Safety and Efficacy of CD19 and CD22 Targeted CAR-T Therapy for Relapsed/Refractory B Cell Leukemia and Lymphoma

NCT04648475 | Unknown Phase 1

• 1 other identifier: PBC019
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single arm study to evaluate the efficacy and safety of CD19 and CD22 targeted CAR-T cells therapy for patients with relapsed/refractory B Cell Leukemia and Lymphoma.

Conditions

Leukemia, B-cell; Lymphoma, B-Cell

Keywords

CAR-T; CD19; CD22

Outcome Measures

Primary Outcomes (2)

• Adverse events that related to treatment

  Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).

  2 years

• The response rate of CD19 and CD22 CAR-T treatment in patients with relapse/refractory B Cell Leukemia and Lymphoma

  The response rate of CD19 and CD22 CAR-T treatment will be recorded and assessed according to the National Comprehensive Cancer Network Guideline.

  6 months

Secondary Outcomes (10)

• Rate of CD19 and CD22 CAR-T cells in bone marrow and peripheral blood

  2 years

• Quantity of CD19 and CD22 CAR copies in bone marrow and peripheral blood

  2 years

• Cellular kinetics of CD19 and CD22 positive cells in Bone marrow

  1 years

• Levels of IL-6 in Serum

  3 months

• Levels of IL-10 in Serum

  3 months

Study Arms (1)

Arm 1

EXPERIMENTAL

CD19 and CD22 targeted CAR-T cells treat

Biological: CD19 and CD22 targeted CAR-T cells

Interventions

CD19 and CD22 targeted CAR-T cells BIOLOGICAL

A single infusion of CD19 and CD22 CAR-T cells will be administered intravenously

Arm 1

Eligibility Criteria

• Age: 3 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent;
• Diagnose as relapsed /refractory B Cell Leukemia and Lymphoma, and meet one of the following conditions:
• Failed to standard chemotherapy regimens;
• Relapse after complete remission, high-risk and / or refractory patients ;
• Relapse after hematopoietic stem cell transplantation;
• For patients with Ph + ALL, the following conditions must be met: those who have received a standard induction chemotherapy regimen and who have not achieved complete remission after TKI treatment or have relapsed after remission (cannot tolerate TKI treatment or have contraindications to TKI treatment or the presence of TKI class) Except for drug resistant patients)；
• Evidence for cell membrane CD19 and CD22 expression;
• All genders, ages: 3 to 75 years；
• The expect time of survive is above 12 weeks;
• KPS\>60；
• No serious mental disorders ;
• Left ventricular ejection fraction ≥50%
• Sufficient hepatic function defined by ALT/AST≤3 x ULN and bilirubin≤2 x ULN;
• Sufficient renal function defined by creatinine clearance≤2 x ULN;
• Sufficient pulmonary function defined by indoor oxygen saturation≥92%;

You may not qualify if:

• Have received CAR-T therapy or other genetically modified cell therapy before screening；
• Participated in other clinical research within 1 month before screening；
• Have received the following anti-tumor treatment before screening: Have received chemotherapy, targeted therapy or other experimental drug treatment within 4 weeks, except those who have confirmed disease progression after treatment;
• Live attenuated vaccine within 4 weeks before screening;
• Convulsion or stoke within past 6 months;
• Previous history of other malignancy;
• Presence of uncontrolled active infection;
• Subjects with positive HBsAg or HBcAb positive and peripheral blood HBV DNA titer is higher than the lower limit of detection of the research institution; HCV antibody positive and peripheral blood HCV RNA titer is higher than the lower limit of detection of the research institution; HIV antibody positive; syphilis primary screening antibody positive;
• Pregnant or breasting-feeding women;
• Any situation that investigators regard not suitable for attending in this study or may affect the data analysis.

Sponsors & Collaborators

• Chongqing Precision Biotech Co., Ltd: lead

Study Sites (1)

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

RECRUITING

MeSH Terms

Conditions

Leukemia, B-Cell; Lymphoma, B-Cell

Interventions

Antigens, CD19

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin; Lymphoma

Intervention Hierarchy (Ancestors)

Antigens, CD; Antigens, Differentiation; Antigens, Surface; Antigens; Biological Factors; Antigens, Differentiation, B-Lymphocyte; Minor Histocompatibility Antigens; Histocompatibility Antigens; Isoantigens; Biomarkers

Study Officials

• Cheng Qian, PhD

  Chongqing University Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhi Yang, PhD

CONTACT

86-13206140093; yangzhi@precision-biotech.com

Yingzi Zhang

CONTACT

86-18623351275; yingzi6526@163.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: August 30, 2020
• First Posted: December 1, 2020
• Study Start: August 25, 2020
• Primary Completion: December 31, 2023
• Study Completion: July 1, 2024
• Last Updated: April 18, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)