NCT05521802RecruitingPhase 1/2
A Study of C-CAR088 in Patients With Relapsed or Refractory Multiple Myeloma
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
Source: ClinicalTrials.gov · Last updated 24 Mar 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 92 (estimated)
- First submitted
- 28 Aug 2022
- Start date
- 11 Nov 2022
- Primary completion date
- Jul 2024
- Lead sponsor
- Shanghai AbelZeta Ltd.
- Diseases
- Multiple myeloma
- NCT number
- NCT05521802
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 92
- From 11 Nov 2022 to the primary completion date, Jul 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior allogeneic hematopoietic stem cell transplantation (HSCT) at anytime, or autologous stem-cell transplantation (ASCT) within 12 weeks prior to apheresis
- Stroke or convulsion history within 6 months prior to signing informed consent form (ICF)
- 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
Other illness
- Any known allergies to the components or excipients of the C-CAR088 cell product
- 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
Lab values
- 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
Other
- Central nervous system (CNS) involvement
- Plasma leukemia
Who the study is looking for
- ≥ 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institute of Hematology and Blood Diseases Hospital Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.