Multiple MyelomaPhase 1/2NCT05632380
ASCT in Combination With C-CAR088 for Treating Patients With Ultra High-risk Multiple Myeloma (MM)
A Phase 1/2 study testing Autologous hematopoietic stem cell transplantation and C-CAR088 in people with Multiple Myeloma, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Autologous hematopoietic stem cell transplantation and C-CAR088
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 14 Jul 2022to 30 Oct 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dehui Zou, M.D., PH.D. contact
China1 site, 1 recruiting
- Recruiting
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, 300020
Dehui Zou, M.D., Ph.D., 86-022-23909282, zoudehui@ihcams.ac.cn
About this study
Official title: 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 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.
Read the 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.
- Conditions
- Multiple Myeloma
- Being tested
- Autologous hematopoietic stem cell transplantation, C-CAR088
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous hematopoietic stem cell transplantationProcedure or surgery
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.
C-CAR088Biological
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.
| Study group | Role | What they receive |
|---|---|---|
| ASCT and C-CAR088 | Experimental | Patients will undergo ASCT followed by C-CAR088 single dose infusion. Receives: Procedure: Autologous hematopoietic stem cell transplantation; Biological: C-CAR088 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate and severity of adverse events (AE)
Incidence rate and severity of adverse events (AE)
Measured: 24 months
Secondary outcomes (10)
Progression free survival (PFS)
The time from the initiation of study treatment to the date of first documented disease progression or death
Measured: 24 months
MRD negativity rate
The percentage of patients who reached MRD negativity
Measured: 24 months
Overall response rate (ORR)
The percentage of patients who reached PR, VGPR, CR or sCR as their best response
Measured: 24 months
Duration of response (DOR)
The time from the first documented PR or better response to progression or death, whichever occurs first
Measured: 24 months
Time to response (TTR)
The time between the initiation of study treatment until the the first documented PR or better response
Measured: 24 months
Overall Survival (OS)
OS is defined as the time from the initiation of study treatment to death from any cause
Measured: 24 months
Cmax (maximal plasma concentration)
Maximal plasma concentration of C-CAR088 in peripheral blood
Measured: 24 months
Tmax (Time to reach the maximal plasma conceration)
Time to reach the maximal plasma conceration of C-CAR088 in peripheral blood
Measured: 24 months
AUC0-28d (area under the curve from day 0-day 28)
Area under the curve of C-CAR088 in peripheral blood within 28 days post C-CAR088 infusion
Measured: 28 days post C-CAR088 infusion
Tlast (Time of last measurable observed concentration)
Time of last measurable observed concentration of C-CAR088 in peripheral blood
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start14 Jul 2022
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai AbelZeta Ltd.
- Responsible party
- Sponsor
- Investigators
- Dehui Zou, M.D., PH.D., Principal investigator, Institute of Hematology & Blood Diseases Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05632380
- Sponsor's protocol ID
- IIT2022012
- Status last verified
- Sep 2025
- First submitted
- 8 Nov 2022
- Last updated
- 7 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05632380
- Acronym / sponsor ID
- IIT2022012
- Conditions
- Multiple Myeloma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Collaborators
- Shanghai AbelZeta Ltd.
- Study start
- 14 Jul 2022 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 30 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ASCT and C-CAR088 | Experimental | Procedure: Autologous hematopoietic stem cell transplantation, Biological: C-CAR088Patients will undergo ASCT followed by C-CAR088 single dose infusion. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous hematopoietic stem cell transplantationPatients 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. | Procedure or surgery | ASCT and C-CAR088 |
| C-CAR088C-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. | Biological | ASCT and C-CAR088 |
Primary outcome
Incidence rate and severity of adverse events (AE)
Time frame: 24 months
Incidence rate and severity of adverse events (AE)
10 secondary outcomes
Progression free survival (PFS)
Time frame: 24 months
MRD negativity rate
Time frame: 24 months
Overall response rate (ORR)
Time frame: 24 months
Duration of response (DOR)
Time frame: 24 months
Time to response (TTR)
Time frame: 24 months
Overall Survival (OS)
Time frame: 24 months
Cmax (maximal plasma concentration)
Time frame: 24 months
Tmax (Time to reach the maximal plasma conceration)
Time frame: 24 months
AUC0-28d (area under the curve from day 0-day 28)
Time frame: 28 days post C-CAR088 infusion
Tlast (Time of last measurable observed concentration)
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dehui Zou, M.D., PH.D. contact
Dehui Zou, M.D., PH.D. principal investigator
Institute of Hematology & Blood Diseases Hospital, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Autologous hematopoietic stem cell transplantation and C-CAR088 in people with Multiple Myeloma, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yan Xu, M.D., PH.D. (86-022-23909171, xuyan1@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate and severity of adverse events (AE) (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.