Multiple MyelomaNCT05308875
Efficacy and Safety Evaluation of PD1-BCMA-CART
A study testing PD1-BCMA-CART in people with Multiple Myeloma, run by Bioray Laboratories at 1 site in China.
Trial summary
This trial aims to evaluate the safety and efficacy of PD1-BCMA-CART in treating patients with relapsed or refractory multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- PD1-BCMA-CART
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 1 Oct 2025
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have the capacity to give informed consent;
- Confirmed diagnosis of active MM as defined by NCCN and IMWG criteria;
- Have a diagnosis of BCMA+ multiple myeloma (MM), (≥ 5% BCMA+ in CD138+ plasma cells by flow cytometry obtained within 45 days of study enrollment);
- Refractory and relapsed MM patients after > 2 cycles of induction therapy,or,have relapsed or treatment refractory disease following autologous stem cell transplant (ASCT);
- ECOG score=0-2.
- Subjects according with any of the following options:
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- Age≥50;
- Failure with separation of T cells during autologous CART processing; or,
- Failure with expansion of autologous CART; or,
- The proportion of T cells in PBMC <10%; or,
- Won't benefit from autologous CART therapy because of disease progress.
Who cannot join
- Pregnant or nursing women; Women of reproductive potential must have a negative serum pregnancy test performed within 48 hours of starting conditioning chemotherapy
- Active infection, HIV infection, syphilis serology reaction positive;
- Active hepatitis B, hepatitis C at the time of screening
- Significant hepatic dysfunction as following, SGOT(serum glutamic-oxaloacetic transaminase)> 5 x upper limit of normal; bilirubin > 3.0 mg/dL;
- Lymphotoxic chemotherapeutic agents within 2 weeks of leukapheresis
- serious mental disorder;
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- With severe cardiac, liver, renal insufficiency, diabetes and other diseases;
- Participate in other clinical research in the past three months; previously treatment with any gene therapy products
- Contraindication to cyclophosphamide or fludarabine chemotherapy
Trial locations and contacts
1 site in 1 country.
China1 site
First Affliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
About this study
Official title: Clinical Study of the Safety and Efficacy of Non-viral Site-directed Integrated PD1-BCMA-CART in Adult Treatment of Relapsed or Refractory Multiple Myeloma
This trial aims to evaluate the safety and efficacy of PD1-BCMA-CART in treating patients with relapsed or refractory multiple myeloma.
Read the detailed description
Using gene editing, chimeric antigen receptors recognizing BCMA were integrated into subject self-derived T cells to obtain a large number of BCMA-CART by in vitro amplification, and BCMA-CART back into the subjects could identify and kill myeloma cells in the subjects.This open-label, dose-escalation study was designed to evaluate the safety and antitumor efficacy of PD1-BCMA-CART in the treatment of relapsed or refractory multiple myeloma.
- Conditions
- Multiple Myeloma
- Being tested
- PD1-BCMA-CART
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD1-BCMA-CARTBiological
Single infusion of PD1-BCMA-CART administered intravenously (i.v.)
| Study group | Role | What they receive |
|---|---|---|
| PD1-BCMA-CART | Experimental | Each subject will accept one of the following dosages of PD1-BCMA-CART cells intravenously (IV) on day 0: 0.5-2*10^6/KgBW. Receives: Biological: PD1-BCMA-CART |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Proportion of patients in whom a response among complete response or partial response, as defined by International Myeloma Working group(IMWG) response criteria , will be observed.
Measured: Up to 90 days after T cell infusion
Secondary outcomes (2)
Incidence and Severity of Adverse Events as a Measure of Safety and Tolerability
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Measured: Up to 35 days after T cell infusion
Duration of persistence of PD1-BCMA-CART
Detect the duration of PD1-BCMA-CART after injection using FACS or Q-PCR
Measured: Baseline up to 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start1 Mar 2024 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Oct 2025 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- 0.5-2×10\^6/kgBW
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bioray Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yi Zhang, Professor, Principal investigator, First Affliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05308875
- Sponsor's protocol ID
- 2021-BRL-202
- Status last verified
- Jul 2023
- First submitted
- 27 Jan 2022
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- 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 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of the Safety and Efficacy of Non-viral Site-directed Integrated PD1-BCMA-CART in Adult Treatment of Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT05308875
- Acronym / sponsor ID
- 2021-BRL-202
- Conditions
- Multiple Myeloma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Bioray LaboratoriesIndustry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Zhengzhou University
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 4 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 trial aims to evaluate the safety and efficacy of PD1-BCMA-CART in treating patients with relapsed or refractory multiple myeloma.
Detailed description
Using gene editing, chimeric antigen receptors recognizing BCMA were integrated into subject self-derived T cells to obtain a large number of BCMA-CART by in vitro amplification, and BCMA-CART back into the subjects could identify and kill myeloma cells in the subjects.This open-label, dose-escalation study was designed to evaluate the safety and antitumor efficacy of PD1-BCMA-CART in the treatment of relapsed or refractory multiple myeloma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 0.5-2×10^6/kgBW
| Arm | Type | Receives |
|---|---|---|
| PD1-BCMA-CART | Experimental | Biological: PD1-BCMA-CARTEach subject will accept one of the following dosages of PD1-BCMA-CART cells intravenously (IV) on day 0: 0.5-2*10^6/KgBW. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Have the capacity to give informed consent;
- Confirmed diagnosis of active MM as defined by NCCN and IMWG criteria;
- Have a diagnosis of BCMA+ multiple myeloma (MM), (≥ 5% BCMA+ in CD138+ plasma cells by flow cytometry obtained within 45 days of study enrollment);
- Refractory and relapsed MM patients after > 2 cycles of induction therapy,or,have relapsed or treatment refractory disease following autologous stem cell transplant (ASCT);
- ECOG score=0-2.
Key exclusion criteria (9 listed)
- Pregnant or nursing women; Women of reproductive potential must have a negative serum pregnancy test performed within 48 hours of starting conditioning chemotherapy
- Active infection, HIV infection, syphilis serology reaction positive;
- Active hepatitis B, hepatitis C at the time of screening
- Significant hepatic dysfunction as following, SGOT(serum glutamic-oxaloacetic transaminase)> 5 x upper limit of normal; bilirubin > 3.0 mg/dL;
- Lymphotoxic chemotherapeutic agents within 2 weeks of leukapheresis
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 |
|---|---|---|
| PD1-BCMA-CARTSingle infusion of PD1-BCMA-CART administered intravenously (i.v.) | Biological | PD1-BCMA-CART |
Primary outcome
Objective response rate (ORR)
Time frame: Up to 90 days after T cell infusion
Proportion of patients in whom a response among complete response or partial response, as defined by International Myeloma Working group(IMWG) response criteria , will be observed.
2 secondary outcomes
Incidence and Severity of Adverse Events as a Measure of Safety and Tolerability
Time frame: Up to 35 days after T cell infusion
Duration of persistence of PD1-BCMA-CART
Time frame: Baseline up to 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- 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. This study is not recruiting at the moment.
Yi Zhang, Professor principal investigator
First Affliated Hospital of Zhengzhou University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PD1-BCMA-CART in people with Multiple Myeloma, run by Bioray Laboratories 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 11 inclusion and 9 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 5 Jan 2024. 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.
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 wei Li, PhD (+8618621670308, adamweili@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: Up to 90 days after T cell infusion). 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 5 Jan 2024.