NCT04204161RecruitingPhase 1
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
Shenzhen BinDeBio Ltd.1 site in 1 country30 target enrollmentStarted: October 8, 2019Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Number of Participants With Adverse Events evaluated with NCI CTC AE, version 4.0
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 1 Month to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
- •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
Exclusion Criteria
- •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.
- •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.
Outcomes
Primary Outcomes
Number of Participants With Adverse Events evaluated with NCI CTC AE, version 4.0
Time Frame: 60 months
Safety evaluation
Secondary Outcomes
- Overall remission rate(60 months)
- CAR-T cells testing(60 months)
Investigators
Study Sites (1)
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