Relapsed and Refractory Multiple MyelomaEarly Phase 1NCT03559764
Study of BCMA CAR-T in Multiple Myeloma
A Early Phase 1 study testing Anti-BCMA CAR T cells in people with Relapsed and Refractory Multiple Myeloma, run by Allife Medical Science and Technology Co., Ltd..
Trial summary
This is a single centre、single arm、open-label，to investigate the safety and efficacy of anti-BCMA CAR T cells in patients with Relapsed and Refractory multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Relapsed and Refractory Multiple Myeloma
- What is being tested?
- Anti-BCMA CAR T cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jun 2018to May 2020
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, 18 to 70 years old (including 18 and 70 years old)
- BCMA antigen diagnosed by pathology and histological examination was positive
- ECOG ≤2，and the excepted survival ≥ 3 months
- Patients with BCMA+ myeloma who received ≥ 1 line of chemoradiotherapy or tumor relapsed
- The main organs function is good; （1） liver function: ALT/AST<3 times normal value upper limit (ULN) and total bilirubin <34.2 (mol/L); （2） renal function: creatinine <220 mu /L,GFR > 30mL/min; （3） lung function: blood oxygen saturation is greater than 95%; （4） cardiac function: left ventricular ejection fraction (LVEF) is greater than 50%;
- Platelets > 40 billion/L;
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- Patients without any anti-cancer treatment such as chemotherapy，radiotherapy, immunotherapy（ immunosuppressive drugs ）within 2-4 weeks before, and the treatment-related toxicity reaction ≤1 level prior to enrollment（except low toxicity lose hair for example）
- Venous channel is unobstructed, which can meet the needs of intravenous drip;
- Voluntary informed consent is given, agree to follow the trial treatment and visit plan.
Who cannot join
- Patients with allergy to large molecules such as antibodies or cytokines;
- More than 5mg of hormones (except patients with inhaled hormone) were used within 2 to 4 weeks prior enrollment;
- Patients with severe autoimmune diseases or immunodeficiency diseases;
- Patients treated with other immune cellular products (DC, CIK, T, NK, and CART products with CD19 or other targets);
- Patients with uncontrollable infectious disease in the first 4 weeks of treatment;
- Active hepatitis B DNA > 1000copy/mL/ , hepatitis C positive, (HCV positive resistance, HCV RNA positive);
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- Patients participated in other clinical trials within 6 weeks prior enrollment;
- Patients with mental illness;
- Patients with drug abuse/addiction and medical, psychological or social conditions may interfere with the study or evaluate the results of the study;
- Patients have alcohol dependence;
- Pregnant or lactating women; Men or women who have a pregnancy plan within a year; The patients cannot guarantee effective contraceptive measures during the trial period;
- Patients had other conditions that were not appropriate for the group determined by the researchers.
About this study
Official title: Clinical Study on the Safety and Efficacy of Anti-BCMA CAR T Cells With Relapsed and Refractory Multiple Myeloma
This is a single centre、single arm、open-label，to investigate the safety and efficacy of anti-BCMA CAR T cells in patients with Relapsed and Refractory multiple myeloma.
Read the detailed description
Multiple myeloma（MM） is one of the most common malignant diseases in the blood system.There is still no cure for the disease which only control the development of the disease in various ways.CAR - T cells was taken in the form of genetic modification, and specific identified target antigen monoclonal antibody of single variable region (scFv) expression in T cell surface, and coupled with the activation of intracellular proliferation signal domain. The study will follow a 3 + 3 design of dose-escalating cohorts. After a patient enrolls,leukapheresis will be performed to obtain peripheral blood mononuclear cells which will be sent to a manufacturing site to produce anti- BCMA CAR T cells. The cells will then be returned to the investigational site and, after a standard chemotherapy based conditioning regimen, will be administered to the patient. Treated patients will undergo serial measurements of safety, tolerability and response.
In order to lay a foundation for the application of relapsed/refractory multiple myeloma patients with CAR-T therapy，objects are refractory/ relapsed patients with multiple myeloma,and plans to into the group of the number of cases in 20 cases.
