Relapsed B-cell Acute Lymphoblastic Leukemia, ChildhoodPhase 1NCT04204161
A Clinical Study of CAR-T Cells Treatment for Children With CD19+/CD22+ R/R ALL and Lymphoma
A Phase 1 study testing CAR-T19/CAR-T22 in people with Relapsed B-cell Acute Lymphoblastic Leukemia, Childhood and Refractory B-cell Acute Lymphoblastic Leukemia, Childhood, run by Shenzhen BinDeBio Ltd. at 1 site in China.
Trial summary
This is a single arm, open-label, uni-center, phase I study . In this study, Children withCD19+/CD22+ R/R B-cell acute lymphoblastic leukemia or lymphoma will be treated with CAR-T19/CAR-T22 Immunotherapy to determine the safety and efficacy of treatment. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Relapsed B-cell Acute Lymphoblastic Leukemia, Childhood, Refractory B-cell Acute Lymphoblastic Leukemia, Childhood, Relapsed/Refractory B-cell Lymphoma, Childhood
- What is being tested?
- CAR-T19/CAR-T22
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 8 Oct 2019to 8 Oct 2024
- 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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male and female subjects with CD19+/CD22+ B cell malignancies who have limited prognosis (several months to < 2 year survival) with currently available therapies will be enrolled.
- no available curative treatment options (such as autologous or allogeneic SCT)
- If patients had receive immunotherapy, they should reach requirments:tumor recurrency or the number of B cells recovered.
- Patients with recurrence after hematopoietic stem cell transplantation need additional satisfaction: 1) no GvHD and not require immunosuppression;2) stem cell transplantation was completed for at least 4 months, and at least 6 months before the CART reinfusion;
- Patients must be willing to sign an informed consent.
- Age:≤18 years.
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- survival>12 weeks
- Flow cytometry or IHC showed positive expression of CD19/ CD22 in tumor cells within two months.
- Routine blood test:hemoglobin>=90 g/L; platelet>=50×10^9/L.
- Liver function: ALT and AST≤2.5 (ULN) times the upper limits of normal (if abnormal liver function is mainly caused by tumor infiltration, it can ≤5 ULN), bilirubin <2.0 mg/dl.
- Renal function:BUN: 9-20mg / dl; serum creatinine<= 1.5 times upper limits of normal; endogenous creatinine clearance rate>=50 ml/min
- Negative serum antibody for EBV, CMV, HIV , syphilis, HBVa nd HCV.
- Cardiac function: stable hemodynamic and left ventricular ejection fraction (LVEF)>=55%.
- ECOG score ≤2。
- Adequate venous access for apheresis, and no other contraindications for leukapheresis
Who cannot join
- ECOG >= 3.
- Patients with history of T cell tumors .
- organ failure:heart failure Ⅲ and Ⅳ;The liver reached grade C of child-turcotte .Renal failure and uremia;Respiratory failure;People with impaired consciousness.
- Acute or chronic GVHD after allogeneic hematopoiesis. Hormone or immunosuppressant was used within 30 days.
- steroid hormoneswere used before and after blood collection and infusion.
- HIV infection or active hepatitis B or hepatitis C infection.
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- Uncontrolled active infection.
- Enrolled to other clinical study in the last 4 weeks.
- Subjects with systemic auto-immune disease or immunodeficiency.
- Allergic to cytokines.
- Definite neuropathic or psychotic patients, including authors of dementia or seizures, history of psychotropic substance abuse and unable to quit, or other substantial lesions that may increase central neurotoxicity.
- Patients with malignant tumors of the central nervous system.
- Lung, brain or intestinal tumor infiltrates.
- The second tumor was found.
- Allergic to cytokine antagonists.
- Other patients that researchers considered unsuitable for inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xiangya Hospital Central South University
Changsha, Hunan, 410008
Yang Minghua, PhD, 13973135843
About this study
Official title: A Clinical Study Evaluating the Safety and Efficacy of CAR-T19/CAR-T22 Treatment for Children With CD19 Positive Relapse or Refractory Childhood Acute Lymphoblastic Leukemia and Lymphoma
This is a single arm, open-label, uni-center, phase I study . In this study, Children withCD19+/CD22+ R/R B-cell acute lymphoblastic leukemia or lymphoma will be treated with CAR-T19/CAR-T22 Immunotherapy to determine the safety and efficacy of treatment.
