A Clinical Study of CAR-T Cells Treatment for Children With CD19+/CD22+ R/R ALL and Lymphoma
NCT ID: NCT04204161
Last Updated: 2021-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE1
30 participants
INTERVENTIONAL
2019-10-08
2024-10-08
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Phase II Study of Anti-CD19 CAR-T Cells Treating Leukemia Children
NCT04325841
Safety and Efficacy of Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy in R/R Acute B Lymphoblastic Leukemia
NCT04094766
A Study of pCAR-19B in the Treatment of CD19-positive Relapsed/Refractory B-ALL in Children and Adolescents
NCT05334823
CD19 hsCAR-T for Refractory/Relapsed CD19+ B-ALL Patients
NCT03902197
Anti-CD19 CAR-T Cells for Relapsed or Refractory Acute Lymphoblastic Leukemia and Lymphomas
NCT04196205
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CAR-T19/CAR-T22
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.
CAR-T19/CAR-T22
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 .
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CAR-T19/CAR-T22
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 .
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. no available curative treatment options (such as autologous or allogeneic SCT)
2. If patients had receive immunotherapy, they should reach requirments:tumor recurrency or the number of B cells recovered.
3. 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;
4. Patients must be willing to sign an informed consent.
5. Age:≤18 years.
6. survival\>12 weeks
7. Flow cytometry or IHC showed positive expression of CD19/ CD22 in tumor cells within two months.
8. Routine blood test:hemoglobin\>=90 g/L; platelet\>=50×10\^9/L.
9. 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.
10. Renal function:BUN: 9-20mg / dl; serum creatinine\<= 1.5 times upper limits of normal; endogenous creatinine clearance rate\>=50 ml/min
11. Negative serum antibody for EBV, CMV, HIV , syphilis, HBVa nd HCV.
12. Cardiac function: stable hemodynamic and left ventricular ejection fraction (LVEF)\>=55%.
13. ECOG score ≤2。
14. Adequate venous access for apheresis, and no other contraindications for leukapheresis
Exclusion Criteria
2. Patients with history of T cell tumors .
3. 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.
4. Acute or chronic GVHD after allogeneic hematopoiesis. Hormone or immunosuppressant was used within 30 days.
5. steroid hormoneswere used before and after blood collection and infusion.
6. HIV infection or active hepatitis B or hepatitis C infection.
7. Uncontrolled active infection.
8. Enrolled to other clinical study in the last 4 weeks.
9. Subjects with systemic auto-immune disease or immunodeficiency.
10. Allergic to cytokines.
11. 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.
12. Patients with malignant tumors of the central nervous system.
13. Lung, brain or intestinal tumor infiltrates.
14. The second tumor was found.
15. Allergic to cytokine antagonists.
16. Other patients that researchers considered unsuitable for inclusion.
1 Month
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Xiangya Hospital of Central South University
OTHER
Shenzhen BinDeBio Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Yang Zhonghua
Role: STUDY_DIRECTOR
Shenzhen BinDeBio Tech Co.,Ltd
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Xiangya Hospital Central South University
Changsha, Hunan, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Yang Minghua, PhD
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2019XY-BDB011
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.