Multiple MyelomaPhase 1NCT05346198
Evaluate CART-BCMA in Patients With Relapsed and/or Refractory Multiple Myeloma
A Phase 1 study testing CART-BCMA in people with Multiple Myeloma, run by Shanghai Simnova Biotechnology Co.,Ltd. at 2 sites in China.
Trial summary
This is a Phase 1, multicenter, open-label study o evaluate the safety and efficacy of CART-BCMA in subjects with relapsed/refractory multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- CART-BCMA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesChina
- Study dates
- 12 Mar 2021to 31 Dec 2024
- Phase
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years old (inclusive), gender is not limited;
- Multiple myeloma patients who have received at least 3-line previous multiple myeloma therapy and have failed at least through proteasome inhibitors and immunomodulators; Each line of treatment has at least 1 complete treatment cycle, unless the best remission for the treatment is recorded as disease progression (PD) (according to the IMWG Efficacy Evaluation Criterialpublished in 2016, Appendix 4); PD must be recorded during or within 12 months after the last treatment;
- Bone marrow specimens were confirmed by immunohistochemistry or flow cytometry as positive BCMA expression in plasma cells and myeloma cells (>5%);
- The presence of measurable lesions during screening was defined as any of the following:
- Serum M protein ≥1 g/dL (≥10 g/L); Urinary M protein level ≥200 mg/24 h; Serum light chain (FLC) : abnormal serum FLC ratio (< 0.26 or > 1.65), and affected FLC≥10 mg/dL (100mg/L);
- ECOG score (Appendix 1) 0~1;
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- Expected survival time ≥3 months;
- The mononuclear cells meet the following standards within 3 days before collection:
- Hematology:≥0.5×109/L[The use of past granulocyte colony stimulating factor (G-CSF) is allowed, but patients shall not receive this supportive treatment within 7 days prior to the screening phase of laboratory examination];≥1.0 ×109 /L[Ex-granulocyte colony-stimulating factor (G-CSF) is allowed, but subjects shall not receive this supportive treatment within 7 days prior to the screening laboratory examination];Subjects' platelet count ≥50×109/L (Subjects shall not receive blood transfusion support within 7 days before the screening laboratory examination);≥8.0 g/dL (Recombinant Human Erythropoietin is allowed) [Subjects have not received a red blood cell infusion (RBC) within 7 days prior to the screening phase laboratory examination]; Heart:Left ventricular ejection fraction (LVEF) ≥ 50%; Lung:Blood oxygen saturation ≥91% under non-inhaled oxygen condition; Kidney:Creatinine clearance (CRCL) or glomerular filtration rate (GFR) (Cockcroft-Gault formula) ≥30 mL/min; Liver:Total bilirubin (serum) ≤1.5 × ULN;Gilbert's disease patients with >1.5 × ULN could be enrolled with the consent of the Sponsor; Blood coagulation:Plasma prothrombin time (PT) ≤1.5 × ULN, international standardized ratio (INR) ≤1.5 × ULN, partial prothrombin time (APTT) ≤1.5 × ULN;
- Peripheral venous access can meet the needs of single collection and intravenous drip;
- The subject agrees to use reliable contraceptive methods for contraception within 1 year after signing the informed consent form to the infusion. Including but not limited to: abstinence, men undergoing vasectomy, implantable progesterone contraceptives that can inhibit ovulation; intrauterine contraceptive devices; hormone-releasing intrauterine devices; sexual partner sterilization methods; copper intrauterine devices, Correct use of proven compound hormonal contraceptives that can inhibit ovulation; progesterone contraceptives that can inhibit ovulation. At the same time, female subjects should promise not to donate eggs (egg cells, oocytes) for assisted reproduction within 1 year after the infusion;
- Volunteer to participate in clinical trials and sign Informed Consent Form;
Who cannot join
- Subjects who are known to have allergic reactions, hypersensitivity, intolerance, or contraindications to any component of CART-BCMA or any drugs that may be used in the study (including fludarabine, cyclophosphaamide, or tozumab), or who are allergic to β-lactam antibiotics, or who have had severe allergic reactions in the past;
- Prior to any CAR-T therapy or BCMA-targeted therapy;
- Have received the following anti-MM treatment within the prescribed time range before single calyzer:
- Has received small molecule targeted therapy within 4 weeks or 5 half-lives, whichever is longer; treatment with a large molecule within 4 weeks or 2 half-lives, whichever is longer; received cytotoxic therapy, proteasome inhibitor, or modern Chinese medicine preparation with anti-tumor effect within 2 weeks; received immunomodulatory drug therapy within 1 week; received radiotherapy within 1 week
- Participated in a clinical trial within 4 weeks before the single collection;
- Patients who received autologous hematopoietic stem cell transplantation (ASCT) or previous allogeneic stem cell transplantation within 12 weeks before a single collection (no time limit);
