Multiple MyelomaEarly Phase 1NCT04186052
Clinical Trial of BCMA CAR T Cell Infusion in Patients With BCMA-positive r/r Multiple Myeloma
A Early Phase 1 study testing BCMA-CART cells in people with Multiple Myeloma, run by PersonGen BioTherapeutics (Suzhou) Co., Ltd. at 1 site in China.
Trial summary
Multiple myeloma is a kind of hematological malignancy caused by the proliferation of malignant clonal plasma cells. In recent years, the emergence of new therapeutic drugs such as bortezomib and lenalidomide has significantly improved the therapeutic effect of 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?
- BCMA-CART cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 8 Mar 2019to 1 Mar 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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
- 1、 Chinese subjects aged 18-75
- 2、 According to the IMWG diagnostic criteria, the initial diagnosis of multiple myeloma
- 3、 The presence of measurable lesions at screening was determined by any of the following criteria：M-protein quantities≥1.0 g/dL or ≥200mg/24 hours urine collection ; Pathologically confirmed plasmacytoma; Abnormality of free light chain of serum κ / γ
- 4、 Received at least 3 lines of multiple myeloma treatment: each line has at least 1 complete treatment cycle, unless the best response to the treatment plan is recorded as Pd (according to the IMWG standard)
- 5、 Accepted a PI and an IMID
- 6、 Disease progression confirmed by examination data during or after the recent anti-myeloma treatment
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- 7、 ECOG score 0 or 1
- 8、 The clinical laboratory values during the screening period meet the following criteria: Hemoglobin ≥ 8.0 g / dL (no RBC infused within 7 days before laboratory testing ); Recombinant human erythropoietin; Platelet ≥ 50 × 109 / L(There must be no blood transfusion within 7 days before the test); ANC≥0.75×109/L (Growth factor support is allowed, but support therapy must not be received within 7 days of laboratory testing) ; AST and ALT≤3.0×ULN; Total bilirubin≤2.0×ULN, except for subjects with congenital bilirubinemia, such as Gilbert syndrome (in this case, direct bilirubin ≤1.5×ULN); Corrected serum calcium ≤12.5 mg/dL（≤3.1 mmol/L） or free ionic calcium≤6.5 mg/dL（≤1.6 mmol/L）
- 9、 The high sensitivity serum pregnancy test (β - hCG) must be negative for fertile women at screening and before the first treatment with cyclophosphamide and fludarabine
- 10、 The following requirements must be observed by women with fertility: must agree to use an effective contraceptive method (annual failure rate of continuous and correct use is less than 1%), and agree to use an effective contraceptive method continuously for at least 100 days from signing the informed consent form (ICF) to receiving lcar-b38m cell preparation infusion. Effective contraceptive methods include: Non user dependent methods: 1) Implantable progestin contraceptives that inhibit ovulation; 2)IUD; 3) Vasectomy of sexual partner; User dependency method: 1) Compound hormone contraceptives (including estrogen and progesterone) that can inhibit ovulation; 2) A progestin contraceptive (oral or injectable) that inhibits ovulation
- 11、 In addition to effective contraceptive methods, male subjects must: At least 100 days after signing ICF and receiving lcar-b38m cell infusion, when having sex with fertile women, barrier contraceptive method must be agreed; Condom must be used when having sex with pregnant women; Women and men must agree not to donate eggs (eggs, oocytes) or sperm within 100 days of the study and within 100 days of receiving the cell preparation.
- 12、 Subjects must sign the ICF to demonstrate that they understand the purpose and procedures of the study and are willing to participate in the study. Informed consent must be obtained prior to the initiation of any examination or procedure that is relevant to the subject's disease standard treatment
- 13、 Willing and able to comply with the taboos and restrictions of this program
Who cannot join
- 1、 Have received CAR-T treatment targeting any target
- 2、 Have received any treatment for targeting BCMA
- 3、 Other invasive malignancies other than multiple myeloma have been diagnosed or treated, except in the following cases: malignant tumors that have undergone radical treatment, and no known active disease within ≥3 years before enrollment; or Well-treated non-melanoma skin cancer, no evidence of disease
- 4、 Previously received the following anti-tumor treatment (before the blood of the apheresis component): targeted therapy, epigenetic therapy or experimental drug therapy within 14 days or at least 5 half-lives (whichever is shorter), or Invasive experimental medical devices have been used. Monoclonal antibodies were used to treat multiple myeloma within 21 days. Receive cytotoxic treatment within 14 days. Proteasome inhibitor treatment was received within 14 days. Received immunomodulator treatment within 7 days. Received radiation therapy within 14 days. However, if the field covers ≤5% of the bone marrow reserve, the subject is eligible to participate in the study regardless of the date of the end of radiotherapy.
