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New treatment option for Multiple Myeloma
Official title ASCT in Combination With C-CAR088 for Treating Patients With Ultra High-risk Multiple Myeloma (MM)
ClinicalTrials.gov ID: NCT05632380
What this study is testing
What is C-CAR088?
C-CAR088 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for multiple myeloma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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
See the full eligibility 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.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.