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- People who received live vaccine or attenuated vaccine within 4 weeks before the CART-BCMA harvest; Note: Inactivated viral vaccines for seasonal influenza are allowed for injection; Intranasally administered live attenuated influenza vaccines are not allowed;
- Received any of the following treatments within 7 days prior to the single collection or as determined by the investigator to require long-term treatment during the study period:
- Systemic steroid therapy (except inhalation or topical use), Immunosuppressive therapy, Graft versus host therapy, Preventive treatment of central nervous system
- Incomplete recovery or stabilization to grade 1 (NCI-CTCAE v5.0) of toxicity (including peripheral neuropathy) caused by previous treatment;
- MM is suspected to be involved in the central nervous system or meninges and confirmed by MRI or CT, or to have other active central nervous system diseases;
- Patients with plasma cell leukemia or Waldenstrom macroglobulinemia or POEMS syndrome (polyneuropathy, organ enlargement, endocrine disorder, monoclonal protein, and cutaneous disease) or amyloidosis at the time of screening;
- Heart disease: Existing heart failure (NYHA classification ≥II, Appendix 2), unstable angina pectoris, or severe heart disease as determined by the investigator; Myocardial infarction had occurred no more than 6 months before single arthroplasty. Had an episode of unstable angina pectoris, severe arrhythmia as determined by the researchers, or had undergone coronary artery bypass grafting (CABG) no more than 3 months before the single harvest;
- Poor control of hypertension (systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg) or with hypertensive crisis or hypertensive encephalopathy;
- Patients who had undergone major surgery or plasma separation other than diagnosis or biopsy within 4 weeks prior to the study alone, or who were expected to undergo major surgery during the study period; Note: Patients who plan to undergo surgery under local anesthesia may participate in the study. Kyphoplasty or vertebra osteoplasty are not considered major surgery;
- Receiving thrombolytic, anticoagulant or antiplatelet therapy;
- Infections require intravenous antibiotics or hospitalization;
- Patients with active hepatitis B; Hepatitis C virus (HCV) antibody positive; HIV-positive persons; Syphilis primary screening antibody positive; A) Inactive/asymptomatic patients with carryable, chronic, or active HBV who meet the following criteria are eligible for inclusion: HBV DNA <500 IU/mL (or 2500 copies /mL) at the time of screening.
- Women who are pregnant or lactating;
- The investigator considers that the subject is unsuitable to participate in this clinical study due to any abnormal clinical or laboratory examination or other reasons.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Hematology Department of the First Affiliated Hospital of Zhejiang University
Hangzhou
Hematology Department of Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan
About this study
Official title: A Phase I Clinical Trial to Evaluate CART-BCMA in Patients With Relapsed and/or Refractory Multiple Myeloma
This is a Phase 1, multicenter, open-label study o evaluate the safety and efficacy of CART-BCMA in subjects with relapsed/refractory multiple myeloma.
Read the detailed description
The study will consist of 2 parts: dose-escalation (Part A) and dose-expansion (Part B). The dose-escalation part (Part A) of the study is to evaluate the safety and tolerability of increasing dose levels of CART-BCMA to establish a recommended dose (RD); and the dose-expansion part (Part B) of the study is to further evaluate the safety, pharmacokinetics/pharmacodynamics, and efficacy of CART-BCMA at the RD.
- Conditions
- Multiple Myeloma
- Being tested
- CART-BCMA
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CART-BCMADrug
The CART-BCMA (study drug) used in this study are chimeric antigen receptor specifically expressing T cells targeting BCMA.
| Study group | Role | What they receive |
|---|---|---|
| Subjects will receive CART-BCMA | Experimental | Biological: CART-BCMA Subjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) to produce CART-BCMA.
During CART-BCMA production, subjects may receive bridging chemotherapy for disease control. Upon successful generation of CART-BCMA product, subjects will receive treatment with CART-BCMA therapy.
Study treatment will include lymphodepleting chemotherapy followed by one dose of CART-BCMA administered by intravenous (IV) injection. Receives: Drug: CART-BCMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of all adverse events and serious adverse events
The safety and tolerability of CART-BCMA were evaluated according to the the incidence of all adverse events and serious adverse events
Measured: Day 1 through Month 24
BCMA-CART Maximum Tolerable Dose (MTD) and/or Recommends Dose (RD)
BCMA-CART Maximum Tolerable Dose (MTD) and/or Recommends Dose (RD)
Measured: Day 1 through Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start12 Mar 2021
- Primary completion31 Jul 2022
- Study completion31 Dec 2024 (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.
