NCT05521802

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P75+ for phase_1 multiple-myeloma

Timeline
136mo left

Started Nov 2022

Longer than P75 for phase_1 multiple-myeloma

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress24%
Nov 2022Jul 2037

First Submitted

Initial submission to the registry

August 28, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 30, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

November 11, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
13 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2037

Expected
Last Updated

March 24, 2023

Status Verified

March 1, 2023

Enrollment Period

1.6 years

First QC Date

August 28, 2022

Last Update Submit

March 22, 2023

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (2)

  • [phase Ib] Incidence and severity of Adverse Events

    Incidence and severity of Adverse Events

    24 months

  • [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 Outcomes (16)

  • Overall response rate (ORR)

    24 months

  • [phase Ib] Overall response rate (ORR) at 3 months after C-CAR088 infusion

    3 months

  • Duration of response (DOR)

    24 months

  • Time to response (TTR)

    24 months

  • Progression-free survival (PFS)

    24 months

  • +11 more secondary outcomes

Study Arms (1)

C-CAR088

EXPERIMENTAL

Autologous C-CAR088 administered by intravenous (IV) infusion

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

Interventions

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

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

C-CAR088

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Hematology and Blood Diseases Hospital

Tianjin, China

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

B-Cell Maturation Antigenbis(3-bis(4-chlorophenyl)methyl-4-dimethylaminophenyl)amineImmunotherapy, Adoptive

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Receptors, Tumor Necrosis FactorReceptors, CytokineReceptors, ImmunologicReceptors, Cell SurfaceMembrane ProteinsProteinsAmino Acids, Peptides, and ProteinsAdoptive TransferImmunization, PassiveImmunizationImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative Techniques

Study Officials

  • Lugui Qiu

    Institute of Hematology & Blood Diseases Hospital, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

022-23909083Qiulg@ihcams.ac.cn

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

CONTACT

022-23909171angang@ihcams.ac.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2022

First Posted

August 30, 2022

Study Start

November 11, 2022

Primary Completion

July 1, 2024

Study Completion (Estimated)

July 1, 2037

Last Updated

March 24, 2023

Record last verified: 2023-03

Locations

CN(1)