Back to resultsA Study of CAR-T Cells Targeting Both BCMA and GPRC5D in Treatment of Relapsed or Refractory Multiple Myeloma
Primary Purpose
Multiple Myeloma
Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
BMCA and GPRC5D dual target CAR-T cells(OriC321)
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma
Eligibility Criteria
Inclusion Criteria:
- Signed and dated, written informed consent prior to any study specific procedures;
- Estimated life expectancy of minimum of 12 weeks;
- ECOG 0-2;
- Diagnosed as multiple myeloma according to the IMWG criteria;
Evidence of cell membrane GPRC5D and/or BCMA expression, as determined by a validated immunohistochemistry (IHC) or flow cytometry of tumor tissue; Subjects should have measurable disease. At least meet one of the following criteria:
- If IgG type MM, serum M protein ≥10g/L; if IgA, IgD, IgE or IgM type MM, serum M protein ≥5g/L;
- urine M protein level ≥0.2g(200mg/24h);
- light chain type MM, serum free light chain (sFLC) ≥ 100mg / L and K/ λ FLC ratio is abnormal;
- there are extramedullary lesions;
- Subjects have had at least 3 prior lines of therapy including chemotherapy based on proteasome inhibitors (PIs) and immunomodulatory agents (IMiDs);
- Adequate organ functions
Exclusion Criteria:
- Active smoldering multiple myeloma;
- Active plasma cell leukemia;
- With organ amyloidosis;
- Central nervous system (CNS) involvement;
- Pregnant or breastfeeding;
- Hepatitis B virus (HBV) surface antigen (HBsAg) or hepatitis B core antibody-positive and detectable HBV DNA in peripheral blood; Hepatitis C virus (HCV) antibody and hepatitis C virus RNA in peripheral blood; Human immunodeficiency virus (HIV) antibody
- Uncontrolled Hypertension hypertension defined as a blood pressure (BP) ≥150/95 mmHg; Symptomatic heart failure per New York Heart Association Classification Class II, III or IV), Mean resting corrected QT interval corrected by Fridericia's formula (QTcF) > 470 msec (female), 450 msec (male) obtained from ECG; Baseline left ventricular ejection fraction (LVEF) below institution's lower limit of normal (LLN) or <50%;
- Have a history of another primary malignancy within 5 years prior to starting study treatment. Exceptions here are as follows: the disease under study; adequately treated basal or squamous cell carcinoma of the skin; cancer of the cervix in situ.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BMCA and GPRC5D dual target CAR-T cells （OriC321）
Arm Description
Outcomes
Primary Outcome Measures
Incidence, severity AEs/SAEs
Secondary Outcome Measures
Concentration of CAR-T cells
Objective response rate (ORR)
Progression-free survival (PFS)
Duration of response (DOR)
Overall survival (OS)
Percentage of Patients With Negative Minimal Residual Disease (MRD)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05325801
Brief Title
A Study of CAR-T Cells Targeting Both BCMA and GPRC5D in Treatment of Relapsed or Refractory Multiple Myeloma
Official Title
An Open-Label, Dose Finding Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of BMCA and GPRC5D Dual Target CAR-T Cells Therapy in Patients With Relapsed or Refractory Multiple Myeloma
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 2022 (Anticipated)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang University
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
An Open-Label, Dose Finding Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of BMCA and GPRC5D dual target CAR-T cells therapy in Patients with relapsed or refractory multiple myeloma
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
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BMCA and GPRC5D dual target CAR-T cells （OriC321）
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
BMCA and GPRC5D dual target CAR-T cells(OriC321)
Intervention Description
Patients will receive lymphodepleting chemotherapy followed by a single infusion of OriC321
Primary Outcome Measure Information:
Title
Incidence, severity AEs/SAEs
Time Frame
2 years after CAR-T cell infusion
Secondary Outcome Measure Information:
Title
Concentration of CAR-T cells
Time Frame
2 years after CAR-T cell infusion
Title
Objective response rate (ORR)
Time Frame
2 years after CAR-T cell infusion
Title
Progression-free survival (PFS)
Time Frame
2 years after CAR-T cell infusion
Title
Duration of response (DOR)
Time Frame
2 years after CAR-T cell infusion
Title
Overall survival (OS)
Time Frame
2 years after CAR-T cell infusion
Title
Percentage of Patients With Negative Minimal Residual Disease (MRD)
Time Frame
2 years after CAR-T cell infusion
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:
Signed and dated, written informed consent prior to any study specific procedures;
Estimated life expectancy of minimum of 12 weeks;
ECOG 0-2;
Diagnosed as multiple myeloma according to the IMWG criteria;
Evidence of cell membrane GPRC5D and/or BCMA expression, as determined by a validated immunohistochemistry (IHC) or flow cytometry of tumor tissue; Subjects should have measurable disease. At least meet one of the following criteria:
If IgG type MM, serum M protein ≥10g/L; if IgA, IgD, IgE or IgM type MM, serum M protein ≥5g/L;
urine M protein level ≥0.2g(200mg/24h);
light chain type MM, serum free light chain (sFLC) ≥ 100mg / L and K/ λ FLC ratio is abnormal;
there are extramedullary lesions;
Subjects have had at least 3 prior lines of therapy including chemotherapy based on proteasome inhibitors (PIs) and immunomodulatory agents (IMiDs);
Adequate organ functions
Exclusion Criteria:
Active smoldering multiple myeloma;
Active plasma cell leukemia;
With organ amyloidosis;
Central nervous system (CNS) involvement;
Pregnant or breastfeeding;
Hepatitis B virus (HBV) surface antigen (HBsAg) or hepatitis B core antibody-positive and detectable HBV DNA in peripheral blood; Hepatitis C virus (HCV) antibody and hepatitis C virus RNA in peripheral blood; Human immunodeficiency virus (HIV) antibody
Uncontrolled Hypertension hypertension defined as a blood pressure (BP) ≥150/95 mmHg; Symptomatic heart failure per New York Heart Association Classification Class II, III or IV), Mean resting corrected QT interval corrected by Fridericia's formula (QTcF) > 470 msec (female), 450 msec (male) obtained from ECG; Baseline left ventricular ejection fraction (LVEF) below institution's lower limit of normal (LLN) or <50%;
Have a history of another primary malignancy within 5 years prior to starting study treatment. Exceptions here are as follows: the disease under study; adequately treated basal or squamous cell carcinoma of the skin; cancer of the cervix in situ.
12. IPD Sharing Statement
Learn more about this trial
A Study of CAR-T Cells Targeting Both BCMA and GPRC5D in Treatment of Relapsed or Refractory Multiple Myeloma
We'll reach out to this number within 24 hrs