Multiple MyelomaPhase 1NCT07620275
Safety and Efficacy of KSVCBD Injection in Multiple Myeloma Expressing CD19 and/or BCMA
A Phase 1 study testing KSVCBD injection in people with Multiple Myeloma, run by Chinese PLA General Hospital at 3 sites in China.
Trial summary
KSVCBD injection is an in vivo Chimeric Antigen Receptor T-Cell (CAR-T cell) therapy product. This multicenter, single-arm, open-label, early exploratory clinical study is designed to evaluate the preliminary safety and efficacy of KSVCBD injection in patients with relapsed or refractory (r/r) multiple myeloma(MM)… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- KSVCBD injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 3 sitesChina
- Study dates
- 3 Sep 2026to 15 Mar 2029
- Phase
- Phase 1
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years (inclusive), any gender.
- Subjects must meet the following diagnostic and treatment criteria:
- 2.1 According to the IMWG 2014 diagnostic criteria, subjects must have a confirmed diagnosis of multiple myeloma and be in a relapsed or refractory state at screening, while meeting all of the following conditions:
- Must have received at least 3 prior lines of MM therapy (including a proteasome inhibitor and an immunomodulatory agent). consecutive cycles of induction chemotherapy, hematopoietic stem cell transplantation, and maintenance therapy are considered as one line of therapy if no disease progression occurs between these treatments. each line of therapy must consist of at least one complete treatment cycle, unless the best response to that regimen was disease progression.
- Must have experienced disease progression during or within 12 months after the most recent anti-myeloma therapy. or the subject must have experienced disease progression within the last 6 months and subsequently shown no response to the most recent line of therapy. Lack of response is defined as failure to achieve at least a minimal response (MR) or experiencing disease progression (PD) during treatment.
- 2.2 Subjects judged by the investigator to be intolerant to standard therapy may also be included in the study.
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- Presence of measurable lesions at screening as determined by any of the following criteria:
- Serum monoclonal paraprotein (M-protein) level ≥ 1.0 g/dL, or urinary M-protein level ≥ 200 mg/24 hours. or
- For light chain multiple myeloma without measurable lesions in serum or urine: serum immunoglobulin free light chain level ≥ 10 mg/dL and an abnormal serum immunoglobulin κ/λ free light chain ratio.
- Positive expression of CD19 and/or BCMA in tumor tissue confirmed by flow cytometry and/or histopathology (previous pathology or flow cytometry diagnosis of CD19 and/or BCMA in the patient, as confirmed by the investigator, is acceptable). For subjects who have previously received anti-CD19 and/or anti-BCMA therapy, a tumor biopsy should be performed to confirm current positive expression of CD19 and/or BCMA.
- Toxicities from any prior therapy must be stable and have resolved to ≤ Grade 1 (excluding hematologic toxicities and clinically insignificant toxicities such as alopecia).
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
Who cannot join
- Expected survival < 3 months.
- History of or concurrent active malignancy. Exceptions include: carcinoma in situ of the cervix that has been cured or with no recurrence for at least 3 years, non-invasive basal cell or squamous cell skin cancer, locally advanced prostate cancer that has received curative treatment, or ductal carcinoma in situ after radical surgery.
- Prior allogeneic hematopoietic stem cell transplantation (allo-HSCT) or autologous HSCT within 3 months prior to KSVCBD infusion.
- Diagnosis of plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome, or primary AL amyloidosis.
- Presence of CNS metastasis or symptoms of CNS metastasis.
- Receipt of anti-tumor therapy that is still within 5 half-lives prior to the planned KSVCBD infusion.
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- Presence of uncontrolled active infections.
- Positive for human immunodeficiency virus (HIV) antibody, positive for Treponema pallidum antibody, positive for hepatitis B surface antigen (HBsAg) or positive for hepatitis B core antibody (HBcAb) with detectable peripheral blood HBV DNA, or positive for hepatitis C virus (HCV) antibody with detectable HCV RNA. except for infections that the investigator judges can be prevented or controlled with medication.
- Known active autoimmune disease requiring systemic treatment.
- Known severe allergy to the study drug or any of its components.
- Pregnant or breastfeeding women.
- Receipt of a live vaccine within 6 weeks prior to enrollment.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Biotherapeutic Department of Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Weidong Han, M.D., +86-10-66937463, hanwdrsw@sina.com
Yang Liu, M.D.
- Not yet recruiting
Department of Hematology, Beijing Chao-Yang Hospital, Capital Medical University
Beijing
Wen Gao, M.D.
- Not yet recruiting
National Clinical Research Center for Blood Diseases, State Key Laboratory of Experimental Hematology, Blood Diseases Hospital & Institute of Hematology, Chinese Academy of Medical Sciences & Peking Union Medical College
Tianjin
Lugui Qiu, M.D.
Gang An, M.D.
