Using stem cell transplantation with C-CAR088 to treat ultra high-risk multiple myeloma
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
This study is testing a new treatment combining stem cell transplantation and a special CAR-T cell therapy to see if it can help people with ultra high-risk multiple myeloma who haven't responded well to other treatments.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China Academic / other |
| Drugs / interventions | CAR-T |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Trial ID | NCT05632380 on ClinicalTrials.gov |
What this trial studies
This phase I/II clinical trial investigates the combination of autologous stem cell transplantation (ASCT) and C-CAR088, an autologous BCMA CAR-T cell therapy, for patients with ultra high-risk multiple myeloma. Participants will undergo leukapheresis, stem cell collection, conditioning, and receive a single dose of C-CAR088 three days after ASCT. The study will evaluate the safety and efficacy of this treatment approach over a period of 24 months, with close monitoring during the initial three months. The trial aims to provide a new therapeutic option for patients who have not responded adequately to standard treatments.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 18 to 65 with ultra high-risk multiple myeloma who have not responded to front line VRD-based treatment.
Not a fit: Patients with prior allogenic or autologous stem cell transplants, CNS involvement, or severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve outcomes for patients with ultra high-risk multiple myeloma who have limited treatment options.
How similar studies have performed: While the combination of ASCT and CAR-T therapies is a novel approach, similar studies have shown promise in treating other hematological malignancies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. 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
Where this trial is running
Tianjin, Tianjin Municipality
- Institute of Hematology & Blood Diseases Hospital — Tianjin, Tianjin Municipality, China (Recruiting)
Study contacts
- Principal investigator: Dehui Zou, M.D., PH.D. — Institute of Hematology & Blood Diseases Hospital, China
- Study coordinator: Yan Xu, M.D., PH.D.
- Email: xuyan1@ihcams.ac.cn
- Phone: 86-022-23909171
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.