- 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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Simnova Biotechnology Co.,Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05346198
- Sponsor's protocol ID
- B03B00301-101
- Status last verified
- Jan 2024
- First submitted
- 19 Apr 2022
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial to Evaluate CART-BCMA in Patients With Relapsed and/or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT05346198
- Acronym / sponsor ID
- B03B00301-101
- Conditions
- Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Shanghai Simnova Biotechnology Co.,Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Mar 2021 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 26 Apr 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 1, multicenter, open-label study o evaluate the safety and efficacy of CART-BCMA in subjects with relapsed/refractory multiple myeloma.
Detailed description
The study will consist of 2 parts: dose-escalation (Part A) and dose-expansion (Part B). The dose-escalation part (Part A) of the study is to evaluate the safety and tolerability of increasing dose levels of CART-BCMA to establish a recommended dose (RD); and the dose-expansion part (Part B) of the study is to further evaluate the safety, pharmacokinetics/pharmacodynamics, and efficacy of CART-BCMA at the RD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects will receive CART-BCMA | Experimental | Drug: CART-BCMABiological: CART-BCMA Subjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) to produce CART-BCMA. During CART-BCMA production, subjects may receive bridging chemotherapy for disease control. Upon successful generation of CART-BCMA product, subjects will receive treatment with CART-BCMA therapy. Study treatment will include lymphodepleting chemotherapy followed by one dose of CART-BCMA administered by intravenous (IV) injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- At least 18 years old (inclusive), gender is not limited;
- Multiple myeloma patients who have received at least 3-line previous multiple myeloma therapy and have failed at least through proteasome inhibitors and immunomodulators; Each line of treatment has at least 1 complete treatment cycle, unless the best remission for the treatment is recorded as disease progression (PD) (according to the IMWG Efficacy Evaluation Criterialpublished in 2016, Appendix 4); PD must be recorded during or within 12 months after the last treatment;
- Bone marrow specimens were confirmed by immunohistochemistry or flow cytometry as positive BCMA expression in plasma cells and myeloma cells (>5%);
- The presence of measurable lesions during screening was defined as any of the following:
- Serum M protein ≥1 g/dL (≥10 g/L); Urinary M protein level ≥200 mg/24 h; Serum light chain (FLC) : abnormal serum FLC ratio (< 0.26 or > 1.65), and affected FLC≥10 mg/dL (100mg/L);
Key exclusion criteria (20 listed)
- Subjects who are known to have allergic reactions, hypersensitivity, intolerance, or contraindications to any component of CART-BCMA or any drugs that may be used in the study (including fludarabine, cyclophosphaamide, or tozumab), or who are allergic to β-lactam antibiotics, or who have had severe allergic reactions in the past;
- Prior to any CAR-T therapy or BCMA-targeted therapy;
- Have received the following anti-MM treatment within the prescribed time range before single calyzer:
- Has received small molecule targeted therapy within 4 weeks or 5 half-lives, whichever is longer; treatment with a large molecule within 4 weeks or 2 half-lives, whichever is longer; received cytotoxic therapy, proteasome inhibitor, or modern Chinese medicine preparation with anti-tumor effect within 2 weeks; received immunomodulatory drug therapy within 1 week; received radiotherapy within 1 week
- Participated in a clinical trial within 4 weeks before the single collection;
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 |
|---|---|---|
| CART-BCMAThe CART-BCMA (study drug) used in this study are chimeric antigen receptor specifically expressing T cells targeting BCMA. | Drug | Subjects will receive CART-BCMA |
Primary outcome
The incidence of all adverse events and serious adverse events
Time frame: Day 1 through Month 24
The safety and tolerability of CART-BCMA were evaluated according to the the incidence of all adverse events and serious adverse events
BCMA-CART Maximum Tolerable Dose (MTD) and/or Recommends Dose (RD)
Time frame: Day 1 through Month 24
BCMA-CART Maximum Tolerable Dose (MTD) and/or Recommends Dose (RD)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 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 CART-BCMA in people with Multiple Myeloma, run by Shanghai Simnova Biotechnology Co.,Ltd. at 2 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 20 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 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of all adverse events and serious adverse events (time frame: Day 1 through Month 24). The study lists 2 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 23 Feb 2024.