A Clinical Study of CAR-T Cells Treatment for Children With CD19+/CD22+ R/R ALL and Lymphoma

  • STATUS
    Recruiting
  • End date
    Oct 8, 2024
  • participants needed
    30
  • sponsor
    Shenzhen BinDeBio Ltd.
Updated on 21 February 2022

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.

Details
Condition Relapsed B-cell Acute Lymphoblastic Leukemia, Childhood, Refractory B-cell Acute Lymphoblastic Leukemia, Childhood, Relapsed/Refractory B-cell Lymphoma, Childhood
Treatment CAR-T19/CAR-T22
Clinical Study IdentifierNCT04204161
SponsorShenzhen BinDeBio Ltd.
Last Modified on21 February 2022

Eligibility

Yes No Not Sure

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>=5010^9/L
Liver function: ALT and AST2.5 (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

ECOG >= 3
Patients with history of T cell tumors
organ failure:heart failure and ;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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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