Multiple MyelomaEarly Phase 1NCT06359509
Study of SYS6020 in BCMA-positive Multiple Myeloma
A Early Phase 1 study testing BCMA Targeted CAR T-cells in people with Multiple Myeloma, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
Trial summary
This is a multi-center, phase I trial that studies the efficacy and recommended dose of BCMA CART cells in treating patients with BCMA-positive multiple myeloma (MM) that have not respond or relapsed after chemotherapy. 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?
- BCMA Targeted CAR T-cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Apr 2024to May 2032
- Phase
- Early 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. ≥ 18 years of age at the time of signing informed consent;
- 2. Cytology or tissue biopsy meets diagnostic criteria for multiple myeloma (according to IMWG criteria);
- 3. Bone marrow specimens confirmed positive BCMA expression in plasma cells and myeloma cells by immunohistochemistry or flow cytometry (>5%);
- 4. Have measurable disease by International Myeloma Working Group (IMWG) criteria based on one or more of the following findings:
- Serum M-protein≥ 1 g/dL（≥10 g/L）
- Urine M-protein ≥ 200 mg/24 hour
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- Involved serum free light chain (FLCs) level≥10 mg/dL with FLCs abnormal ratio (<0.26或>1.65)
- 5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
- 6. Diagnosis of MM with relapsed or refractory disease and have had at least 1 prior lines of therapy.
Who cannot join
- 1. Patients with plasmacytic leukemia or Waldenstrom's macroglobulinemia or POEMS syndrome (polyneuropathy, organ enlargement, endocrinopathy, monoclonal protein and skin lesions) or amyloidosis at screening;
- 2. Received any prior CAR-T therapy or BCMA targeted therapy;
- 3. Patients who have received autologous hematopoietic stem cell transplantation (ASCT) within 12 weeks prior to monocyte collection or history of allogeneic stem cell transplantation;
- 4. A history of immunodeficiency, including a positive HIV antibody test;
- 5. Hepatitis B surface antigen (HBsAg) positive and HBV-DNA above the lower limit of measurement or 1000 copies /mL (500 IU/mL), (whichever is lower), HCV antibody positive and HCV-RNA above the lower limit of measurement or 1000 copies /mL (whichever is lower);
- 6. Patients who, in the judgment of the investigator, need but are unable to receive prophylactic treatment for Pneumocystis, Herpes Simplex Virus (HSV), or Herpes Zoster (VZV) prior to initiation of treatment, or Syphilis confirmatory positive;
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- 7. History of Bacillus Tuberculosis (TB) treatment within 2 years prior to first medication;
- 8. Patients with a history of interstitial lung disease and/or severe lung function impairment;
- 9. Have an active bacterial, fungal, or viral infection;
- 10.A history of severe cardiovascular disease.
About this study
Official title: A Phase І Study of BCMA-targeted Chimeric Antigen Receptor T Cell (SYS6020) Injection in Relapsed or Refractory Multiple Myeloma
This is a multi-center, phase I trial that studies the efficacy and recommended dose of BCMA CART cells in treating patients with BCMA-positive multiple myeloma (MM) that have not respond or relapsed after chemotherapy. B-cell maturation antigen (BCMA), a cell surface protein expressed on malignant plasma cell, has emerged as a very selective antigen to be targeted in novel immunotherapy for MM.
- Conditions
- Multiple Myeloma
- Being tested
- BCMA Targeted CAR T-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 Targeted CAR T-cellsBiological
Each patient will receive BCMA Targeted CAR T-cells by intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| SYS6020 | Experimental | Low, medium and high doses of SYS6020 will be given. Receives: Biological: BCMA Targeted CAR T-cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs)
Incidence of adverse events (AEs)
Measured: Up to approximately 6 months
Dose limiting toxicities (DLTs)
Dose limiting toxicities (DLTs)
Measured: Up to 21 days
Secondary outcomes (3)
Overall response rate (ORR)
Overall response rate (ORR)
Measured: Up to approximately 6 months
Percentage of subjects who achieved complete response or strict complete response (CR/sCR)
Percentage of subjects who achieved complete response or strict complete response (CR/sCR)
Measured: Up to approximately 6 months
Percentage of subjects who achieved very good partial response (VGPR) and higher response rate
Percentage of subjects who achieved very good partial response (VGPR) and higher response rate
Measured: Up to approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study startApr 2024 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMay 2032 (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 Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MEI HENG, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06359509
- Sponsor's protocol ID
- SYS6020-001
- Status last verified
- Apr 2024
- First submitted
- 27 Mar 2024
- Last updated
- 11 Apr 2024
- 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 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase І Study of BCMA-targeted Chimeric Antigen Receptor T Cell (SYS6020) Injection in Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT06359509
- Acronym / sponsor ID
- SYS6020-001
- Conditions
- Multiple Myeloma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- Apr 2024 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2032 (estimated)
- First posted
- 11 Apr 2024 (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 multi-center, phase I trial that studies the efficacy and recommended dose of BCMA CART cells in treating patients with BCMA-positive multiple myeloma (MM) that have not respond or relapsed after chemotherapy. B-cell maturation antigen (BCMA), a cell surface protein expressed on malignant plasma cell, has emerged as a very selective antigen to be targeted in novel immunotherapy for MM.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SYS6020 | Experimental | Biological: BCMA Targeted CAR T-cellsLow, medium and high doses of SYS6020 will be given. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 1. ≥ 18 years of age at the time of signing informed consent;
- 2. Cytology or tissue biopsy meets diagnostic criteria for multiple myeloma (according to IMWG criteria);
- 3. Bone marrow specimens confirmed positive BCMA expression in plasma cells and myeloma cells by immunohistochemistry or flow cytometry (>5%);
- 4. Have measurable disease by International Myeloma Working Group (IMWG) criteria based on one or more of the following findings:
- 5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
Key exclusion criteria (10 listed)
- 1. Patients with plasmacytic leukemia or Waldenstrom's macroglobulinemia or POEMS syndrome (polyneuropathy, organ enlargement, endocrinopathy, monoclonal protein and skin lesions) or amyloidosis at screening;
- 2. Received any prior CAR-T therapy or BCMA targeted therapy;
- 3. Patients who have received autologous hematopoietic stem cell transplantation (ASCT) within 12 weeks prior to monocyte collection or history of allogeneic stem cell transplantation;
- 4. A history of immunodeficiency, including a positive HIV antibody test;
- 5. Hepatitis B surface antigen (HBsAg) positive and HBV-DNA above the lower limit of measurement or 1000 copies /mL (500 IU/mL), (whichever is lower), HCV antibody positive and HCV-RNA above the lower limit of measurement or 1000 copies /mL (whichever is lower);
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 Targeted CAR T-cellsEach patient will receive BCMA Targeted CAR T-cells by intravenous infusion. | Biological | SYS6020 |
Primary outcome
Incidence of adverse events (AEs)
Time frame: Up to approximately 6 months
Incidence of adverse events (AEs)
Dose limiting toxicities (DLTs)
Time frame: Up to 21 days
Dose limiting toxicities (DLTs)
3 secondary outcomes
Overall response rate (ORR)
Time frame: Up to approximately 6 months
Percentage of subjects who achieved complete response or strict complete response (CR/sCR)
Time frame: Up to approximately 6 months
Percentage of subjects who achieved very good partial response (VGPR) and higher response rate
Time frame: Up to approximately 6 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 11 Apr 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing BCMA Targeted CAR T-cells in people with Multiple Myeloma, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.
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 9 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: opening soon, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
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?
Incidence of adverse events (AEs) (time frame: Up to approximately 6 months). 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 11 Apr 2024.