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A Study of C-CAR039 (Prizloncabtagene Autoleucel) in Patients With Relapsed/Refractory Large B-Cell Lymphoma (ELEVATION)

Primary Purpose

Relapsed/Refractory Large B-Cell Lymphoma

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Prizloncabtagene autoleucel
Sponsored by
Cellular Biomedicine Group Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsed/Refractory Large B-Cell Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: ≥ 18 years of age Histologically confirmed CD19 or CD20 positive B-cell non-Hodgkin lymphoma, including the following neoplasms as defined by the 2016 WHO classification of lymphoid neoplasms: Diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) Primary mediastinal large B-cell lymphoma (PMBCL) Transformed follicular lymphoma (tFL) High-grade B-cell lymphoma, with MYC and BCL2 and/or BCL6 rearrangements (HGBL-DH/TH) High-grade B-cell lymphoma, NOS (HGBL, NOS) Follicular lymphoma grade 3B (FL3B) Relapsed or refractory disease after ≥ 2 lines of standard therapy or relapsed after autologous stem cell transplantation (ASCT) At least one measurable lesion per the Lugano 2014 Classification Adequate organ and marrow function Exclusion Criteria: Prior allogeneic hematopoietic stem cell transplantation (HSCT) at anytime, or ASCT within 12 weeks prior to apheresis Suspected or confirmed central nervous system involvement Stroke or convulsion history within 6 months of signing informed consent form (ICF) Autoimmune disease, immunodeficiency or diseases requiring immunosuppressants treatment Uncontrolled active infection Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with detectable hepatitis B virus (HBV) DNA in peripheral blood; positive hepatitis C virus (HCV) antibody with positive HCV RNA in peripheral blood; positive human immunodeficiency virus (HIV) antibody; positive syphilis test Severe heart, liver, renal or metabolism disease Inadequate wash-out time for previous anti-tumor treatments prior to apheresis Prior CAR-T therapy

Sites / Locations

  • Peking Cancer HospitalRecruiting
  • The First Affiliated Hospital, Zhejiang University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prizloncabtagene Autoleucel

Arm Description

Prizlon-cel will be intravenously administered as a single infusion after lymphodepletion.

Outcomes

Primary Outcome Measures

Phase 1b: Incidence and Severity of Adverse Events (AEs)
Incidence and severity of any AEs , including dose limiting toxicities (DLTs)
Phase 1b: Recommended Phase 2 Dose (R2PD)
Based on DLTs rates and overall safety profile
Phase 2: Overall Response Rate (ORR) at 3 months
Best response rate at 3 months after C-CAR039 infusion, including partial response (PR) and complete response (CR)

Secondary Outcome Measures

Phase 1b: ORR at 3 months
Best response rate at 3 months after C-CAR039 infusion, including PR and CR
Phase 2: Incidence and Severity of Adverse Events (AEs)
Incidence and severity of any AEs
ORR
Best response, including PR and CR
ORR at 6 months
Best response rate at 6 months after C-CAR039 infusion, including PR and CR
Duration of response (DOR)
The time from the first documented PR or CR to disease progression or death, whichever occurs first
Time to response (TTR)
The time from the date of C-CAR039 infusion to the first documented PR or CR
Progression-free survival (PFS)
The time from the date of C-CAR039 infusion to the date of first documented disease progression or death
Overall survival (OS)
The time from the date of C-CAR039 infusion to the date of death
Maximal plasma concentration (Cmax)
Maximal plasma concentration of C-CAR039 in peripheral blood
Time to reach the maximal plasma concentration (Tmax)
Time to reach the maximal plasma concentration of C-CAR039 in peripheral blood
Area under the curve within 28 days (AUC0-28d)
Area under the curve of C-CAR039 in peripheral blood within 28 days post infusion
Time of last measurable observed concentration (Tlast)
Time of last measurable observed concentration of C-CAR039 in peripheral blood
The B cell percentage changes and CD19/CD20 expression changes in blood
The B cell percentage changes and CD19/CD20 expression changes in blood by flow cytometry assay before and after C-CAR039 infusion
Anti-drug (C-CAR039) antibody
Presence of serum anti-drug (C-CAR039) antibody

