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Trial Title:
Frontline Combination CAR-T Cell Therapy for Multiple Myeloma or Plasmacytoma
NCT ID:
NCT06429150
Condition:
Multiple Myeloma
Plasmacytoma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Conditions: Keywords:
multiple myeloma
chimeric antigen receptor
BCMA
GPRC5D
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
CAR-T cells
Description:
Infusion of multi-CAR-T cells
Arm group label:
CAR-T cells to treat MM
Summary:
The aim of this clinical trial is to assess the feasibility, safety, and efficacy of
CAR-T cell therapy targeting multiple cancer cell antigens in high-risk multiple myeloma
or plasmacytoma as part of a frontline treatment regimen for patients. Another goal of
the study is to learn more about the persistence and function of these CAR-T cells in the
body.
Detailed description:
Multiple myeloma (MM) is the second most common malignant hematological cancer in the
world, which begins with the malignant proliferation of plasma cells in bone marrow. It
has been a difficult disease to treat, and most patients will eventually relapse,
especially for those with high-risk genotypes. At present, the therapeutic drugs for MM
include glucocorticoids, cytotoxic drugs, immunosuppressants, protease inhibitors,
monoclonal antibodies and cell therapies. Among those, immunotherapy has been proven to
be a revolutionary treatment with great potential of curing this disease. The frequently
targeted MM antigens include CD38, CD138, CD19 and BCMA, and recently, GPRC5D.
BCMA, the B cell maturation antigen, also known as CD269 or TNFRSF17, is a member of
tumor necrosis factor receptor superfamily, which is highly expressed on the surface of
plasma cells and partially expressed on plasma cell-like dendritic cells. It has been an
ideal target for MM immunotherapy.
GPRC5D, the G-protein-coupled receptor C57 subtype D and a seven-transmembrane protein,
is highly expressed on the surface of plasma cells but not in other healthy cells, and
thus it has become a potential target for the treatment of MM. The expression of GPRC5D
is unrelated to BCMA, so the combination therapy targeting these antigens may bring a
complementary and synergistic therapeutic outcome in patients.
This trial is aimed to test the safety and efficacy of combining these different CAR-T
cells targeting BCMA and GPRC5D, and in combination with well-established therapeutics as
a frontline treatment for the high-risk MM or plasmacytoma patients. Another goal of this
study is to investigate the persistence and function of these CAR-T cells in the body.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Male and female subjects with multiple myeloma or plasmacytoma
- Strictly complete remission (sCR) is a treatment goal
- Expected survival > 12 weeks
- After prior auto-SCT is eligible regardless of other prior therapies
- Adequate venous access for apheresis, and no other contraindications for
leukapheresis
- Voluntary informed consent is given and commitment to continued follow-up
Exclusion Criteria:
- Pregnant or lactating women
- Uncontrolled active infection
- Active HIV, hepatitis B or hepatitis C infection
- Concurrent use of systemic steroids. Recent or current use of inhaled steroids is
not exclusionary.
- Any medical conditions that may preclude participation
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shenzhen Geno-immune Medical Institute
Address:
City:
Shenzhen
Zip:
518000
Country:
China
Status:
Recruiting
Contact:
Last name:
Lung-Ji Chang, ph.D
Phone:
86-0755-86725195
Email:
c@szgimi.com
Investigator:
Last name:
Vitaly Dubov, MD
Email:
Principal Investigator
Facility:
Name:
Hematologist of the Regional Hematology Center in Clinical Hospital No. 2 of the Ministry of Health
Address:
City:
Vladivostok
Zip:
690105
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Vitaly Dubov, MD
Phone:
8(924)3321996
Email:
drvdubov@gmail.com
Start date:
May 11, 2024
Completion date:
December 31, 2027
Lead sponsor:
Agency:
Shenzhen Geno-Immune Medical Institute
Agency class:
Other
Collaborator:
Agency:
The No.2 Clinical Hospital of the Ministry of Health
Agency class:
Other
Source:
Shenzhen Geno-Immune Medical Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06429150
