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Assess the Safety and Efficacy of CT0594CP Cells in Relapsed/Refractory Multiple Myeloma or Plasma Cell Leukemia

Primary Purpose

Relapsed and/or Refractory Multiple Myeloma, Plasma Cell Leukemia in Relapse

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Biological
Sponsored by
Aibin Liang,MD,Ph.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsed and/or Refractory Multiple Myeloma

Eligibility Criteria

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

Inclusion Criteria: Patients and legally acceptable representative must have voluntarily signed ICF and willing to complete the study procedure, after fully understanding of the study. Age ≥ 18 years and ≤ 75 years, male or female. The patients, with MM or Plasma Cell Leukemia, who have received regimens and have medical records in the past. According to the IMWG consensus for relapsed and/or refractory multiple myeloma or Plasma Cell Leukemia, the disease is in a progressive state Subjects should have measurable disease. 5.1 Serum M protein ≥ 5 g / L; 5.2 24-hour urinary M-protein ≥ 200 mg; 5.3 The serum free light chain (sFLC) ratio was abnormal and the involved FLC ≥ 100mg/L in patients with light chain multiple myeloma whose serum or urinary M protein levels did not meet the assessable criteria. 5.4 Circulating plasma cells ≥2% Expected survival > 12 weeks. Eastern Cooperative Oncology Group (ECOG) scores 0-1. Subjects should have adequate function in hemostatic and liver and kidney. Women of childbearing age must undergo a serum pregnancy test with negative results at screening and before lymphodepletion and be willing to use an effective and reliable method of contraception for at least 1 year after study treatment. All female subjects are prohibited from egg donation within 1 year after study treatment. Men must be willing to use an effective and reliable method of contraception for at least 1 year after study treatment if they have sexual activity with women of childbearing potential. All male subjects are prohibited from sperm donation within 1 year after study treatment . Exclusion Criteria: Pregnant or lactating women. Subjects positive for any following tests: human immunodeficiency virus (HIV) antibody, Treponema pallidum (syphilis) antibody, CMV(IgM),EBV; Active hepatitis B and/or active hepatitis C (HCV RNA positive); Those who are positive for hepatitis B surface antigen and/or core antibodies but whose HBV-DNA test is within normal limits may be enrolled. Subjects with any uncontrolled active infection (Except for prophylactic treatment). Subjects with AEs from previous treatment that have not recovered to Common Terminology Criteria for Adverse Events (CTCAE) ≤ 1, excluding hair loss and other events that the treating physician considers as tolerable. Subjects who have received autologous BCMA CAR-T therapy Subjects who have received allogeneic stem cell transplantation for MM. Subjects who have received autologous stem cell transplantation less than 12 weeks before ICF. Subjects who have received any anti-MM treatment 14 days before ICF; the subjects are eligible to participate in the study regardless of the radiotherapy end date if the radiation area less than 5% of whole body. Subjects who have received systemic glucocorticoids within 7 days before infusion, except inhaled steroids. Subjects who have been received live attenuated vaccine within 8 weeks or inactivated vaccine within 4 weeks before lymphodepletion. Subjects have severe allergy history. Subjects who have any uncontrolled disease conditions within 6 months prior to the screening. LVEF < 50% Blood oxygen saturation that can only be maintained at > 95% by oxygen inhalation. Subjects known to have active autoimmune diseases including but not limited to psoriasis, rheumatoid arthritis and other conditions that require long-term immunosuppressive therapy. Subjects with malignant tumors that have not been cured in the past 5 years or at the same time, except for very low malignant tumors. Subjects who have central nervous system (CNS) metastases or symptomatic CNS involvement. Subjects who are unable or unwilling to comply with the requirements of clinical trial or other reasons that are not suitable for participating in the clinical trial. Subjects who have received major surgery 2 weeks prior to the screening or plan to receive major surgery within 4 weeks after study treatment (excluding cataract and other local anesthesia).

