Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-25 @ 4:03 AM
NCT ID:
NCT05521802
Eligibility Criteria:
Inclusion Criteria
* ≥ 18 years of age, male or female patients
* Relapsed or refractory multiple myeloma
* Have been treated with ≥ 3 prior lines of therapy, including at least one proteasome inhibitor and one immunomodulatory drug, and had progressed during or within 12 months post the last treatment.
* Had measurable disease as defined by any of the following criteria:
* Serum M protein ≥ 0.5g/dL
* Urine M protein ≥ 200mg/24h
* Serum free light chain (sFLC): abnormal κ/λ ratio with involved sFLC ≥ 100mg/L
* Adequate liver, renal, bone marrow, and heart function
* Eastern cooperative oncology group (ECOG) 0-1
Exclusion Criteria
* Any known allergies to the components or excipients of the C-CAR088 cell product
* Prior allogeneic hematopoietic stem cell transplantation (HSCT) at anytime, or autologous stem-cell transplantation (ASCT) within 12 weeks prior to apheresis
* Central nervous system (CNS) involvement
* Stroke or convulsion history within 6 months prior to signing informed consent form (ICF)
* Plasma leukemia
* Autoimmune disease, immunodeficiency or diseases requiring immunosuppressants treatment
* Uncontrolled active infection; active hepatitis B virus (HBV), hepatitis C virus (HCV) infection; HIV or syphilis infection
* Severe heart, liver, renal or metabolism disease
* Inadequate wash-out time for previous anti-tumor treatments prior to apheresis
* Previous CAR-T cell treatment, genetically modified T-cell therapies or BCMA-directed treatment history
* History or current evidence of any condition, therapy, or laboratory abnormality that, in the opinion of the investigator, might confound the results of the trial, interfere with the patient's safe participation and compliance in the trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05521802
Study Brief:
Protocol Section:
NCT05521802