NCT05632380RecruitingPhase 1/2
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 · Last updated 7 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 8 Nov 2022
- Start date
- 14 Jul 2022
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Diseases
- Multiple myeloma
- NCT number
- NCT05632380
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 20
- From 14 Jul 2022 to the primary completion date, 30 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior allogenic HSCT, or ASCT
- Stroke or convulsion history within 6 months prior to signing ICF
- 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
Other illness
- Known allergies to the components or excipients of the C-CAR088 cell product
- 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
Lab values
- 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
Other
- CNS involvement
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institute of Hematology & Blood Diseases Hospital Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.