Actively Recruiting
A Study of C-CAR088 in Patients With Relapsed or Refractory Multiple Myeloma
Led by Shanghai AbelZeta Ltd. · Updated on 2023-03-24
92
Participants Needed
1
Research Sites
763 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of C-CAR088 in Patients With Relapsed or Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older, male or female
- Diagnosed with relapsed or refractory multiple myeloma
- Previously treated with at least 3 lines of therapy, including at least one proteasome inhibitor and one immunomodulatory drug
- Disease progression during or within 12 months after last treatment
- Measurable disease by serum M protein 60.5 g/dL, or urine M protein 60200 mg/24h, or abnormal serum free light chain ratio with involved sFLC 60100 mg/L
- Adequate liver, kidney, bone marrow, and heart function
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
You will not qualify if you...
- Known allergies to components or excipients of the C-CAR088 cell product
- Prior allogeneic hematopoietic stem cell transplantation at any time
- Autologous stem-cell transplantation within 12 weeks prior to apheresis
- Central nervous system involvement
- History of stroke or convulsion within 6 months before informed consent
- Plasma leukemia
- Autoimmune disease, immunodeficiency, or requiring immunosuppressant treatment
- Uncontrolled active infection including hepatitis B, hepatitis C, HIV, or syphilis
- Severe heart, liver, kidney, or metabolic disease
- Inadequate wash-out time from previous anti-tumor treatments before apheresis
- Previous CAR-T cell treatment, genetically modified T-cell therapies, or BCMA-directed therapy
- Any condition or therapy that might interfere with safe participation or study results as judged by the investigator
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 and Blood Diseases Hospital
Tianjin, China
Actively Recruiting
Research Team
L
Lugui Qiu, M.D., PH.D.
CONTACT
A
An Gang, 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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