Evaluating C-CAR088 for patients with relapsed or refractory multiple myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.