A Study of C-CAR088 in Patients With Relapsed or Refractory Multiple Myeloma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05521802
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Cellular Biomedicine Group Ltd.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Lugui Qiu
Principal Investigator Affiliation Institute of Hematology and Blood Diseases Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Myeloma
Additional Details

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.

Arms & Interventions

Arms

Experimental: C-CAR088

Autologous C-CAR088 administered by intravenous (IV) infusion

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Tianjin, China

Status

Recruiting

Address

Institute of Hematology and Blood Diseases Hospital

Tianjin, ,

Site Contact

Lugui Qiu, M.D., Ph.D.

Qiulg@ihcams.ac.cn

022-23909083