- 5、 In addition to alopecia or peripheral neuropathy, the toxicity of previous anti-tumor treatments must be improved to baseline levels or ≤1
- 6、 The following heart conditions occurred: New York Heart Association (NYHA) stage III or stage IV congestive heart failure; myocardial infarction or coronary artery bypass graft (CABG) before or 6 months prior to enrollment; clinically meaningful ventricular Arrhythmia, or history of unexplained syncope, non-vascular vagal or not due to dehydration; history of severe nonischemic cardiomyopathy; assessed by echocardiography or multi-circuit detection (MUGA) scan (in front of apheresis ≤ 8 weeks), impaired cardiac function (LVEF <45%)
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- 7、 Systemic corticosteroid treatment at doses greater than 5 mg/day of prednisone (or equivalent dose of other corticosteroids) within 2 weeks prior to apheresis
- 8、 Received any of the following treatments: for the treatment of multiple myeloma, allogeneic stem cell transplantation. Apheresis has been tested for autologous stem cell transplantation within ≤12 weeks before blood collection
- 9、 A stroke or seizure occurred within 6 months prior to the signing of the ICF
- 10、 Screening for plasma cell leukemia (according to standard classification, plasma cells >2.0×109/L), Waldenstrom's macroglobulinemia, POEMS syndrome (multiple neuropathy, organ enlargement, endocrine disease, monoclonal protein disease) And skin changes) or primary AL amyloidosis
- 11、 Human immunodeficiency virus (HIV) seropositive
- 12、 Live attenuated live vaccine within 4 weeks before single blood collection
- 13、 Hepatitis B infection as defined by the American Society of Clinical Oncology (ASCO) guidelines. If the infection status is unknown, the infection level needs to be determined by the quantitative level.
- 14、 Hepatitis C (anti-hepatitis C virus [HCV] antibody positive or HCV-RNA quantitative test results positive) or known to have a history of hepatitis C
- 15、 Need oxygen to maintain adequate oxygen saturation
- 16、 It is known to have life-threatening allergic reactions, hypersensitivity reactions or intolerance to LCAR-B38M cell preparations or their excipients (including DMSO) (see the investigator's manual)
- 17、 Severe underlying conditions, such as evidence of a serious active virus, bacterial infection, or uncontrolled systemic fungal infection; active autoimmune disease or a history of autoimmune disease within 3 years; significant clinical evidence of dementia Mental state change
- 18、 Not conducive to the subject receiving or tolerating planned treatment at the research center, understanding any questions of informed consent, or any researcher believes that participating in the study does not meet the best interests of the subject (eg, impairing health), or any Prevent, limit or confuse the status of the assessment provided by the research programme
- 19、 Female subjects who were pregnant, breast-feeding, or planning to become pregnant during the study period or within 100 days of receiving the study treatment
- 20、 Male subjects who have a birth plan during the study period or within 100 days of receiving the study treatment
- 21、 Major surgery was performed within 2 weeks prior to apheresis, or planned to be performed during the study or within 2 weeks of the study treatment. (Note: Subjects scheduled for local anesthesia can participate in this study.)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hematology Department of the Second Affiliated Hospital of Suzhou University
Suzhou, Jiangsu
Bingzong Li, M.D., +8613776054037, lbzwz0907@hotmail.com
About this study
Official title: Clinical Study Protocol for Targeting BCMA Autochimeric Antigen Receptor T Cell Infusion One-arm, Single-center, Open-label Clinical Trial of BCMA Autologous Chimeric Antigen Receptor T Cell Infusion in Patients With BCMA-positive Relapsed/Refractory Multiple Myeloma
Multiple myeloma is a kind of hematological malignancy caused by the proliferation of malignant clonal plasma cells. In recent years, the emergence of new therapeutic drugs such as bortezomib and lenalidomide has significantly improved the therapeutic effect of mm. However, due to the presence of myeloma stem cells, most patients will inevitably relapse and die. With the development of biomedicine and immunology, immunotherapy with chimeric antigen receptor modified T cells has attracted great attention for its amazing efficacy. CAR-T cells carry receptors that can specifically recognize myeloma associated antigens, and their killing effect is not limited by MHC molecules. B-cell mature antigen is only expressed on the surface of B cells in germinal center, malignant and normal plasma cells, not on other normal human tissues and CD34 + hematopoietic stem cells. It is a relatively specific high expression on the surface of myeloma cells, which is an ideal target for MM immunotherapy. The aim of this study was to investigate the efficacy and safety of BCMA targeted T cell infusion in the treatment of BCMA positive multiple myeloma.