Sites / Locations

  • Shanghai Tongji HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CT0594CP CAR-T Cells [BCMA-UCAR-T (CT0594)andCD94-UCAR-T(CT7590) ]

Arm Description

CT0594CP

Outcomes

Primary Outcome Measures

Safety and tolerability dose limiting toxicity
Safety and tolerability: dose limiting toxicity [Time Frame: 21-28 days post administration of CT0594CP ]

Secondary Outcome Measures

Pharmacokinetics of CT0594CP CAR-T Cells (Tmax)
peak plasma Concentration time(Tmax), of after infusion CT0594CP CAR T Cells
Pharmacokinetics of CT0594CP CAR-T Cells (Cmax)
peak plasma Concentration(Cmax), of after infusion CT0594CP CAR T Cells
Pharmacokinetics of CT0594CP CAR-T Cells (AUC)
area under the Plasma concentration versus time curve (AUC), of after infusion CT0594CP CAR T Cells
To evaluate the overall safety and tolerability of CT0594CP
Post-treatment Adverse events (TEAE) and incidence, Special Concern Adverse Events (AESI) and incidence, treatment-related adverse events
To evaluate the initial efficacy of CT0594CP infusion in target subjects
Overall response rate (ORR)、 Complete response/strict complete response (CR/sCR) rate、Response rates of VGPR and above were achieved 、Duration of response (DOR)、Progression-free survival (PFS)、Overall survival (overall survival (OS)、Minimal residual disease (MRD) negative rate as measured by International Myeloma Working Group (IMWG) criteria after CT0594CP infusion

Full Information

First Posted
April 4, 2023
Last Updated
May 29, 2023
Sponsor
Aibin Liang,MD,Ph.D.
Collaborators
CARsgen Therapeutics Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05893693
Brief Title
Assess the Safety and Efficacy of CT0594CP Cells in Relapsed/Refractory Multiple Myeloma or Plasma Cell Leukemia
Official Title
Open Label, Single Arm Clinical Trial to Evaluate the Safety and Efficacy of CT0594CP in Patients With Relapsed and/or Refractory Multiple Myeloma or Plasma Cell Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 12, 2023 (Actual)
Primary Completion Date
January 1, 2026 (Anticipated)
Study Completion Date
January 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Aibin Liang,MD,Ph.D.
Collaborators
CARsgen Therapeutics Co., Ltd.

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
This is an open-label, single arm study to evaluate the safety and tolerability of treatment with CT0594CP CAR-T Cells in patients with relapsed and/or refractory multiple myeloma or Plasma Cell Leukemia
Detailed Description
This is an open-label, single arm, dose-escalation clinical study, to evaluate the safety and tolerability of treatment with CT0594CP CAR-T Cells in patients with relapsed and/or refractory multiple myeloma or Plasma Cell Leukemia

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed and/or Refractory Multiple Myeloma, Plasma Cell Leukemia in Relapse

