Relapsed B-cell Acute Lymphoblastic LeukemiaPhase 1/2NCT03156101
A Clinical Study Evaluating the Safety and Efficacy of BinD19 Treatment in R/R ALL and Lymphoma Subjects
A Phase 1/2 study testing BinD19 in people with Relapsed B-cell Acute Lymphoblastic Leukemia and Refractory B-cell Acute Lymphoblastic Leukemia, run by Shenzhen BinDeBio Ltd. at 1 site in China.
Trial summary
This is a single arm, open-label, uni-center, phase I/II study to determine the safety and efficacy of an experimental therapy called BinD19 cells in patients with B-cell acute lymphoblastic leukemia or lymphoma, who are chemo-refractory, relapsed after allogeneic SCT, or are otherwise ineligible for allogeneic stem… Read more about this study
- Who is it for?
- Ages 4 to 70 years
- Conditions the study is for
- Relapsed B-cell Acute Lymphoblastic Leukemia, Refractory B-cell Acute Lymphoblastic Leukemia, Relapsed／Refractory B-cell Lymphoma
- What is being tested?
- BinD19
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 2 Mar 2017to 30 Dec 2021
- 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 4 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male and female subjects with CD19+ B cell malignancies in patients with no available curative treatment options (such as autologous or allogeneic SCT) who have limited prognosis (several months to < 2 year survival) with currently available therapies will be enrolled.
- CD19+ leukemia or lymphoma
- Not eligible for allogeneic SCT because of age, comorbid disease, or lack of available family member or unrelated donor
- Follicular lymphoma, previously identified as CD19+:
- Disease responding or stable after most recent therapy (chemotherapy, MoAb, etc)
- ECOG result is 0, 1 or 2.
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- With normal heart, liver and kidney functions.
- Negative serum antibody for EBV, CMV, HBV, HCV, HIV and syphilis.
- Negative in pregnancy test （female subject only).
Who cannot join
- ECOG result is 3, 4 or 5.
- Pregnant or lactating women
- Uncontrolled active infection
- Active hepatitis B or hepatitis C infection
- Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary
- Previously treatment with any gene therapy products
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- HIV infection
- Enrolled to other clinical study in the last 4 weeks.
- Subjects with systemic auto-immune disease or immunodeficiency.
- Subjects with CNS diseases.
- Subjects with secondary tumors.
- Subjects with tumor infiltration in liver, brain or GI tract.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
About this study
Official title: A Clinical Study Evaluating the Safety and Efficacy of BinD19 Treatment in Relapse or Refractory Acute Lymphoblastic Leukemia and Lymphoma Subjects
This is a single arm, open-label, uni-center, phase I/II study to determine the safety and efficacy of an experimental therapy called BinD19 cells in patients with B-cell acute lymphoblastic leukemia or lymphoma, who are chemo-refractory, relapsed after allogeneic SCT, or are otherwise ineligible for allogeneic stem cell transplant.
- Conditions
- Relapsed B-cell Acute Lymphoblastic Leukemia, Refractory B-cell Acute Lymphoblastic Leukemia, Relapsed／Refractory B-cell Lymphoma
- Being tested
- BinD19
- Medical subject headings
- Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BinD19Biological
Autologous T cells purified from the peripheral blood mononuclear cells of subjects, transduced with TCR-ζ/4-1BB lentiviral vector, expanded in vitro and then frozen for future administration.
| Study group | Role | What they receive |
|---|---|---|
| BinD19 | Experimental | BinD19 (autologous T cells transduced with CD19 TCR-ζ/4-1BB vector) administered as an IV infusion on days 0, 1 and 2 in the absence of disease progression or unacceptable toxicity. Minimum/maximum dose: 1x10^6/kg / 1x10^7/kg administered to patients with R/R B cell Acute Lymphoblastic Leukemia (ALL) or Lymphoma. Receives: Biological: BinD19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events [Safety and Feasibility]
Occurrence of study related adverse events defined as NCI CTCAE 4.0 > grade 3 possibly, probably, or definitely related to study treatment.
