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Recruiting NCT05632380

ASCT in Combination With C-CAR088 for Treating Patients With Ultra High-risk Multiple Myeloma (MM)

Phase I / Phase II Interventional Multiple Myeloma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Autologous hematopoietic stem cell transplantation, C-CAR088.
Who it may be relevant to
Registry conditions: Multiple Myeloma. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Safety and Efficacy of Autologous Hematopoietic Stem Cell Transplantation (ASCT) in Combination With C-CAR088, an Autologous BCMA CAR-T Cell Product, for Treating Patients With Ultra High-risk Multiple Myeloma

Overview

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.

Detailed description

Patients with ultra high-risk multiple myeloma will undergo leukapheresis, stem cell mobilization and collection (could omit if collected before screening), conditioning, ASCT and C-CAR088 infusion. Patients receive a single dose of C-CAR088 three days post-ASCT. Two conditioning protocols and two dose levels of C-CAR088 will be used based on the investigator's discretion. Patients will be evaluated closely for safety of efficacy during the first three months, then less frequently in the following months until 24 months post-ASCT.

Interventions

  • Procedure Autologous hematopoietic stem cell transplantation
    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.
  • Biological C-CAR088
    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.

Primary outcome measures

  • Incidence rate and severity of adverse events (AE) [Time frame: 24 months]
Secondary outcome measures (10)
  • Progression free survival (PFS) [Time frame: 24 months]
  • MRD negativity rate [Time frame: 24 months]
  • Overall response rate (ORR) [Time frame: 24 months]
  • Duration of response (DOR) [Time frame: 24 months]
  • Time to response (TTR) [Time frame: 24 months]
  • Overall Survival (OS) [Time frame: 24 months]
  • Cmax (maximal plasma concentration) [Time frame: 24 months]
  • Tmax (Time to reach the maximal plasma conceration) [Time frame: 24 months]
  • AUC0-28d (area under the curve from day 0-day 28) [Time frame: 28 days post C-CAR088 infusion]
  • Tlast (Time of last measurable observed concentration) [Time frame: 24 months]

Eligibility criteria

Inclusion criteria

  • Transplantation eligible patients, male or female, aged 18 to 70 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.

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Institute of Hematology & Blood Diseases Hospital — Tianjin

Identifiers

NCT: NCT05632380 · IIT2022012

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