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

Cellular Biomedicine Group

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Multiple Myeloma

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05521802

0203-029

Details and patient eligibility

About

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.

Full 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.

Enrollment: 92 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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 design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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92 participants in 1 patient group

C-CAR088

Experimental group

Description:

Autologous C-CAR088 administered by intravenous (IV) infusion

Treatment:

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