Measured: Study treatment until Week 24
Secondary outcomes (1)
Overall Response [Efficacy]
Efficacy assessments for ALL were performed based on bone marrow and blood morphologic criteria and physical examination findings. Efficacy assessments for Lymphoma were based on tumor load, B cell number and immunoglobulins.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start2 Mar 2017
- Primary completion30 May 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Relapsed 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen BinDeBio Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- QIU SHI Zhuang, PhD, Study director, Shenzhen BinDeBio Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03156101
- Sponsor's protocol ID
- 2017ZDYFY-BinD19
- Status last verified
- Feb 2021
- First submitted
- 15 May 2017
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen X, Li X, Liu Y, Zhang Z, Zhang X, Huang J, Li H, Li F, Zhang L, Li L, Wu X, Ma W, Sun Z, Yu H, Zhou Z, Feng X, Cui K, Li Z, Zhang H, Zeng Y, Wan X, Chen YH, Zhang M, Zhang Y. A Phase I clinical trial of chimeric antigen receptor-modified T cells in patients with relapsed and refractory lymphoma. Immunotherapy. 2020 Jul;12(10):681-696. doi: 10.2217/imt-2020-0022. Epub 2020 Jun 25.
PubMed 32580597
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study Evaluating the Safety and Efficacy of BinD19 Treatment in Relapse or Refractory Acute Lymphoblastic Leukemia and Lymphoma Subjects
- ClinicalTrials.gov ID
- NCT03156101
- Acronym / sponsor ID
- 2017ZDYFY-BinD19
- Conditions
- Relapsed B-cell Acute Lymphoblastic Leukemia, Refractory B-cell Acute Lymphoblastic Leukemia, Relapsed／Refractory B-cell Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Shenzhen BinDeBio Ltd.Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Zhengzhou University
- Study start
- 2 Mar 2017 (actual)
- Primary completion
- 30 May 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 17 May 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.
This is a single arm, open-label, uni-center, phase I/II study to determine the safety and efficacy of an experimental therapy called BinD19 cells in patients with B-cell acute lymphoblastic leukemia or lymphoma, who are chemo-refractory, relapsed after allogeneic SCT, or are otherwise ineligible for allogeneic stem cell transplant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BinD19 | Experimental | Biological: BinD19BinD19 (autologous T cells transduced with CD19 TCR-ζ/4-1BB vector) administered as an IV infusion on days 0, 1 and 2 in the absence of disease progression or unacceptable toxicity. Minimum/maximum dose: 1x10^6/kg / 1x10^7/kg administered to patients with R/R B cell Acute Lymphoblastic Leukemia (ALL) or Lymphoma. |
Who may qualify
- Ages
- 4 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Male and female subjects with CD19+ B cell malignancies in patients with no available curative treatment options (such as autologous or allogeneic SCT) who have limited prognosis (several months to < 2 year survival) with currently available therapies will be enrolled.
- CD19+ leukemia or lymphoma
- Not eligible for allogeneic SCT because of age, comorbid disease, or lack of available family member or unrelated donor
- Follicular lymphoma, previously identified as CD19+:
- Disease responding or stable after most recent therapy (chemotherapy, MoAb, etc)
Key exclusion criteria (12 listed)
- ECOG result is 3, 4 or 5.
- Pregnant or lactating women
- Uncontrolled active infection
- Active hepatitis B or hepatitis C infection
- Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary
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 |
|---|---|---|
| BinD19Autologous T cells purified from the peripheral blood mononuclear cells of subjects, transduced with TCR-ζ/4-1BB lentiviral vector, expanded in vitro and then frozen for future administration. | Biological | BinD19 |
Primary outcome
Number of Participants With Adverse Events [Safety and Feasibility]
Time frame: Study treatment until Week 24
Occurrence of study related adverse events defined as NCI CTCAE 4.0 > grade 3 possibly, probably, or definitely related to study treatment.
1 secondary outcome
Overall Response [Efficacy]
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Derived from this study: PubMed 32580597Chen X, Li X, Liu Y, Zhang Z, Zhang X, Huang J, Li H, Li F, Zhang L, Li L, Wu X, Ma W, Sun Z, Yu H, Zhou Z, Feng X, Cui K, Li Z, Zhang H, Zeng Y, Wan X, Chen YH, Zhang M, Zhang Y. A Phase I clinical trial of chimeric antigen receptor-modified T cells in patients with relapsed and refractory lymphoma. Immunotherapy. 2020 Jul;12(10):681-696. doi: 10.2217/imt-2020-0022. Epub 2020 Jun 25.
- 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.
QIU SHI Zhuang, PhD study director
Shenzhen BinDeBio Ltd.
1 site 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 BinD19 in people with Relapsed B-cell Acute Lymphoblastic Leukemia and Refractory B-cell Acute Lymphoblastic Leukemia, run by Shenzhen BinDeBio 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 9 inclusion and 12 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 4 Feb 2021. 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 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?
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?
Number of Participants With Adverse Events [Safety and Feasibility] (time frame: Study treatment until Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03156101, which also lists 1 linked publication.
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 4 Feb 2021.