NCT05632380

Brief Summary

This is a phase I/II, single-arm, open-lable study of autologous stem cell transplantation in combination with C-CAR088, an autologous BCMA CAR-T cell product, for patients with ulta high-risk multiple myeloma, defined as failed or unsatisfied responses to front line VRD-based treatment with or without the presence of multiple high-risk cytogenetic features.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1 multiple-myeloma

Timeline
Completed

Started Jul 2022

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 Start

First participant enrolled

July 14, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

November 30, 2022

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

October 1, 2025

Status Verified

September 1, 2025

Enrollment Period

3.3 years

First QC Date

November 8, 2022

Last Update Submit

September 25, 2025

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

  • Incidence rate and severity of adverse events (AE)

    Incidence rate and severity of adverse events (AE)

    24 months

Secondary Outcomes (10)

  • Progression free survival (PFS)

    24 months

  • MRD negativity rate

    24 months

  • Overall response rate (ORR)

    24 months

  • Duration of response (DOR)

    24 months

  • Time to response (TTR)

    24 months

  • +5 more secondary outcomes

Other Outcomes (1)

  • Anti-drug (C-CAR088) antibody

    24 months

Study Arms (1)

ASCT and C-CAR088

EXPERIMENTAL

Patients will undergo ASCT followed by C-CAR088 single dose infusion.

Procedure: Autologous hematopoietic stem cell transplantationBiological: C-CAR088

Interventions

Autologous hematopoietic stem cell transplantationPROCEDURE

Patients receive transplantation conditioning followed by autologous hematopoietic stem cell transplantation after successful stem cell mobilization and collection. If previously collected stem cells are available, no stem cell mobilization or collection is required, and patients will receive conditioning directly.

ASCT and C-CAR088
C-CAR088BIOLOGICAL

C-CAR088 is an BCMA targeted Chimeric Antigen Receptor-T cell product. Patients will receive C-CAR088 single dose infusion 3 days after ASCT. The dose level of C-CAR088 will be determined by the investigator.

ASCT and C-CAR088

Eligibility Criteria

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

You may qualify if:

  • Transplantation eligible patients, male or female, aged 18 to 65 years
  • Ultra high risk multiple myeloma, defined as failed or unsatisfied responses to front line VRD-based treatment with or without the presence of multiple high-risk cytogenetic features
  • Adequate liver, renal, bone marrow, and heart function
  • Eastern Cooperative Oncology Group (ECOG) Performance status 0-1.
  • Male and female of reproductive potential must agree to use birth control during the study.

You may not qualify if:

  • Known allergies to the components or excipients of the C-CAR088 cell product
  • Prior allogenic HSCT, or ASCT
  • CNS involvement
  • Stroke or convulsion history within 6 months prior to signing ICF
  • Autoimmune disease, immunodeficiency or disease requiring immunosuppressants treatment
  • Uncontrolled active infection; active HBV, 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 & Blood Diseases Hospital

Tianjin, Tianjin Municipality, 300020, China

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

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

Study Officials

  • Dehui Zou, M.D., PH.D.

    Institute of Hematology & Blood Diseases Hospital, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Xu, M.D., PH.D.

CONTACT

86-022-23909171xuyan1@ihcams.ac.cn

Dehui Zou, M.D., PH.D.

CONTACT

Study Design

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

Study Record Dates

First Submitted

November 8, 2022

First Posted

November 30, 2022

Study Start

July 14, 2022

Primary Completion

October 30, 2025

Study Completion

April 30, 2026

Last Updated

October 1, 2025

Record last verified: 2025-09

Locations

CN(1)