Full Information

First Posted
March 24, 2023
Last Updated
March 24, 2023
Sponsor
Cellular Biomedicine Group Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05800977
Brief Title
A Study of C-CAR039 (Prizloncabtagene Autoleucel) in Patients With Relapsed/Refractory Large B-Cell Lymphoma
Acronym
ELEVATION
Official Title
A Phase 1b/2 Study of a Anti-CD19/CD20 Bispecific CAR-T Therapy (C-CAR039/Prizloncabtagene Autoleucel) in Patients With Relapsed/Refractory Large B-Cell Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 22, 2023 (Actual)
Primary Completion Date
March 31, 2027 (Anticipated)
Study Completion Date
March 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cellular Biomedicine Group Ltd.

4. Oversight

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

5. Study Description

Brief Summary
This is a multicenter, single arm, open-label study. The purpose of the study is to evaluate safety of Prizloncabtagene Autoleucel (Prizlon-cel) and establish the recommended Phase 2 dose (RP2D) (Phase 1b) and to evaluate the efficacy of Prizlon-cel (Phase 2) in patients with relapsed or refractory large b-cell lymphoma (LBCL).
Detailed Description
The purpose of the study is to evaluate the safety and efficacy of Prizlon-cel. It includes two phases, Phase 1b and Phase 2. In Phase 1b study, RP2D will be determined. The selected dose will be further evaluated in the Phase 2 study. The study includes the following sequential procedures: Screening, Apheresis and CAR-T manufacturing, Baseline, Lymphodepletion, CAR-T infusion, DLT period (Phase 1b) and Follow-up Visit. Subjects will be followed for at least 2 years after Prizlon-cel infusion, with up to 15 years long-term follow-up on a separate study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed/Refractory Large B-Cell Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prizloncabtagene Autoleucel
Arm Type
Experimental
Arm Description
Prizlon-cel will be intravenously administered as a single infusion after lymphodepletion.
Intervention Type
Biological
Intervention Name(s)
Prizloncabtagene autoleucel
Other Intervention Name(s)
C-CAR039
Intervention Description
Prizlon-cel is a novel 2nd generation 4-1BB bispecific chimeric antigen receptor T-cell (CAR-T) targeting both CD19 and CD20 antigens
Primary Outcome Measure Information:
Title
Phase 1b: Incidence and Severity of Adverse Events (AEs)
Description
Incidence and severity of any AEs , including dose limiting toxicities (DLTs)
Time Frame
Up to 2 years after C-CAR039 infusion
Title
Phase 1b: Recommended Phase 2 Dose (R2PD)
Description
Based on DLTs rates and overall safety profile
Time Frame
Up to 2 years after C-CAR039 infusion
Title
Phase 2: Overall Response Rate (ORR) at 3 months
Description
Best response rate at 3 months after C-CAR039 infusion, including partial response (PR) and complete response (CR)
Time Frame
Up to 3 months after C-CAR039 infusion
Secondary Outcome Measure Information:
Title
Phase 1b: ORR at 3 months
Description
Best response rate at 3 months after C-CAR039 infusion, including PR and CR
Time Frame
Up to 3 months after C-CAR039 infusion
Title
Phase 2: Incidence and Severity of Adverse Events (AEs)
Description
Incidence and severity of any AEs
Time Frame
Up to 2 years after C-CAR039 infusion
Title
ORR
Description
Best response, including PR and CR
Time Frame
Up to 2 years after C-CAR039 infusion
Title
ORR at 6 months
Description
Best response rate at 6 months after C-CAR039 infusion, including PR and CR
Time Frame
Up to 6 months after C-CAR039 infusion
Title
Duration of response (DOR)
Description
The time from the first documented PR or CR to disease progression or death, whichever occurs first
Time Frame
Up to 2 years after C-CAR039 infusion
Title
Time to response (TTR)
Description
The time from the date of C-CAR039 infusion to the first documented PR or CR
Time Frame
