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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05521802
• Other study ID #: 0203-029
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: November 11, 2022
• Est. completion date: July 2037

Study information

• Verified date: March 2023
• Source: Cellular Biomedicine Group Ltd.
• Contact: Lugui Qiu, M.D., PH.D.
• Phone: 022-23909083
• Email: Qiulg[@]ihcams.ac.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. completion date: July 2037
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ?/? 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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Biological:
• B-cell maturation antigen (BCMA) directed chimeric antigen receptor (CAR)-T cell
Autologous 2nd generation BCMA-directed CAR-T cells, single infusion intravenously

Locations

Country	Name	City	State
China	Institute of Hematology and Blood Diseases Hospital	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Cellular Biomedicine Group Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	[phase Ib] Incidence and severity of Adverse Events	Incidence and severity of Adverse Events	24 months
Primary	[phase II] Overall response rate (ORR) at 3 months after C-CAR088 infusion	the rate of patients with best response of partial response (PR) or better at 3 months after C-CAR088 infusion	3 months
Secondary	Overall response rate (ORR)	The rate of patients with best response of partial response (PR) or better	24 months
Secondary	[phase Ib] Overall response rate (ORR) at 3 months after C-CAR088 infusion	The rate of patients with best response of partial response (PR) or better at 3 months after C-CAR088 infusion	3 months
Secondary	Duration of response (DOR)	The time from the first documented PR or better response to relapse or death, whichever occurs first	24 months
Secondary	Time to response (TTR)	The time from the date of C-CAR088 infusion to the first documented PR or better	24 months
Secondary	Progression-free survival (PFS)	The time from the date of C-CAR088 infusion to the date of first documented disease progression or death	24 months
Secondary	Overall survival (OS)	The time from the date of C-CAR088 infusion to the date of death	24 months
Secondary	Minimal residual disease (MRD) negativity rate	The rate of patients reached MRD negativity	24 months
Secondary	[phase II] Incidence and severity of Adverse Events	Incidence and severity of Adverse Events	24 months
Secondary	Maximal plasma concentration (Cmax)	maximal plasma concentration of C-CAR088 in peripheral blood	24 months
Secondary	Time to reach the maximal plasma concentration (Tmax)	Time to reach the maximal plasma concentration of C-CAR088 in peripheral blood	24 months
Secondary	Area under the curve within 28 days (AUC0-28d)	Area under the curve of C-CAR088 in peripheral blood within 28 days post infusion	28 days
Secondary	Time of last measurable observed concentration (Tlast)	Time of last measurable observed concentration of C-CAR088 in peripheral blood	24 months
Secondary	Anti-drug (C-CAR088) antibody	Presence of serum anti-drug (C-CAR088) antibody	24 months
Secondary	Serum M protein	serum M proteins concentration changes over time	24 months
Secondary	Urine M protein	Urine M proteins concentration changes over time	24 months
Secondary	Serum free light chain (sFLC)	Serum free light chain (sFLC) concentration changes over time	24 months