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

NCT ID: NCT05521802

Last Updated: 2023-03-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-11
• Study Completion Date: 2037-07-31

Brief 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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

C-CAR088

Autologous C-CAR088 administered by intravenous (IV) infusion

Group Type: EXPERIMENTAL

B-cell maturation antigen (BCMA) directed chimeric antigen receptor (CAR)-T cell

Intervention Type: BIOLOGICAL

Autologous 2nd generation BCMA-directed CAR-T cells, single infusion intravenously

Interventions

B-cell maturation antigen (BCMA) directed chimeric antigen receptor (CAR)-T cell

Autologous 2nd generation BCMA-directed CAR-T cells, single infusion intravenously

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai AbelZeta Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lugui Qiu

Role: PRINCIPAL_INVESTIGATOR

Institute of Hematology & Blood Diseases Hospital, China

Locations

Institute of Hematology and Blood Diseases Hospital

Tianjin, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Lugui Qiu, M.D., PH.D.

Role: CONTACT

Qiulg@ihcams.ac.cn

022-23909083

An Gang, M.D., PH.D.

Role: CONTACT

angang@ihcams.ac.cn

022-23909171

Facility Contacts

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

Role: primary

Qiulg@ihcams.ac.cn

022-23909083

Other Identifiers

0203-029

Identifier Type: -

Identifier Source: org_study_id