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Trial Title:
A Study of C-CAR088 in Patients With Relapsed or Refractory Multiple Myeloma
NCT ID:
NCT05521802
Condition:
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
B-cell maturation antigen (BCMA) directed chimeric antigen receptor (CAR)-T cell
Description:
Autologous 2nd generation BCMA-directed CAR-T cells, single infusion intravenously
Arm group label:
C-CAR088
Summary:
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Institute of Hematology and Blood Diseases Hospital
Address:
City:
Tianjin
Country:
China
Status:
Recruiting
Contact:
Last name:
Lugui Qiu, M.D., Ph.D.
Phone:
022-23909083
Email:
Qiulg@ihcams.ac.cn
Start date:
November 11, 2022
Completion date:
July 2037
Lead sponsor:
Agency:
Shanghai AbelZeta Ltd.
Agency class:
Industry
Source:
Shanghai AbelZeta Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05521802