A Study of C-CAR088 in Patients With Relapsed or Refractory Multiple Myeloma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: B-cell maturation antigen (BCMA) directed chimeric antigen receptor (CAR)-T cell.
- Who it may be relevant to
- Registry conditions: Multiple Myeloma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase Ib/II Study of CBM.BCMA Chimeric Antigen Receptor T Cell Product (C-CAR088) for Treating Patients With Relapsed or Refractory Multiple Myeloma
Overview
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.
Detailed description
The study includes the following sequential procedures: Screening, Apheresis and C-CAR088 manufacturing, Baseline testing, Lymphodepletion, C-CAR088 infusion, and Follow-up Visit. Two dose levels of C-CAR088 will be tested during the phase Ib part to determine RP2D, which will be further evaluated during the phase II part.
Interventions
- Biological B-cell maturation antigen (BCMA) directed chimeric antigen receptor (CAR)-T cell
Autologous 2nd generation BCMA-directed CAR-T cells, single infusion intravenously
Primary outcome measures
- [phase Ib] Incidence and severity of Adverse Events [Time frame: 24 months]
- [phase II] Overall response rate (ORR) at 3 months after C-CAR088 infusion [Time frame: 3 months]
Secondary outcome measures (12)
- Overall response rate (ORR) [Time frame: 24 months]
- [phase Ib] Overall response rate (ORR) at 3 months after C-CAR088 infusion [Time frame: 3 months]
- Duration of response (DOR) [Time frame: 24 months]
- Time to response (TTR) [Time frame: 24 months]
- Progression-free survival (PFS) [Time frame: 24 months]
- Overall survival (OS) [Time frame: 24 months]
- Minimal residual disease (MRD) negativity rate [Time frame: 24 months]
- [phase II] Incidence and severity of Adverse Events [Time frame: 24 months]
- Maximal plasma concentration (Cmax) [Time frame: 24 months]
- Time to reach the maximal plasma concentration (Tmax) [Time frame: 24 months]
- Area under the curve within 28 days (AUC0-28d) [Time frame: 28 days]
- Time of last measurable observed concentration (Tlast) [Time frame: 24 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Institute of Hematology and Blood Diseases Hospital — Tianjin
Identifiers
NCT: NCT05521802 · 0203-029