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Trial Title:
ASCT in Combination With C-CAR088 for Treating Patients With Ultra High-risk Multiple Myeloma (MM)
NCT ID:
NCT05632380
Condition:
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Autologous hematopoietic stem cell transplantation
Description:
Patients receive transplantation conditioning followed by autologous hematopoietic stem
cell transplantation after successful stem cell mobilization and collection. If
previously collected stem cells are available, no stem cell mobilization or collection is
required, and patients will receive conditioning directly.
Arm group label:
ASCT and C-CAR088
Intervention type:
Biological
Intervention name:
C-CAR088
Description:
C-CAR088 is an BCMA targeted Chimeric Antigen Receptor-T cell product. Patients will
receive C-CAR088 single dose infusion 3 days after ASCT. The dose level of C-CAR088 will
be determined by the investigator.
Arm group label:
ASCT and C-CAR088
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.
Detailed description:
Patients with ultra high-risk multiple myeloma will undergo leukapheresis, stem cell
mobilization and collection (could omit if collected before screening), conditioning,
ASCT and C-CAR088 infusion. Patients receive a single dose of C-CAR088 three days
post-ASCT. Two conditioning protocols and two dose levels of C-CAR088 will be used based
on the investigator's discretion. Patients will be evaluated closely for safety of
efficacy during the first three months, then less frequently in the following months
until 24 months post-ASCT.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Institute of Hematology & Blood Diseases Hospital
Address:
City:
Tianjin
Zip:
300020
Country:
China
Status:
Recruiting
Contact:
Last name:
Dehui Zou, M.D., Ph.D.
Phone:
86-022-23909282
Email:
zoudehui@ihcams.ac.cn
Start date:
July 14, 2022
Completion date:
June 30, 2025
Lead sponsor:
Agency:
Institute of Hematology & Blood Diseases Hospital, China
Agency class:
Other
Collaborator:
Agency:
Shanghai AbelZeta Ltd.
Agency class:
Industry
Source:
Institute of Hematology & Blood Diseases Hospital, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05632380
