility, safety and effectiveness of CD19 CAR-T Cell Therapy for Relapsed/ Refractory Acute Lymphoblastic Leukemia/ B cell Lymphoma patients who have applied it. Read more about this study
- Who is it for?
- Ages 14 to 65 years
- Conditions the study is for
- B-cell Acute Lymphoblastic Leukemia, B-cell Lymphoma
- What is being tested?
- PZ01 CAR-T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2017to 1 Nov 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 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects or their legal guardians participate in this experiment voluntarily and informed consent form must be signed
- In accordance with National Comprehensive Cancer Network (NCCN) ALL Guidelines for Patients (2016, v.1) and CD19+B-ALL/B cell lymphoma patients diagnosed by histology
- In accordance with r/r CD19+ B-ALL/B cell lymphoma diagnosis, including any of the following situations:
- Getting through 2 treatments of standard chemotherapy with CR not yet obtained
- Reach CR for the first inducement, but CR lasts for ≦12 months
- r/r CD19+ B-ALL/B cell lymphoma for no positive effect after first or repeated remedial treatment
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- ≧2 times of recurrence
- Remedial chemotherapy is not used within 4 weeks before cell therapy
- Immunosuppressive drug is not used within 4 weeks before cell therapy, including but not limited to systemic hormone therapy
- Antibody drug treatment is not received within 2 weeks before cell therapy
- Normal cardiac motion shown by echocardiography, left ventricular ejection fraction (LVEF) ≥50%, with no pericardial effusion and severe symptoms of cardiac arrhythmia
- No pulmonary active infection is found, with normal pulmonary function and indoor air SaO2 ≧92%
- No contraindications for leukapheresis
- Expected survival >3 months
- Grade 0 or 1 of ECOG performance status
Who cannot join
- Pregnant and breastfeeding women
- Uncontrolled active infection
- Uncontrolled infectious disease is diagnosed, such as HIV, syphilis, hepatitis A, hepatitis B, hepatitis C and E.
- Patients who have used a large amount of glucocorticoid or other immunosuppressive drugs within 4 weeks
- Stage II-IV Acute/chronic general graft versus host disease
- Gene therapy has been undergone in the past
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Hematology, Navy General Hospital of PLA
Beijing, Beijing Municipality, 100048
Lixin Wang, 86-013718000488, wgy@pinzelife.com
Jianliang Shen
About this study
Official title: Study of Anti-CD19 Chimeric Antigen Receptor T Cells（PZ01） for Relapsed/ Refractory B-cell Acute Lymphoblastic Leukemia/B Cell Lymphoma
The major aim of this research is to assess the feasibility, safety and effectiveness of CD19 CAR-T Cell Therapy for Relapsed/ Refractory Acute Lymphoblastic Leukemia/ B cell Lymphoma patients who have applied it.
- Being tested
- PZ01 CAR-T cells
- Medical subject headings
- Burkitt Lymphoma, Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PZ01 CAR-T cellsDrug
Chimeric antigen receptor (CAR) T cells targeting CD19 will be evaluated for safety and efficacy in patients with relapsed/ refractory B-cell Acute Lymphoblastic Leukemia/B cell Lymphoma. The CAR consists of a CD19 targeting antibody scFv with two intracellular signaling domains derived from CD3 zeta and 4-1BB. Autologous T cells will be gene-engineered with the CAR gene using a lentivirus vector. Prior to T cell infusion, the patients will be subjected to preconditioning treatment. After T cell infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of CAR T cells and efficacy.
| Study group | Role | What they receive |
|---|---|---|
| PZ01 CAR-T Cells | Experimental | This is a phase I study. Patients with relapsed/ refractory B-cell Acute Lymphoblastic Leukemia/B cell Lymphoma are eligible for enrollment. Receives: Drug: PZ01 CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment Related Adverse Events
To evaluate the safety of adoptive transfer of gene-modified autologous CD19-specific T cells in relapsed/ refractory B-cell Acute Lymphoblastic Leukemia/B cell Lymphoma.
Measured: 1 year
Secondary outcomes (3)
Overall response rate (ORR)
Proportion of patients with reduction in tumor burden.
Measured: 2 months
Overall survival (OS)
Time from study enrollment until death.