- Conditions
- Relapsed B-cell Acute Lymphoblastic Leukemia, Childhood, Refractory B-cell Acute Lymphoblastic Leukemia, Childhood, Relapsed/Refractory B-cell Lymphoma, Childhood
- Being tested
- CAR-T19/CAR-T22
- Medical subject headings
- Burkitt Lymphoma, Recurrence, Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR-T19/CAR-T22Biological
According to tumor burden and other conditions, patients will be treated with cyclophosphamide or fludarabine,then,CAR-T cells will be infused 48-72 hours later.The recommand dose is 1x10^5/kg-2.5x10^8/kg .
| Study group | Role | What they receive |
|---|---|---|
| CAR-T19/CAR-T22 | Experimental | CAR-T19/CAR-T22 (autologous T cells transduced with CD19 / 22 CAR-ζ/4-1BB vector) will be administered to children with R/R B cell Acute Lymphoblastic Leukemia (ALL) or Lymphoma as an IV infusion on days 0, 1 and 2 in the absence of disease progression or unacceptable toxicity. Receives: Biological: CAR-T19/CAR-T22 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events evaluated with NCI CTC AE, version 4.0
Safety evaluation
Measured: 60 months
Secondary outcomes (2)
Overall remission rate
Overall remission rate consists of complete remission rate and partial remission rate of patients being treated with CAR-T19/CAR-T22
Measured: 60 months
CAR-T cells testing
The level of CAR-T cells will be tested regularly by Real-time Quantitative Polymerase Chain Reaction Detecting System(qPCR) or Flow cytometry to evaluate the proliferation in vivo and long-term survival.
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start8 Oct 2019
- Primary completion30 Oct 2021 (estimated)
- Study completion8 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed B-cell Acute Lymphoblastic Leukemia, ChildhoodStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen BinDeBio Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Xiangya Hospital of Central South University
- Responsible party
- Sponsor
- Investigators
- Yang Zhonghua, Study director, Shenzhen BinDeBio Tech Co.,Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04204161
- Sponsor's protocol ID
- 2019XY-BDB011
- Status last verified
- Feb 2021
- First submitted
- 13 Dec 2019
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 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 CAR-T19/CAR-T22 Treatment for Children With CD19 Positive Relapse or Refractory Childhood Acute Lymphoblastic Leukemia and Lymphoma
- ClinicalTrials.gov ID
- NCT04204161
- Acronym / sponsor ID
- 2019XY-BDB011
- Conditions
- Relapsed B-cell Acute Lymphoblastic Leukemia, Childhood, Refractory B-cell Acute Lymphoblastic Leukemia, Childhood, Relapsed/Refractory B-cell Lymphoma, Childhood
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shenzhen BinDeBio Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Xiangya Hospital of Central South University
- Study start
- 8 Oct 2019 (actual)
- Primary completion
- 30 Oct 2021 (estimated)
- Study completion
- 8 Oct 2024 (estimated)
- First posted
- 18 Dec 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, uni-center, phase I study . In this study, Children withCD19+/CD22+ R/R B-cell acute lymphoblastic leukemia or lymphoma will be treated with CAR-T19/CAR-T22 Immunotherapy to determine the safety and efficacy of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAR-T19/CAR-T22 | Experimental | Biological: CAR-T19/CAR-T22CAR-T19/CAR-T22 (autologous T cells transduced with CD19 / 22 CAR-ζ/4-1BB vector) will be administered to children with R/R B cell Acute Lymphoblastic Leukemia (ALL) or Lymphoma as an IV infusion on days 0, 1 and 2 in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (15 listed)
- Male and female subjects with CD19+/CD22+ B cell malignancies who have limited prognosis (several months to < 2 year survival) with currently available therapies will be enrolled.
Key exclusion criteria (16 listed)
- ECOG >= 3.
- Patients with history of T cell tumors .
- organ failure:heart failure Ⅲ and Ⅳ;The liver reached grade C of child-turcotte .Renal failure and uremia;Respiratory failure;People with impaired consciousness.
- Acute or chronic GVHD after allogeneic hematopoiesis. Hormone or immunosuppressant was used within 30 days.
- steroid hormoneswere used before and after blood collection and infusion.
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 |
|---|---|---|
| CAR-T19/CAR-T22According to tumor burden and other conditions, patients will be treated with cyclophosphamide or fludarabine,then,CAR-T cells will be infused 48-72 hours later.The recommand dose is 1x10^5/kg-2.5x10^8/kg . | Biological | CAR-T19/CAR-T22 |
Primary outcome
Number of Participants With Adverse Events evaluated with NCI CTC AE, version 4.0
Time frame: 60 months
Safety evaluation
2 secondary outcomes
Overall remission rate
Time frame: 60 months
CAR-T cells testing
Time frame: 60 months
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.
- 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.
Yang Zhonghua study director
Shenzhen BinDeBio Tech Co.,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 study testing CAR-T19/CAR-T22 in people with Relapsed B-cell Acute Lymphoblastic Leukemia, Childhood and Refractory B-cell Acute Lymphoblastic Leukemia, Childhood, 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 15 inclusion and 16 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 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 Yang Zhonghua (18938688105, zh.yang@bindebio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events evaluated with NCI CTC AE, version 4.0 (time frame: 60 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 4 Feb 2021; AzTrials last refreshed its copy on 8 Nov 2026.