search
Back to results

A Study of Novel Anti-CD19 CAR-T in Patients With r/r B-Cell Malignancies

Primary Purpose

B-Cell Leukemia, B-Cell Lymphoma, B-cell Tumors

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Anti-CD19 Autologous CAR-T Cell Infusion
Sponsored by
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for B-Cell Leukemia focused on measuring B Cell, CAR-T, CD19, Leukemia, Lymphoma

Eligibility Criteria

2 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria: A definite diagnosis of relapsed/refractory B-cell malignancies; Male or female, aged 2-75 years; Confirmed detectable disease; Expected survival time >12 weeks; Eastern cooperative oncology group (ECOG) score is 0-2; Adequate liver , kidney and cardiopulmonary function; Women of childbearing age have negative blood pregnancy test before the start of the trial, and agree to take effective contraceptive measures during the trial until the last follow-up; male subjects with partners of childbearing potential agree to take effective contraceptive measures during the trial until the last follow-up; Willingness to complete the informed consent process and to comply with study procedures and visit schedule. Key Exclusion Criteria: Presence of other concurrent active malignancy; People with severe mental disorders; History of any of the following genetic disorders, such as Fanconi anemia, Schu-Day syndrome, Gerstmann syndrome, or any other known bone marrow failure syndrome; Acute GVHD of grade II-IV or extensive chronic GVHD; Grade III-IV heart failure or myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, or other clinically prominent heart disease within one year prior to enrollment; The presence of any indwelling catheter or drainage (e.g., percutaneous nephrostomy, indwelling catheter, bile drainage, or pleural/peritoneal/pericardial catheter), except for patients who are permitted to use dedicated central venous catheters; Human immunodeficiency virus (HIV) seropositivity; Hepatitis B surface antigen positive or hepatitis B core antibody positive, and HBV-DNA positive; Patients with hepatitis C (HCV-RNA quantitative test results positive); Or the presence of other serious active viral or bacterial infections or uncontrolled systemic fungal infections; Patients with severe history of allergy or allergic constitution; A history of autoimmune diseases (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) leading to end-organ damage or requiring systemic immunosuppressive/systemic disease modulating drugs within the past 2 years; Had or is suffering from interstitial lung disease (e.g., pneumonia, pulmonary fibrosis); Had undergone other clinical trials in the 4 weeks prior to participating in this trial; Poor compliance due to physiological, family, social, geographical and other factors, unable to cooperate with the study protocol and follow-up plan; For patients contraindicated with cyclophosphamide and fludarabine chemotherapy; Subjects requiring systemic corticosteroid therapy (prednisone ≥5mg/ day or equivalent dose of another corticosteroid) or other immunosuppressive agents within 1 month after UCAR-T cell reinfusion, except for adverse events; Receiving donor lymphocyte infusion within 6 weeks before enrollment; Pregnant and lactating women; Subjects with any other condition which the investigator considers unsuitable for inclusion in the study.

Sites / Locations

  • 920th Hospital of Joint Logistics Support Force of People's Liberation Army of ChinaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OlyCAR-019 Cell Infusion

Arm Description

OlyCAR-019 cell infusion will be administered by vein after short-time manufacture.

Outcomes

Primary Outcome Measures

Incidence of adverse events(AE) after infusion
The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included.
MTD
MTD will be determined based on DLTs observed during the first 28 days of study treatment.

Secondary Outcome Measures

Overall Response Rate (ORR)
Overall Response Rate (ORR) is defined as the proportion of subjects achieving complete remission(CR) and partial response(PR).
Progression-free survival(PFS)
Progression-free survival(PFS) refers to the time from cell infusion to the first assessment of tumor progression or death from any cause.

Full Information

First Posted
June 27, 2023
Last Updated
July 9, 2023
Sponsor
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
search

