CD19+Targeted CAR-T Cell Therapy for Relapsed/Refractory CD19+ B Cell Leukemia and Lymphoma

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

Study Overview

• Status: Recruiting
• Conditions: Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Leukemia; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, B-cell
• Intervention / Treatment: Biological: CD19 CAR-T cells

Detailed Description

There are limited options for treatment of relapse/refractory B Cell Leukemia and Lymphoma.CD19 is expressed on most B Cell Leukemia and Lymphoma cells so it is an ideal target for CAR-T. In this study, investigators will evaluate the safety and efficacy of CAR-T targeting CD19 in patients with elapsed/refractory CD19+ B Cell Leukemia and Lymphoma. The primary goal is safety and efficiency assessment, including adverse events and disease status after treatment.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Yunnan
    • Kunming, Yunnan, China
      • Recruiting
      • 920th Hospital of Joint Logistics Support Force

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Signed written informed consent；

2. Diagnose as relapsed/refractory B Cell Leukemia and Lymphoma, and meet one of the following conditions:

   1. Failed to standard chemotherapy regimens;
   2. Relapse after complete remission, high-risk and / or refractory patients ;
   3. Relapse after hematopoietic stem cell transplantation;
3. 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)；
4. Evidence for cell membrane CD19 expression；
5. All genders ，ages: 2 to 75 years；
6. The expect time of survive is above 3 months;
7. KPS>60；
8. No serious mental disorders ;
9. Left ventricular ejection fraction ≥50%
10. Sufficient hepatic function defined by ALT/AST≤3 x ULN and bilirubin≤2 x ULN;
11. Sufficient renal function defined by creatinine clearance≤2 x ULN;
12. Sufficient pulmonary function defined by indoor oxygen saturation≥92%;
13. With single or venous blood collection standards, and no other cell collection contraindications;
14. Ability and willingness to adhere to the study visit schedule and all protocol requirements.

Exclusion Criteria:

1. Previous history of other malignancy;
2. Presence of uncontrolled active infection;
3. Evidence of disorder that need the treatment by glucocorticoids;
4. Active or chronic GVHD；
5. The patients treatment by inhibitor of T cell；
6. Pregnant or breasting-feeding women;
7. Any situation that investigators regard not suitable for attending in this study (e.g. HIV , HCVinfection or intravenous drug addiction) or may affect the data analysis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CD19 CAR-T cells treat; Patients will be be treated with CD19 CAR-T cells	Biological: CD19 CAR-T cells; CD19 CAR-T cell therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 CAR-T treatment in patients with relapse/refractory B Cell Leukemia and Lymphoma that treatment by CD19 CAR-T cells therapy	The response rate of CD19 CAR-T treatment will be recorded and assessed according to the National Comprehensive Cancer Network Guideline	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of CD19 CAR-T cells in bone marrow and peripheral blood	In vivo (bone marrow and peripheral blood) rate of CD19 CAR-T cells were determined by means of flow cytometry	2 years
Quantity of CD19 CAR copies in bone marrow and peripheral blood	In vivo (bone marrow and peripheral blood) quantity of CD19 CAR copies were determined by means of qPCR	2 years
Cellular kinetics of CD19 positive cells in bone marrow	In vivo (bone marrow) rate and quantity of CD19 positive cells were determined by means of flow cytometry	1 years
Duration of Response (DOR) of CD19 CAR-T treatment in patients with refractory/relapsed B Cell Leukemia and Lymphoma	DOR will be assessed from the first assessment of CR or CRi to the first assessment of recurrence or progression of the disease or death from any cause (censored)	2 years
Progress-free survival(PFS) of CD19 CAR-T treatment in patients with refractory/relapsed B Cell Leukemia and Lymphoma	PFS will be assessed from the first CAR-T cell infusion to death from any cause or the first assessment of progression (censored)	2 years
Overall survival(OS) of CD19 CAR-T treatment in patients with refractory/relapsed B Cell Leukemia and Lymphoma	OS will be assessed from the first CAR-T cell infusion to death from any cause (censored)	2 years

Collaborators and Investigators

• Sponsor: Chongqing Precision Biotech Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): July 1, 2024

Study Registration Dates

• First Submitted: February 13, 2020
• First Submitted That Met QC Criteria: February 14, 2020
• First Posted (Actual): February 17, 2020

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 16, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Lymphoma; Leukemia
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Leukemia; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Lymphoid; Leukemia, B-Cell
• Other Study ID Numbers: PBC004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No