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CT0594CP CAR-T Cells [BCMA-UCAR-T (CT0594)andCD94-UCAR-T(CT7590) ]
Arm Type
Experimental
Arm Description
CT0594CP
Intervention Type
Other
Intervention Name(s)
Biological
Intervention Description
CT0594CP
Primary Outcome Measure Information:
Title
Safety and tolerability dose limiting toxicity
Description
Safety and tolerability: dose limiting toxicity [Time Frame: 21-28 days post administration of CT0594CP ]
Time Frame
21-28 days
Secondary Outcome Measure Information:
Title
Pharmacokinetics of CT0594CP CAR-T Cells (Tmax)
Description
peak plasma Concentration time(Tmax), of after infusion CT0594CP CAR T Cells
Time Frame
From first dose of study drug adminisration to end of treatment (up to 12 months)
Title
Pharmacokinetics of CT0594CP CAR-T Cells (Cmax)
Description
peak plasma Concentration(Cmax), of after infusion CT0594CP CAR T Cells
Time Frame
From first dose of study drug adminisration to end of treatment (up to 12 months)
Title
Pharmacokinetics of CT0594CP CAR-T Cells (AUC)
Description
area under the Plasma concentration versus time curve (AUC), of after infusion CT0594CP CAR T Cells
Time Frame
From first dose of study drug adminisration to end of treatment (up to 12 months)
Title
To evaluate the overall safety and tolerability of CT0594CP
Description
Post-treatment Adverse events (TEAE) and incidence, Special Concern Adverse Events (AESI) and incidence, treatment-related adverse events
Time Frame
From first dose of study drug administration to end of treatment (up to 12 months)
Title
To evaluate the initial efficacy of CT0594CP infusion in target subjects
Description
Overall response rate (ORR)、 Complete response/strict complete response (CR/sCR) rate、Response rates of VGPR and above were achieved 、Duration of response (DOR)、Progression-free survival (PFS)、Overall survival (overall survival (OS)、Minimal residual disease (MRD) negative rate as measured by International Myeloma Working Group (IMWG) criteria after CT0594CP infusion
Time Frame
From first dose of study drug administration to end of treatment (up to 12 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients and legally acceptable representative must have voluntarily signed ICF and willing to complete the study procedure, after fully understanding of the study. Age ≥ 18 years and ≤ 75 years, male or female. The patients, with MM or Plasma Cell Leukemia, who have received regimens and have medical records in the past. According to the IMWG consensus for relapsed and/or refractory multiple myeloma or Plasma Cell Leukemia, the disease is in a progressive state Subjects should have measurable disease. 5.1 Serum M protein ≥ 5 g / L; 5.2 24-hour urinary M-protein ≥ 200 mg; 5.3 The serum free light chain (sFLC) ratio was abnormal and the involved FLC ≥ 100mg/L in patients with light chain multiple myeloma whose serum or urinary M protein levels did not meet the assessable criteria. 5.4 Circulating plasma cells ≥2% Expected survival > 12 weeks. Eastern Cooperative Oncology Group (ECOG) scores 0-1. Subjects should have adequate function in hemostatic and liver and kidney. Women of childbearing age must undergo a serum pregnancy test with negative results at screening and before lymphodepletion and be willing to use an effective and reliable method of contraception for at least 1 year after study treatment. All female subjects are prohibited from egg donation within 1 year after study treatment. Men must be willing to use an effective and reliable method of contraception for at least 1 year after study treatment if they have sexual activity with women of childbearing potential. All male subjects are prohibited from sperm donation within 1 year after study treatment . Exclusion Criteria: Pregnant or lactating women. Subjects positive for any following tests: human immunodeficiency virus (HIV) antibody, Treponema pallidum (syphilis) antibody, CMV(IgM),EBV; Active hepatitis B and/or active hepatitis C (HCV RNA positive); Those who are positive for hepatitis B surface antigen and/or core antibodies but whose HBV-DNA test is within normal limits may be enrolled. Subjects with any uncontrolled active infection (Except for prophylactic treatment). Subjects with AEs from previous treatment that have not recovered to Common Terminology Criteria for Adverse Events (CTCAE) ≤ 1, excluding hair loss and other events that the treating physician considers as tolerable. Subjects who have received autologous BCMA CAR-T therapy Subjects who have received allogeneic stem cell transplantation for MM. Subjects who have received autologous stem cell transplantation less than 12 weeks before ICF. Subjects who have received any anti-MM treatment 14 days before ICF; the subjects are eligible to participate in the study regardless of the radiotherapy end date if the radiation area less than 5% of whole body. Subjects who have received systemic glucocorticoids within 7 days before infusion, except inhaled steroids. Subjects who have been received live attenuated vaccine within 8 weeks or inactivated vaccine within 4 weeks before lymphodepletion. Subjects have severe allergy history. Subjects who have any uncontrolled disease conditions within 6 months prior to the screening. LVEF < 50% Blood oxygen saturation that can only be maintained at > 95% by oxygen inhalation. Subjects known to have active autoimmune diseases including but not limited to psoriasis, rheumatoid arthritis and other conditions that require long-term immunosuppressive therapy. Subjects with malignant tumors that have not been cured in the past 5 years or at the same time, except for very low malignant tumors. Subjects who have central nervous system (CNS) metastases or symptomatic CNS involvement. Subjects who are unable or unwilling to comply with the requirements of clinical trial or other reasons that are not suitable for participating in the clinical trial. Subjects who have received major surgery 2 weeks prior to the screening or plan to receive major surgery within 4 weeks after study treatment (excluding cataract and other local anesthesia).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aibin Liang
Phone
+8618601670600
Email
lab7182@tongji.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Ping Li
Phone
+86 13564181131
Email
lilyforever76@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aibin Liang
Organizational Affiliation
+8618601670600
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Tongji Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200333
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aibin Liang
Phone
+8618601670600
Email
lab7182@tongji.edu.cn

12. IPD Sharing Statement

Learn more about this trial

Assess the Safety and Efficacy of CT0594CP Cells in Relapsed/Refractory Multiple Myeloma or Plasma Cell Leukemia

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