Actively Recruiting
ASCT in Combination With C-CAR088 for Treating Patients With Ultra High-risk Multiple Myeloma (MM)
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-10-01
20
Participants Needed
1
Research Sites
198 weeks
Total Duration
On this page
Sponsors
I
Institute of Hematology & Blood Diseases Hospital, China
Lead Sponsor
S
Shanghai AbelZeta Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a phase I/II, single-arm, open-lable study of autologous stem cell transplantation in combination with C-CAR088, an autologous BCMA CAR-T cell product, for patients with ulta high-risk multiple myeloma, defined as failed or unsatisfied responses to front line VRD-based treatment with or without the presence of multiple high-risk cytogenetic features.
CONDITIONS
Official Title
ASCT in Combination With C-CAR088 for Treating Patients With Ultra High-risk Multiple Myeloma (MM)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Transplantation eligible patients aged 18 to 65 years
- Diagnosed with ultra high-risk multiple myeloma with poor or unsatisfactory response to frontline VRD-based treatment, with or without multiple high-risk cytogenetic features
- Adequate liver, kidney, bone marrow, and heart function
- Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1
- Male and female participants of reproductive potential agree to use birth control during the study
You will not qualify if you...
- Known allergy to any component of the C-CAR088 product
- Prior allogenic hematopoietic stem cell transplantation or autologous stem cell transplantation
- Central nervous system involvement
- History of stroke or convulsions within 6 months before consent
- Autoimmune disease, immunodeficiency, or requiring immunosuppressant treatment
- Active uncontrolled infection, including active HBV, HCV, HIV, or syphilis infection
- Severe heart, liver, kidney, or metabolic diseases
- Inadequate wash-out period from prior anti-tumor treatments before apheresis
- Previous treatment with CAR-T cells, genetically modified T-cell therapies, or BCMA-targeted therapies
- Any condition, therapy, or lab abnormality that may interfere with study results or patient safety in the investigator's opinion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
Research Team
Y
Yan Xu, M.D., PH.D.
CONTACT
D
Dehui Zou, M.D., PH.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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