- Conditions
- Relapsed and Refractory Multiple Myeloma
- Being tested
- Anti-BCMA CAR T cells
- Medical subject headings
- Recurrence, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-BCMA CAR T cellsBiological
Transparent colorless or slightly yellow liquid
| Study group | Role | What they receive |
|---|---|---|
| Anti-BCMA CAR T cells | Experimental | Total dose of 0.5-6 millions /kg cells will be administered at day -2, day -1 and day 0 by split dose (30%, 30% and 40% respectively). Receives: Biological: Anti-BCMA CAR T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety of CAR T is evaluated to determine if CRS occurred
defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment
Measured: Day 3-Year 2 after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study startJun 2018 (estimated)
- Primary completionFeb 2020 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed and Refractory 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
- Early Phase 1
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Allife Medical Science and Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03559764
- Sponsor's protocol ID
- BCMA CAR T-HNRM-01
- Status last verified
- Jun 2018
- First submitted
- 8 May 2018
- Last updated
- 18 Jun 2018
- 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 18 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Safety and Efficacy of Anti-BCMA CAR T Cells With Relapsed and Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT03559764
- Acronym / sponsor ID
- BCMA CAR T-HNRM-01
- Conditions
- Relapsed and Refractory Multiple Myeloma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Allife Medical Science and Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2018 (estimated)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 18 Jun 2018 (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 single centre、single arm、open-label，to investigate the safety and efficacy of anti-BCMA CAR T cells in patients with Relapsed and Refractory multiple myeloma.
Detailed description
Multiple myeloma（MM） is one of the most common malignant diseases in the blood system.There is still no cure for the disease which only control the development of the disease in various ways.CAR - T cells was taken in the form of genetic modification, and specific identified target antigen monoclonal antibody of single variable region (scFv) expression in T cell surface, and coupled with the activation of intracellular proliferation signal domain. The study will follow a 3 + 3 design of dose-escalating cohorts. After a patient enrolls,leukapheresis will be performed to obtain peripheral blood mononuclear cells which will be sent to a manufacturing site to produce anti- BCMA CAR T cells. The cells will then be returned to the investigational site and, after a standard chemotherapy based conditioning regimen, will be administered to the patient. Treated patients will undergo serial measurements of safety, tolerability and response.
In order to lay a foundation for the application of relapsed/refractory multiple myeloma patients with CAR-T therapy，objects are refractory/ relapsed patients with multiple myeloma,and plans to into the group of the number of cases in 20 cases.
Study design
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anti-BCMA CAR T cells | Experimental | Biological: Anti-BCMA CAR T cellsTotal dose of 0.5-6 millions /kg cells will be administered at day -2, day -1 and day 0 by split dose (30%, 30% and 40% respectively). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female, 18 to 70 years old (including 18 and 70 years old)
- BCMA antigen diagnosed by pathology and histological examination was positive
- ECOG ≤2，and the excepted survival ≥ 3 months
- Patients with BCMA+ myeloma who received ≥ 1 line of chemoradiotherapy or tumor relapsed
- The main organs function is good; （1） liver function: ALT/AST<3 times normal value upper limit (ULN) and total bilirubin <34.2 (mol/L); （2） renal function: creatinine <220 mu /L,GFR > 30mL/min; （3） lung function: blood oxygen saturation is greater than 95%; （4） cardiac function: left ventricular ejection fraction (LVEF) is greater than 50%;
Key exclusion criteria (12 listed)
- Patients with allergy to large molecules such as antibodies or cytokines;
- More than 5mg of hormones (except patients with inhaled hormone) were used within 2 to 4 weeks prior enrollment;
- Patients with severe autoimmune diseases or immunodeficiency diseases;
- Patients treated with other immune cellular products (DC, CIK, T, NK, and CART products with CD19 or other targets);
- Patients with uncontrollable infectious disease in the first 4 weeks of treatment;
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 |
|---|---|---|
| Anti-BCMA CAR T cellsTransparent colorless or slightly yellow liquid | Biological | Anti-BCMA CAR T cells |
Primary outcome
The safety of CAR T is evaluated to determine if CRS occurred
Time frame: Day 3-Year 2 after injection
defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2018.
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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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Anti-BCMA CAR T cells in people with Relapsed and Refractory Multiple Myeloma, run by Allife Medical Science and Technology Co., Ltd..
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 12 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 18 Jun 2018. 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?
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 safety of CAR T is evaluated to determine if CRS occurred (time frame: Day 3-Year 2 after injection). 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 18 Jun 2018.