Measured: 6 months
Minimal residual disease negative remission rate(MRD)
Proportion of MRD-negative patients.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start1 Oct 2017 (estimated)
- Primary completion1 Sep 2020 (estimated)
- Study completion1 Nov 2020 (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 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pinze Lifetechnology Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chinese Academy of Sciences, Navy General Hospital, Beijing
- Responsible party
- Sponsor
- Investigators
- Shengdian Wang, Principal investigator, Insitute of Biophysics,Chinese Academy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03281551
- Sponsor's protocol ID
- PZ01
- Status last verified
- Sep 2017
- First submitted
- 9 Sep 2017
- Last updated
- 15 Sep 2017
- Results posted
- No
- 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 15 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Anti-CD19 Chimeric Antigen Receptor T Cells（PZ01） for Relapsed/ Refractory B-cell Acute Lymphoblastic Leukemia/B Cell Lymphoma
- ClinicalTrials.gov ID
- NCT03281551
- Acronym / sponsor ID
- PZ01
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Pinze Lifetechnology Co. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Chinese Academy of Sciences, Navy General Hospital, Beijing
- Study start
- 1 Oct 2017 (estimated)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 1 Nov 2020 (estimated)
- First posted
- 13 Sep 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 major aim of this research is to assess the feasibility, safety and effectiveness of CD19 CAR-T Cell Therapy for Relapsed/ Refractory Acute Lymphoblastic Leukemia/ B cell Lymphoma patients who have applied it.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PZ01 CAR-T Cells | Experimental | Drug: PZ01 CAR-T cellsThis is a phase I study. Patients with relapsed/ refractory B-cell Acute Lymphoblastic Leukemia/B cell Lymphoma are eligible for enrollment. |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- Subjects or their legal guardians participate in this experiment voluntarily and informed consent form must be signed
- In accordance with National Comprehensive Cancer Network (NCCN) ALL Guidelines for Patients (2016, v.1) and CD19+B-ALL/B cell lymphoma patients diagnosed by histology
- In accordance with r/r CD19+ B-ALL/B cell lymphoma diagnosis, including any of the following situations:
- Remedial chemotherapy is not used within 4 weeks before cell therapy
- Immunosuppressive drug is not used within 4 weeks before cell therapy, including but not limited to systemic hormone therapy
Key exclusion criteria (6 listed)
- Pregnant and breastfeeding women
- Uncontrolled active infection
- Uncontrolled infectious disease is diagnosed, such as HIV, syphilis, hepatitis A, hepatitis B, hepatitis C and E.
- Patients who have used a large amount of glucocorticoid or other immunosuppressive drugs within 4 weeks
- Stage II-IV Acute/chronic general graft versus host disease
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 |
|---|---|---|
| PZ01 CAR-T cellsChimeric antigen receptor (CAR) T cells targeting CD19 will be evaluated for safety and efficacy in patients with relapsed/ refractory B-cell Acute Lymphoblastic Leukemia/B cell Lymphoma. The CAR consists of a CD19 targeting antibody scFv with two intracellular signaling domains derived from CD3 zeta and 4-1BB. Autologous T cells will be gene-engineered with the CAR gene using a lentivirus vector. Prior to T cell infusion, the patients will be subjected to preconditioning treatment. After T cell infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of CAR T cells and efficacy. | Drug | PZ01 CAR-T Cells |
Primary outcome
Incidence of Treatment Related Adverse Events
Time frame: 1 year
To evaluate the safety of adoptive transfer of gene-modified autologous CD19-specific T cells in relapsed/ refractory B-cell Acute Lymphoblastic Leukemia/B cell Lymphoma.
3 secondary outcomes
Overall response rate (ORR)
Time frame: 2 months
Overall survival (OS)
Time frame: 6 months
Minimal residual disease negative remission rate(MRD)
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2017.
- 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.
Shengdian Wang principal investigator
Insitute of Biophysics,Chinese Academy of Sciences
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 PZ01 CAR-T cells in people with B-cell Acute Lymphoblastic Leukemia and B-cell Lymphoma, run by Pinze Lifetechnology 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 15 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 15 Sep 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guoyan Wang (+86-018661838188, 648818685@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment Related Adverse Events (time frame: 1 year). 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 15 Sep 2017.