Clinical trial NCT04204161: A Clinical Study of CAR-T Cells Treatment for Children With CD19+/CD22+ R/R ALL and Lymphoma
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Relapsed B-cell Acute Lymphoblastic Leukemia, Childhood
Refractory B-cell Acute Lymphoblastic Leukemia, Childhood
Relapsed/Refractory B-cell Lymphoma, Childhood
Lead sponsor: Shenzhen BinDeBio Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Xiangya Hospital of Central South University
First posted: 2019-12-18
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

  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:

1. ECOG \>= 3.
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.

Primary outcomes:
measure: Number of Participants With Adverse Events evaluated with NCI CTC AE, version 4.0
timeFrame: 60 months
Secondary outcomes:
measure: Overall remission rate
timeFrame: 60 months
measure: CAR-T cells testing
timeFrame: 60 months
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
Study officials:
affiliation: Shenzhen BinDeBio Tech Co.,Ltd
name: Yang Zhonghua
role: STUDY_DIRECTOR
References: