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A Study of C-CAR088 in Patients With Relapsed or Refractory Multiple Myeloma

Primary Purpose

Multiple Myeloma

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
B-cell maturation antigen (BCMA) directed chimeric antigen receptor (CAR)-T cell
Sponsored by
Cellular Biomedicine Group Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma

Eligibility Criteria

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

Inclusion Criteria

  • ≥ 18 years of age, male or female patients
  • Relapsed or refractory multiple myeloma
  • Have been treated with ≥ 3 prior lines of therapy, including at least one proteasome inhibitor and one immunomodulatory drug, and had progressed during or within 12 months post the last treatment.

  • Had measurable disease as defined by any of the following criteria:

    • Serum M protein ≥ 0.5g/dL
    • Urine M protein ≥ 200mg/24h
    • Serum free light chain (sFLC): abnormal κ/λ ratio with involved sFLC ≥ 100mg/L
  • Adequate liver, renal, bone marrow, and heart function
  • Eastern cooperative oncology group (ECOG) 0-1

Exclusion Criteria

  • Any known allergies to the components or excipients of the C-CAR088 cell product
  • Prior allogeneic hematopoietic stem cell transplantation (HSCT) at anytime, or autologous stem-cell transplantation (ASCT) within 12 weeks prior to apheresis
  • Central nervous system (CNS) involvement
  • Stroke or convulsion history within 6 months prior to signing informed consent form (ICF)
  • Plasma leukemia
  • Autoimmune disease, immunodeficiency or diseases requiring immunosuppressants treatment
  • Uncontrolled active infection; active hepatitis B virus (HBV), hepatitis C virus (HCV) infection; HIV or syphilis infection
  • Severe heart, liver, renal or metabolism disease
  • Inadequate wash-out time for previous anti-tumor treatments prior to apheresis
  • Previous CAR-T cell treatment, genetically modified T-cell therapies or BCMA-directed treatment history
  • History or current evidence of any condition, therapy, or laboratory abnormality that, in the opinion of the investigator, might confound the results of the trial, interfere with the patient's safe participation and compliance in the trial

Sites / Locations

  • Institute of Hematology and Blood Diseases HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

C-CAR088

Arm Description

Autologous C-CAR088 administered by intravenous (IV) infusion

Outcomes

Primary Outcome Measures

[phase Ib] Incidence and severity of Adverse Events
Incidence and severity of Adverse Events
[phase II] Overall response rate (ORR) at 3 months after C-CAR088 infusion
the rate of patients with best response of partial response (PR) or better at 3 months after C-CAR088 infusion

Secondary Outcome Measures

Overall response rate (ORR)
The rate of patients with best response of partial response (PR) or better
[phase Ib] Overall response rate (ORR) at 3 months after C-CAR088 infusion
The rate of patients with best response of partial response (PR) or better at 3 months after C-CAR088 infusion
Duration of response (DOR)
The time from the first documented PR or better response to relapse or death, whichever occurs first
Time to response (TTR)
The time from the date of C-CAR088 infusion to the first documented PR or better
Progression-free survival (PFS)
The time from the date of C-CAR088 infusion to the date of first documented disease progression or death
Overall survival (OS)
The time from the date of C-CAR088 infusion to the date of death
Minimal residual disease (MRD) negativity rate
The rate of patients reached MRD negativity
[phase II] Incidence and severity of Adverse Events
Incidence and severity of Adverse Events
Maximal plasma concentration (Cmax)
maximal plasma concentration of C-CAR088 in peripheral blood
Time to reach the maximal plasma concentration (Tmax)
Time to reach the maximal plasma concentration of C-CAR088 in peripheral blood
Area under the curve within 28 days (AUC0-28d)
Area under the curve of C-CAR088 in peripheral blood within 28 days post infusion
Time of last measurable observed concentration (Tlast)
Time of last measurable observed concentration of C-CAR088 in peripheral blood
Anti-drug (C-CAR088) antibody
Presence of serum anti-drug (C-CAR088) antibody
Serum M protein
serum M proteins concentration changes over time
Urine M protein
Urine M proteins concentration changes over time
Serum free light chain (sFLC)
Serum free light chain (sFLC) concentration changes over time

Full Information

First Posted
August 28, 2022
Last Updated
March 22, 2023
Sponsor
Cellular Biomedicine Group Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05521802
Brief Title
A Study of C-CAR088 in Patients With Relapsed or Refractory Multiple Myeloma
Official Title
A Phase Ib/II Study of CBM.BCMA Chimeric Antigen Receptor T Cell Product (C-CAR088) for Treating Patients With Relapsed or Refractory Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 11, 2022 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2037 (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, open-label study to evaluate the safety and efficacy of C-CAR088 in patients with relapsed or refractory multiple myeloma. The phase Ib part of this study is to determine the recommended phase 2 dose (RP2D) of C-CAR088 in the targeted patient population.
Detailed Description
The study includes the following sequential procedures: Screening, Apheresis and C-CAR088 manufacturing, Baseline testing, Lymphodepletion, C-CAR088 infusion, and Follow-up Visit. Two dose levels of C-CAR088 will be tested during the phase Ib part to determine RP2D, which will be further evaluated during the phase II part.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma

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
92 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
C-CAR088
Arm Type
Experimental
Arm Description
Autologous C-CAR088 administered by intravenous (IV) infusion
Intervention Type
Biological
Intervention Name(s)
B-cell maturation antigen (BCMA) directed chimeric antigen receptor (CAR)-T cell
Intervention Description
Autologous 2nd generation BCMA-directed CAR-T cells, single infusion intravenously
Primary Outcome Measure Information:
Title
[phase Ib] Incidence and severity of Adverse Events
Description
Incidence and severity of Adverse Events
Time Frame
24 months
Title
[phase II] Overall response rate (ORR) at 3 months after C-CAR088 infusion
Description
the rate of patients with best response of partial response (PR) or better at 3 months after C-CAR088 infusion
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Overall response rate (ORR)
Description
The rate of patients with best response of partial response (PR) or better
Time Frame
24 months
Title
[phase Ib] Overall response rate (ORR) at 3 months after C-CAR088 infusion
Description
The rate of patients with best response of partial response (PR) or better at 3 months after C-CAR088 infusion
Time Frame
3 months
Title
Duration of response (DOR)
Description
The time from the first documented PR or better response to relapse or death, whichever occurs first
Time Frame
24 months
Title
Time to response (TTR)
Description
The time from the date of C-CAR088 infusion to the first documented PR or better
Time Frame
24 months
Title
Progression-free survival (PFS)
Description
The time from the date of C-CAR088 infusion to the date of first documented disease progression or death
Time Frame
24 months
Title
Overall survival (OS)
Description
The time from the date of C-CAR088 infusion to the date of death
Time Frame
24 months
Title
Minimal residual disease (MRD) negativity rate
Description
The rate of patients reached MRD negativity
Time Frame
24 months
Title
[phase II] Incidence and severity of Adverse Events
Description
Incidence and severity of Adverse Events
Time Frame
24 months
Title
Maximal plasma concentration (Cmax)
Description
maximal plasma concentration of C-CAR088 in peripheral blood
Time Frame
24 months
Title
Time to reach the maximal plasma concentration (Tmax)
Description
Time to reach the maximal plasma concentration of C-CAR088 in peripheral blood
Time Frame
24 months
Title
Area under the curve within 28 days (AUC0-28d)
Description
Area under the curve of C-CAR088 in peripheral blood within 28 days post infusion
Time Frame
28 days
Title
Time of last measurable observed concentration (Tlast)
Description
Time of last measurable observed concentration of C-CAR088 in peripheral blood
Time Frame
24 months
Title
Anti-drug (C-CAR088) antibody
Description
Presence of serum anti-drug (C-CAR088) antibody
Time Frame
24 months
Title
Serum M protein
Description
serum M proteins concentration changes over time
Time Frame
24 months
Title
Urine M protein
Description
Urine M proteins concentration changes over time
Time Frame
24 months
Title
Serum free light chain (sFLC)
Description
Serum free light chain (sFLC) concentration changes over time
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria ≥ 18 years of age, male or female patients Relapsed or refractory multiple myeloma Have been treated with ≥ 3 prior lines of therapy, including at least one proteasome inhibitor and one immunomodulatory drug, and had progressed during or within 12 months post the last treatment. Had measurable disease as defined by any of the following criteria: Serum M protein ≥ 0.5g/dL Urine M protein ≥ 200mg/24h Serum free light chain (sFLC): abnormal κ/λ ratio with involved sFLC ≥ 100mg/L Adequate liver, renal, bone marrow, and heart function Eastern cooperative oncology group (ECOG) 0-1 Exclusion Criteria Any known allergies to the components or excipients of the C-CAR088 cell product Prior allogeneic hematopoietic stem cell transplantation (HSCT) at anytime, or autologous stem-cell transplantation (ASCT) within 12 weeks prior to apheresis Central nervous system (CNS) involvement Stroke or convulsion history within 6 months prior to signing informed consent form (ICF) Plasma leukemia Autoimmune disease, immunodeficiency or diseases requiring immunosuppressants treatment Uncontrolled active infection; active hepatitis B virus (HBV), hepatitis C virus (HCV) infection; HIV or syphilis infection Severe heart, liver, renal or metabolism disease Inadequate wash-out time for previous anti-tumor treatments prior to apheresis Previous CAR-T cell treatment, genetically modified T-cell therapies or BCMA-directed treatment history History or current evidence of any condition, therapy, or laboratory abnormality that, in the opinion of the investigator, might confound the results of the trial, interfere with the patient's safe participation and compliance in the trial
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lugui Qiu, M.D., PH.D.
Phone
022-23909083
Email
Qiulg@ihcams.ac.cn
First Name & Middle Initial & Last Name or Official Title & Degree
An Gang, M.D., PH.D.
Phone
022-23909171
Email
angang@ihcams.ac.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lugui Qiu
Organizational Affiliation
Institute of Hematology & Blood Diseases Hospital, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Hematology and Blood Diseases Hospital
City
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lugui Qiu, M.D., Ph.D.
Phone
022-23909083
Email
Qiulg@ihcams.ac.cn

12. IPD Sharing Statement

Learn more about this trial

A Study of C-CAR088 in Patients With Relapsed or Refractory Multiple Myeloma

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