A Phase 1 interventional study of KSVCBD injection in Multiple Myeloma, sponsored by Chinese PLA General Hospital. Recruiting at 3 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Chinese PLA General Hospital · Phase 1, Interventional, and Treatment
Among 447 studies in Multiple Myeloma with a site in China — 237 open to participants now, 274 under way, 47 of them phase 3. Multiple Myeloma · China.
Among the 447 studies in Multiple Myeloma with a site in China, this one is the 379th largest by planned enrollment of the 405 interventional ones that give a count, is one of 53 that started in 2026, is one of 151 in phase 1, reaches primary completion later than 239 of the 273 other live ones, and was the 423rd registered.
3,760 studies on the registry are indexed under Multiple Myeloma; 769 are open to participants now.
Browse Multiple Myeloma studies →237 of the 447 studies in Multiple Myeloma with a site in China are open now. Recruiting first, the newest first:
AstraZeneca · Sites in China, United States, Australia and 15 more countries
Mabwell (Shanghai) Bioscience Co., Ltd. · Sites in China
Institute of Hematology & Blood Diseases Hospital, China · Sites in China
UCARsgen Biotech Limited · Sites in China
Chongqing Precision Biotech Co., Ltd · Sites in China
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 584 Multiple Myeloma studies recruiting now, 429 (73%) set no upper age limit and 106 (18%) stop at 75 or younger; 36 take children under 18; 24 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
447 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 216 · Phase 2 129 · Phase 3 71 · Phase 4 16
First in 2008; this study’s year is marked. 53 started in 2026.
This study's planned enrollment of 9 is below the median of 41 across 3,005 interventional studies indexed under Multiple Myeloma.
Median enrollment 40 across the 405 interventional studies, 210 across the 41 observational. Of the 58 that completed or were terminated, 18 (31%) have results posted.
This tab as a report to print or save as PDF → With an account.
187 of 447 have an industry lead sponsor. The 10 most frequent:
Chinese PLA General Hospital is the lead sponsor of 570 studies on the registry; 207 are open to participants now.
Chinese PLA General Hospital has 4 studies filed under Multiple Myeloma — fewer than ten, so there is no comparison to draw.
74 of the studies in Multiple Myeloma with a site in China that are under way reach primary completion within a year, 12 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06520176Phase 3The Affiliated People's Hospital of Ningbo UniversityComparison Study of EAP and CG Regimens for Mobilizing Hematopoietic Stem Cells in Multiple Myeloma Patients | 2026-12 |
| NCT05519085Phase 3CelgeneA Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) | 2027-01-10 |
| NCT06508983Phase 3Hangzhou Sumgen Biotech Co., Ltd.A Clinical Study Comparing SG301 Plus Pomalidomide and Dexamethasone to Placebo Plus Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma Patients | 2027-03-31 |
| NCT03319667Phase 3SanofiA Study to Investigate the Clinical Benefit of Isatuximab in Combination With Bortezomib, Lenalidomide and Dexamethasone in Adults With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant | 2027-04-05 |
| NCT06895512Phase 3Shanghai Henlius BiotechA Study to Evaluate the Efficacy and Safety of HLX15-IV Versus DARZALEX® in Combination with Lenalidomide-Dexamethasone (Rd) in Transplant-ineligible Patients with Newly Diagnosed Multiple Myeloma | 2027-07 |
Among the 447 studies in Multiple Myeloma with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Key Inclusion Criteria:
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 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 at screening as determined by any of the following criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Administered by IV infusion
Biological: KSVCBD injection
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
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
Time frame: 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.
Time frame: 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
Time frame: Within 24 months post-infusion
Objective Response Rate (ORR)
ORR includes Stringent Complete Remission (sCR), CR, Very Good Partial Remission (VGPR), and PR.
Time frame: Within 24 months post-infusion
Minimal Residual Disease (MRD) negativity rate
Rate of achieving MRD negativity
Time frame: Within 24 months post-infusion
≥ CR rate
Rate of achieving ≥ CR (CR and sCR)
Time frame: 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
Time frame: Within 24 months post-infusion
Time to Response (TTR)
Time from administration to first documented PR or better.
Time frame: Within 24 months post-infusion
Progression-Free Survival (PFS)
Time from administration to disease progression or death from any cause, whichever occurs first.
Time frame: Within 24 months post-infusion
Overall Survival (OS)
Time from administration to death from any cause.
Time frame: Within 24 months post-infusion
KSVCBD lentiviral particle concentration
KSVCBD lentiviral particle concentration in peripheral blood.
Time frame: Within 24 months post-infusion
Number of CAR-positive T cells
Number of CAR-positive T cells in peripheral blood.
Time frame: Within 24 months post-infusion
CAR gene copy number
CAR gene copy number in peripheral blood.
Time frame: Within 24 months post-infusion
Number of CD19-positive cells
Number of CD19-positive cells in peripheral blood.
Time frame: Within 24 months post-infusion
Number of BCMA-positive cells
Number of BCMA-positive cells in peripheral blood.
Time frame: Within 24 months post-infusion
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2026 (actual). Primary completion is estimated for Dec 2028, 27 months after the start.
Of 201 non-industry phase 1 interventional studies under Multiple Myeloma, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 39 and three quarters within 99. This study's planned 27 months is below that.
Counting every sponsor, half of 413 studies reached it within 50 months; a quarter within 33 and three quarters within 75.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Ksvcbd
Chinese PLA General Hospital →