NCT05632380 ASCT in Combination With C-CAR088 for Treating Patients With Ultra High-risk Multiple Myeloma (MM)
| NCT ID | NCT05632380 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China |
| Condition | Multiple Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2022-07-14 |
| Primary Completion | 2025-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2022-07-14 with a primary completion date of 2025-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Dehui Zou, M.D., PH.D.
PRINCIPAL INVESTIGATOR
Institute of Hematology & Blood Diseases Hospital, China
Frequently Asked Questions
Who can join the NCT05632380 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Multiple Myeloma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05632380 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05632380 currently recruiting?
Yes, NCT05632380 is actively recruiting participants. Contact the research team at xuyan1@ihcams.ac.cn for enrollment information.
Where is the NCT05632380 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT05632380 clinical trial?
NCT05632380 is sponsored by Institute of Hematology & Blood Diseases Hospital, China. The principal investigator is Dehui Zou, M.D., PH.D. at Institute of Hematology & Blood Diseases Hospital, China. The trial plans to enroll 20 participants.