1. Study Identification

Unique Protocol Identification Number
NCT05932173
Brief Title
A Study of Novel Anti-CD19 CAR-T in Patients With r/r B-Cell Malignancies
Official Title
An Open Label, Single-site, Dose-escalation Study Aiming to Evaluate the Efficacy and Safety of Anti-CD19 CAR-T Manufactured by OlyCAR Platform(OlyCAR-019) in the Treatment of Relapsed/ Refractory(r/r) B-Cell Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
It is a single-center, open-labeled, single-arm, non-randomized, investigator-initiated trial aiming to evaluate the efficacy and safety of anti-CD19 CAR-T manufactured by OlyCAR platform (OlyCAR-019) for CD19+ refractory/relapsed B-Cell malignancies.
Detailed Description
OlyCAR is a novel CAR-T manufacturing system which allows to generate clinical-use CAR-T cells in short time. This study is going to evaluate the feasibility of CAR-T manufactured by OlyCAR platform in the treatment of B-Cell malignancies. The OlyCAR-019 cells will be infused by vein. Subjects will be followed for safety and efficacy up to 12 weeks. For those with a durable remission 12 weeks after infusion, the follow-up will last for at least 12 months for disease control.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B-Cell Leukemia, B-Cell Lymphoma, B-cell Tumors
Keywords
B Cell, CAR-T, CD19, Leukemia, Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Patients will receive one of the three doses of 0.5-2*10^6/kg, 3-4*10^6/kg, 5-6*10^6/kg.
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
OlyCAR-019 Cell Infusion
Arm Type
Experimental
Arm Description
OlyCAR-019 cell infusion will be administered by vein after short-time manufacture.
Intervention Type
Biological
Intervention Name(s)
Anti-CD19 Autologous CAR-T Cell Infusion
Other Intervention Name(s)
OlyCAR-019
Intervention Description
Autologous T cells modified with anti-CD19 ScFv expression and manufactured by OlyCAR platform
Primary Outcome Measure Information:
Title
Incidence of adverse events(AE) after infusion
Description
The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included.
Time Frame
Up to 12 months after infusion
Title
MTD
Description
MTD will be determined based on DLTs observed during the first 28 days of study treatment.
Time Frame
Up to 28 days after infusion
Secondary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
Overall Response Rate (ORR) is defined as the proportion of subjects achieving complete remission(CR) and partial response(PR).
Time Frame
Up to 3 months after infusion
Title
Progression-free survival(PFS)
Description
Progression-free survival(PFS) refers to the time from cell infusion to the first assessment of tumor progression or death from any cause.
Time Frame
Up to 3 months after infusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: A definite diagnosis of relapsed/refractory B-cell malignancies; Male or female, aged 2-75 years; Confirmed detectable disease; Expected survival time >12 weeks; Eastern cooperative oncology group (ECOG) score is 0-2; Adequate liver , kidney and cardiopulmonary function; Women of childbearing age have negative blood pregnancy test before the start of the trial, and agree to take effective contraceptive measures during the trial until the last follow-up; male subjects with partners of childbearing potential agree to take effective contraceptive measures during the trial until the last follow-up; Willingness to complete the informed consent process and to comply with study procedures and visit schedule. Key Exclusion Criteria: Presence of other concurrent active malignancy; People with severe mental disorders; History of any of the following genetic disorders, such as Fanconi anemia, Schu-Day syndrome, Gerstmann syndrome, or any other known bone marrow failure syndrome; Acute GVHD of grade II-IV or extensive chronic GVHD; Grade III-IV heart failure or myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, or other clinically prominent heart disease within one year prior to enrollment; The presence of any indwelling catheter or drainage (e.g., percutaneous nephrostomy, indwelling catheter, bile drainage, or pleural/peritoneal/pericardial catheter), except for patients who are permitted to use dedicated central venous catheters; Human immunodeficiency virus (HIV) seropositivity; Hepatitis B surface antigen positive or hepatitis B core antibody positive, and HBV-DNA positive; Patients with hepatitis C (HCV-RNA quantitative test results positive); Or the presence of other serious active viral or bacterial infections or uncontrolled systemic fungal infections; Patients with severe history of allergy or allergic constitution; A history of autoimmune diseases (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) leading to end-organ damage or requiring systemic immunosuppressive/systemic disease modulating drugs within the past 2 years; Had or is suffering from interstitial lung disease (e.g., pneumonia, pulmonary fibrosis); Had undergone other clinical trials in the 4 weeks prior to participating in this trial; Poor compliance due to physiological, family, social, geographical and other factors, unable to cooperate with the study protocol and follow-up plan; For patients contraindicated with cyclophosphamide and fludarabine chemotherapy; Subjects requiring systemic corticosteroid therapy (prednisone ≥5mg/ day or equivalent dose of another corticosteroid) or other immunosuppressive agents within 1 month after UCAR-T cell reinfusion, except for adverse events; Receiving donor lymphocyte infusion within 6 weeks before enrollment; Pregnant and lactating women; Subjects with any other condition which the investigator considers unsuitable for inclusion in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sanbin Wang, Professor
Phone
13187424131
Ext
+86
Email
Sanbin1011@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shiqi Li, MD
Phone
15398671578
Email
Lystch@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanbin Wang, Professor
Organizational Affiliation
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Official's Role
Principal Investigator
Facility Information:
Facility Name
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650100
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lihua Zhang
Phone
64774204
Ext
+0871
Email
zhanglihua95@126.com
First Name & Middle Initial & Last Name & Degree
Sanbin Wang, MD

12. IPD Sharing Statement

Learn more about this trial

A Study of Novel Anti-CD19 CAR-T in Patients With r/r B-Cell Malignancies

We'll reach out to this number within 24 hrs