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

NCT04204161 | Unknown Phase 1 DMC

• 1 other identifier: 2019XY-BDB011
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Relapsed B-cell Acute Lymphoblastic Leukemia, Childhood; Refractory B-cell Acute Lymphoblastic Leukemia, Childhood; Relapsed/Refractory B-cell Lymphoma, Childhood

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events evaluated with NCI CTC AE, version 4.0

  Safety evaluation

  60 months

Secondary Outcomes (2)

• Overall remission rate

  60 months

• CAR-T cells testing

  60 months

Study Arms (1)

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.

Biological: CAR-T19/CAR-T22

Interventions

CAR-T19/CAR-T22 BIOLOGICAL

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 .

CAR-T19/CAR-T22

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Shenzhen BinDeBio Ltd.: lead
• Xiangya Hospital of Central South University: collaborator

Study Sites (1)

Xiangya Hospital Central South University

Changsha, Hunan, 410008, China

RECRUITING

MeSH Terms

Conditions

Burkitt Lymphoma; Recurrence; Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yang Zhonghua

  Shenzhen BinDeBio Tech Co.,Ltd

  STUDY DIRECTOR

Central Study Contacts

Yang Zhonghua

CONTACT

18938688105; zh.yang@bindebio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2019
• First Posted: December 18, 2019
• Study Start: October 8, 2019
• Primary Completion: October 30, 2021
• Study Completion: October 8, 2024
• Last Updated: February 4, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)