Evaluating C-CAR088 for 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
This study is testing a new CAR-T cell therapy called C-CAR088 to see if it can help people with relapsed or refractory multiple myeloma feel better.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 92 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shanghai AbelZeta Ltd. Industry-sponsored |
| Drugs / interventions | CAR-T |
| Locations | 1 site (Tianjin) |
| Trial ID | NCT05521802 on ClinicalTrials.gov |
What this trial studies
This multicenter, open-label study aims to assess the safety and efficacy of C-CAR088, a B-cell maturation antigen (BCMA) directed CAR-T cell therapy, in patients suffering from relapsed or refractory multiple myeloma. The study consists of two phases: the phase Ib part focuses on determining the recommended phase 2 dose (RP2D) of C-CAR088, while the phase II part will further evaluate its efficacy at the established dose. Participants will undergo a series of procedures including screening, apheresis for CAR-T cell manufacturing, lymphodepletion, and infusion of the CAR-T cells, followed by follow-up visits to monitor outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with relapsed or refractory multiple myeloma who have received at least three prior lines of therapy.
Not a fit: Patients with central nervous system involvement or those who have had recent stem cell transplants may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat multiple myeloma.
How similar studies have performed: Other studies using CAR-T cell therapies targeting BCMA have shown promising results, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tianjin
- Institute of Hematology and Blood Diseases Hospital — Tianjin, China (Recruiting)
Study contacts
- Principal investigator: Lugui Qiu — Institute of Hematology & Blood Diseases Hospital, China
- Study coordinator: Lugui Qiu, M.D., PH.D.
- Email: Qiulg@ihcams.ac.cn
- Phone: 022-23909083
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.