About this study
Official title: A Multicenter Clinical Study on the Safety and Efficacy of KSVCBD Injection in the Treatment of Multiple Myeloma With Positive Expression of CD19 and/or BCMA
KSVCBD injection is an in vivo Chimeric Antigen Receptor T-Cell (CAR-T cell) therapy product. This multicenter, single-arm, open-label, early exploratory clinical study is designed to evaluate the preliminary safety and efficacy of KSVCBD injection in patients with relapsed or refractory (r/r) multiple myeloma(MM) expressing CD19 and/or BCMA.
Read the detailed description
A structurally modified, third-generation, self-inactivating lentiviral vector was used in KSVCBD injection. This modified vector exhibits reduced immunogenicity and enables efficient T-cell targeting, thereby facilitating the in vivo generation of CD19/BCMA CAR T cells from endogenous T cells. Simultaneously targeting BCMA to eliminate plasma cells producing anti-lentivirus and anti-CD19 scFv antibodies enables repeated infusion. The safety and efficacy of CD19/BCMA dual-target autologous CAR-T therapy for the treatment of r/r MM have already been validated in clinical studies. In this study, dose-escalation research will be conducted to explore the safety and preliminary efficacy of CD19/BCMA dual-target in vivo CAR-T therapy in patients with r/r MM who are positive for CD19 and/or BCMA expression.
- Conditions
- Multiple Myeloma
- Being tested
- KSVCBD injection
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KSVCBD injectionBiological
KSVCBD injection is an in vivo CAR-T therapy targeting CD19/BCMA. Three dose levels are predefined, and KSVCBD will be dose-escalated per the protocol-specified doses
| Study group | Role | What they receive |
|---|---|---|
| KSVCBD injection | Experimental | Administered by IV infusion Receives: Biological: KSVCBD injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limited toxicity (DLT)
DLT is defined as any of the following adverse events (AEs) related to KSVCBD infusion occurring within 28 days after KSVCBD infusion
Measured: Within 28 days post-infusion
Incidence and severity of AEs and serious adverse events (SAEs)
AEs refer to any adverse medical events occurring in subjects from the initiation of KSVCBD administration during clinical trials. SAEs denote events involving death, life-threatening conditions, significant disability/incapacity, hospitalization or prolonged hospitalization arising after KSVCBD administration in subjects.
Measured: Within 24 months post-infusion
Incidence and severity of adverse events of special interest (AESI)
AESI including grade ≥ 3 Cytokine Release Syndrome (CRS), Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), and infections
Measured: Within 24 months post-infusion
Secondary outcomes (12)
Objective Response Rate (ORR)
ORR includes Stringent Complete Remission (sCR), CR, Very Good Partial Remission (VGPR), and PR.
Measured: Within 24 months post-infusion
Minimal Residual Disease (MRD) negativity rate
Rate of achieving MRD negativity
Measured: Within 24 months post-infusion
≥ CR rate
Rate of achieving ≥ CR (CR and sCR)
Measured: Within 24 months post-infusion
Duration of Response (DOR)
Time from first documented PR or better to relapse or disease progression, or death from any cause
Measured: Within 24 months post-infusion
Time to Response (TTR)
Time from administration to first documented PR or better.
Measured: Within 24 months post-infusion
Progression-Free Survival (PFS)
Time from administration to disease progression or death from any cause, whichever occurs first.
Measured: Within 24 months post-infusion
Overall Survival (OS)
Time from administration to death from any cause.
Measured: Within 24 months post-infusion
KSVCBD lentiviral particle concentration
KSVCBD lentiviral particle concentration in peripheral blood.
Measured: Within 24 months post-infusion
Number of CAR-positive T cells
Number of CAR-positive T cells in peripheral blood.
Measured: Within 24 months post-infusion
CAR gene copy number
CAR gene copy number in peripheral blood.
Measured: Within 24 months post-infusion
Number of CD19-positive cells
Number of CD19-positive cells in peripheral blood.
Measured: Within 24 months post-infusion
Number of BCMA-positive cells
Number of BCMA-positive cells in peripheral blood.
Measured: Within 24 months post-infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start3 Sep 2026
- Primary completion15 Dec 2028 (estimated)
- Study completion15 Mar 2029 (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 Chinese PLA General HospitalThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han weidong, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07620275
- Sponsor's protocol ID
- KSVCBD-R101-1
- Status last verified
- Sep 2026
- First submitted
- 27 May 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Clinical Study on the Safety and Efficacy of KSVCBD Injection in the Treatment of Multiple Myeloma With Positive Expression of CD19 and/or BCMA
- ClinicalTrials.gov ID
- NCT07620275
- Acronym / sponsor ID
- KSVCBD-R101-1
- Conditions
- Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 3 Sep 2026 (actual)
- Primary completion
- 15 Dec 2028 (estimated)
- Study completion
- 15 Mar 2029 (estimated)
- First posted
- 2 Jun 2026 (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.