- Conditions
- Multiple Myeloma
- Being tested
- BCMA-CART cells
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCMA-CART cellsBiological
Target BCMA chimeric antigen receptor T cell infusion
| Study group | Role | What they receive |
|---|---|---|
| BCMA CAR-T cells Infusion | Experimental | Not described Receives: Biological: BCMA-CART cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety(Incidence of AE or SAE of ≥ grade 3 )
Incidence of AE or SAE of ≥ grade 3 (refer to CTCAE version 4.03) related to the study drug within 12 weeks after infusion of the study drug
Measured: 12 weeks after infusion of the study drug
Secondary outcomes (1)
Effectiveness
ORR at 12 weeks after infusion (ORR12)
Measured: 12 weeks after infusion of the study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start8 Mar 2019
- Primary completion1 Mar 2021 (estimated)
- Study completion1 Mar 2021 (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 PersonGen BioTherapeutics (Suzhou) Co., Ltd.The 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Second Affiliated Hospital of Suzhou University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04186052
- Sponsor's protocol ID
- PG-CART-BCMA-001
- Status last verified
- Dec 2019
- First submitted
- 5 Nov 2019
- Last updated
- 4 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Protocol for Targeting BCMA Autochimeric Antigen Receptor T Cell Infusion One-arm, Single-center, Open-label Clinical Trial of BCMA Autologous Chimeric Antigen Receptor T Cell Infusion in Patients With BCMA-positive Relapsed/Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT04186052
- Acronym / sponsor ID
- PG-CART-BCMA-001
- Conditions
- Multiple Myeloma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Second Affiliated Hospital of Suzhou University
- Study start
- 8 Mar 2019 (actual)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 4 Dec 2019 (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.
Multiple myeloma is a kind of hematological malignancy caused by the proliferation of malignant clonal plasma cells. In recent years, the emergence of new therapeutic drugs such as bortezomib and lenalidomide has significantly improved the therapeutic effect of mm. However, due to the presence of myeloma stem cells, most patients will inevitably relapse and die. With the development of biomedicine and immunology, immunotherapy with chimeric antigen receptor modified T cells has attracted great attention for its amazing efficacy. CAR-T cells carry receptors that can specifically recognize myeloma associated antigens, and their killing effect is not limited by MHC molecules. B-cell mature antigen is only expressed on the surface of B cells in germinal center, malignant and normal plasma cells, not on other normal human tissues and CD34 + hematopoietic stem cells. It is a relatively specific high expression on the surface of myeloma cells, which is an ideal target for MM immunotherapy. The aim of this study was to investigate the efficacy and safety of BCMA targeted T cell infusion in the treatment of BCMA positive multiple myeloma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BCMA CAR-T cells Infusion | Experimental | Biological: BCMA-CART cells |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 1、 Chinese subjects aged 18-75
- 2、 According to the IMWG diagnostic criteria, the initial diagnosis of multiple myeloma
- 3、 The presence of measurable lesions at screening was determined by any of the following criteria：M-protein quantities≥1.0 g/dL or ≥200mg/24 hours urine collection ; Pathologically confirmed plasmacytoma; Abnormality of free light chain of serum κ / γ
- 4、 Received at least 3 lines of multiple myeloma treatment: each line has at least 1 complete treatment cycle, unless the best response to the treatment plan is recorded as Pd (according to the IMWG standard)
- 5、 Accepted a PI and an IMID
Key exclusion criteria (21 listed)
- 1、 Have received CAR-T treatment targeting any target
- 2、 Have received any treatment for targeting BCMA
- 3、 Other invasive malignancies other than multiple myeloma have been diagnosed or treated, except in the following cases: malignant tumors that have undergone radical treatment, and no known active disease within ≥3 years before enrollment; or Well-treated non-melanoma skin cancer, no evidence of disease
- 4、 Previously received the following anti-tumor treatment (before the blood of the apheresis component): targeted therapy, epigenetic therapy or experimental drug therapy within 14 days or at least 5 half-lives (whichever is shorter), or Invasive experimental medical devices have been used. Monoclonal antibodies were used to treat multiple myeloma within 21 days. Receive cytotoxic treatment within 14 days. Proteasome inhibitor treatment was received within 14 days. Received immunomodulator treatment within 7 days. Received radiation therapy within 14 days. However, if the field covers ≤5% of the bone marrow reserve, the subject is eligible to participate in the study regardless of the date of the end of radiotherapy.
- 5、 In addition to alopecia or peripheral neuropathy, the toxicity of previous anti-tumor treatments must be improved to baseline levels or ≤1
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 |
|---|---|---|
| BCMA-CART cellsTarget BCMA chimeric antigen receptor T cell infusion | Biological | BCMA CAR-T cells Infusion |
Primary outcome
safety(Incidence of AE or SAE of ≥ grade 3 )
Time frame: 12 weeks after infusion of the study drug
Incidence of AE or SAE of ≥ grade 3 (refer to CTCAE version 4.03) related to the study drug within 12 weeks after infusion of the study drug
1 secondary outcome
Effectiveness
Time frame: 12 weeks after infusion of the study drug
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2019.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing BCMA-CART cells in people with Multiple Myeloma, run by PersonGen BioTherapeutics (Suzhou) Co., Ltd. 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 13 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 4 Dec 2019. 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bingzong Li, M.D. (+8613776054037, lbzwz0907@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety(Incidence of AE or SAE of ≥ grade 3 ) (time frame: 12 weeks after infusion of the study drug). 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 4 Dec 2019.