Clinical trial · Interventional
ASCT in Combination With C-CAR088 for Treating Patients With Ultra High-risk Multiple Myeloma (MM)
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous hematopoietic stem cell transplantation | Procedure | — | UNRESOLVED |
| C-CAR088 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ASCT and C-CAR088
- description
- Patients will undergo ASCT followed by C-CAR088 single dose infusion.
- interventionNames
- Procedure: Autologous hematopoietic stem cell transplantation
- Biological: C-CAR088
Primary outcomes (1)
- measure
- Incidence rate and severity of adverse events (AE)
- timeFrame
- 24 months
- description
- Incidence rate and severity of adverse events (AE)
Secondary outcomes (10)
- measure
- Progression free survival (PFS)
- timeFrame
- 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available