KSVCBD injection is an in vivo Chimeric Antigen Receptor T-Cell (CAR-T cell) therapy product. This multicenter, single-arm, open-label, early exploratory clinical study is designed to evaluate the preliminary safety and efficacy of KSVCBD injection in patients with relapsed or refractory (r/r) multiple myeloma(MM) expressing CD19 and/or BCMA.
Detailed description
A structurally modified, third-generation, self-inactivating lentiviral vector was used in KSVCBD injection. This modified vector exhibits reduced immunogenicity and enables efficient T-cell targeting, thereby facilitating the in vivo generation of CD19/BCMA CAR T cells from endogenous T cells. Simultaneously targeting BCMA to eliminate plasma cells producing anti-lentivirus and anti-CD19 scFv antibodies enables repeated infusion. The safety and efficacy of CD19/BCMA dual-target autologous CAR-T therapy for the treatment of r/r MM have already been validated in clinical studies. In this study, dose-escalation research will be conducted to explore the safety and preliminary efficacy of CD19/BCMA dual-target in vivo CAR-T therapy in patients with r/r MM who are positive for CD19 and/or BCMA expression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KSVCBD injection | Experimental | Biological: KSVCBD injectionAdministered by IV infusion |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age 18-75 years (inclusive), any gender.
- Subjects must meet the following diagnostic and treatment criteria:
- 2.1 According to the IMWG 2014 diagnostic criteria, subjects must have a confirmed diagnosis of multiple myeloma and be in a relapsed or refractory state at screening, while meeting all of the following conditions:
- 2.2 Subjects judged by the investigator to be intolerant to standard therapy may also be included in the study.
- Presence of measurable lesions at screening as determined by any of the following criteria:
Key exclusion criteria (12 listed)
- Expected survival < 3 months.
- History of or concurrent active malignancy. Exceptions include: carcinoma in situ of the cervix that has been cured or with no recurrence for at least 3 years, non-invasive basal cell or squamous cell skin cancer, locally advanced prostate cancer that has received curative treatment, or ductal carcinoma in situ after radical surgery.
- Prior allogeneic hematopoietic stem cell transplantation (allo-HSCT) or autologous HSCT within 3 months prior to KSVCBD infusion.
- Diagnosis of plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome, or primary AL amyloidosis.
- Presence of CNS metastasis or symptoms of CNS metastasis.
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 |
|---|---|---|
| KSVCBD injectionKSVCBD injection is an in vivo CAR-T therapy targeting CD19/BCMA. Three dose levels are predefined, and KSVCBD will be dose-escalated per the protocol-specified doses | Biological | KSVCBD injection |
Primary outcome
Dose limited toxicity (DLT)
Time frame: Within 28 days post-infusion
DLT is defined as any of the following adverse events (AEs) related to KSVCBD infusion occurring within 28 days after KSVCBD infusion
Incidence and severity of AEs and serious adverse events (SAEs)
Time frame: Within 24 months post-infusion
AEs refer to any adverse medical events occurring in subjects from the initiation of KSVCBD administration during clinical trials. SAEs denote events involving death, life-threatening conditions, significant disability/incapacity, hospitalization or prolonged hospitalization arising after KSVCBD administration in subjects.
Incidence and severity of adverse events of special interest (AESI)
Time frame: Within 24 months post-infusion
AESI including grade ≥ 3 Cytokine Release Syndrome (CRS), Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), and infections
12 secondary outcomes
Objective Response Rate (ORR)
Time frame: Within 24 months post-infusion
Minimal Residual Disease (MRD) negativity rate
Time frame: Within 24 months post-infusion
≥ CR rate
Time frame: Within 24 months post-infusion
Duration of Response (DOR)
Time frame: Within 24 months post-infusion
Time to Response (TTR)
Time frame: Within 24 months post-infusion
Progression-Free Survival (PFS)
Time frame: Within 24 months post-infusion
Overall Survival (OS)
Time frame: Within 24 months post-infusion
KSVCBD lentiviral particle concentration
Time frame: Within 24 months post-infusion
Number of CAR-positive T cells
Time frame: Within 24 months post-infusion
CAR gene copy number
Time frame: Within 24 months post-infusion
Number of CD19-positive cells
Time frame: Within 24 months post-infusion
Number of BCMA-positive cells
Time frame: Within 24 months post-infusion
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 15 Sep 2026.
- Individual participant dataSharing planned: No
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KSVCBD injection in people with Multiple Myeloma, run by Chinese PLA General Hospital at 3 sites 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 12 inclusion and 12 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 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 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.
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 Weidong Han, M.D. (+86-010-55499341, hanwdrsw@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limited toxicity (DLT) (time frame: Within 28 days post-infusion). The study lists 3 primary outcomes in all. 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 15 Sep 2026.