Up to 2 years after C-CAR039 infusion
Title
Progression-free survival (PFS)
Description
The time from the date of C-CAR039 infusion to the date of first documented disease progression or death
Time Frame
Up to 2 years after C-CAR039 infusion
Title
Overall survival (OS)
Description
The time from the date of C-CAR039 infusion to the date of death
Time Frame
Up to 2 years after C-CAR039 infusion
Title
Maximal plasma concentration (Cmax)
Description
Maximal plasma concentration of C-CAR039 in peripheral blood
Time Frame
Up to 2 years after C-CAR039 infusion
Title
Time to reach the maximal plasma concentration (Tmax)
Description
Time to reach the maximal plasma concentration of C-CAR039 in peripheral blood
Time Frame
Up to 2 years after C-CAR039 infusion
Title
Area under the curve within 28 days (AUC0-28d)
Description
Area under the curve of C-CAR039 in peripheral blood within 28 days post infusion
Time Frame
Up to 28 days after C-CAR039 infusion
Title
Time of last measurable observed concentration (Tlast)
Description
Time of last measurable observed concentration of C-CAR039 in peripheral blood
Time Frame
Up to 2 years after C-CAR039 infusion
Title
The B cell percentage changes and CD19/CD20 expression changes in blood
Description
The B cell percentage changes and CD19/CD20 expression changes in blood by flow cytometry assay before and after C-CAR039 infusion
Time Frame
Up to 2 years after C-CAR039 infusion
Title
Anti-drug (C-CAR039) antibody
Description
Presence of serum anti-drug (C-CAR039) antibody
Time Frame
Up to 2 years after C-CAR039 infusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥ 18 years of age Histologically confirmed CD19 or CD20 positive B-cell non-Hodgkin lymphoma, including the following neoplasms as defined by the 2016 WHO classification of lymphoid neoplasms: Diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) Primary mediastinal large B-cell lymphoma (PMBCL) Transformed follicular lymphoma (tFL) High-grade B-cell lymphoma, with MYC and BCL2 and/or BCL6 rearrangements (HGBL-DH/TH) High-grade B-cell lymphoma, NOS (HGBL, NOS) Follicular lymphoma grade 3B (FL3B) Relapsed or refractory disease after ≥ 2 lines of standard therapy or relapsed after autologous stem cell transplantation (ASCT) At least one measurable lesion per the Lugano 2014 Classification Adequate organ and marrow function Exclusion Criteria: Prior allogeneic hematopoietic stem cell transplantation (HSCT) at anytime, or ASCT within 12 weeks prior to apheresis Suspected or confirmed central nervous system involvement Stroke or convulsion history within 6 months of signing informed consent form (ICF) Autoimmune disease, immunodeficiency or diseases requiring immunosuppressants treatment Uncontrolled active infection Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with detectable hepatitis B virus (HBV) DNA in peripheral blood; positive hepatitis C virus (HCV) antibody with positive HCV RNA in peripheral blood; positive human immunodeficiency virus (HIV) antibody; positive syphilis test Severe heart, liver, renal or metabolism disease Inadequate wash-out time for previous anti-tumor treatments prior to apheresis Prior CAR-T therapy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuqin Song, M.D., PhD
Phone
86-10-88196116
Email
SongYQ_VIP@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuqin Song, M.D., PhD
Organizational Affiliation
Peking Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Cancer Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuqin Song, M.D., PhD
Facility Name
The First Affiliated Hospital, Zhejiang University School of Medicine
City
Hangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Jin, M.D., PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study of C-CAR039 (Prizloncabtagene Autoleucel) in Patients With Relapsed/Refractory Large B-Cell Lymphoma

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