Relapsed or Refractory Multiple MyelomaPhase 1NCT04194931
Humanized CAR-T Cells of Anti-BCAM and Anti-CD19 Against Relapsed and Refractory Multiple Myeloma
A Phase 1 study testing Autologous BCMA CAR-T cells and CD19 CAR-T cells in people with Relapsed or Refractory Multiple Myeloma, run by The First Affiliated Hospital of Nanchang University at 1 site in China.
Trial summary
This is a single arm, open-label, single center study to evaluate the safety and efficacy of BCMA/CD19 CAR-T cells in patients with BCMA+，CD19+ relapsed or refractory multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Relapsed or Refractory Multiple Myeloma
- What is being tested?
- Autologous BCMA CAR-T cells and CD19 CAR-T cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2019to 31 Dec 2020
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 18-70 years old
- Estimated Survival time > 12 weeks
- Relapsed and refractory multiple myeloma were confirmed by physical examination, pathological examination, laboratory examination and imaging
- Chemotherapy failure or recurrent multiple myeloma
- Glutamic-pyruvic transaminase, glutamic oxalacetic transaminase< 3 fold of normal level
- Bilirubin<2.0mg/dl
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- Karnofsky Performance Status>50% at the time of screening
- Adequate pulmonary, renal, hepatic, and cardiac function
- Fail in autologous haemopoietic stem cell transplantation
- Not suitable for stem cell transplantation conditions or abandoned due to conditions
- Free of leukocytes removal contraindications
- Voluntarily join CAR-T clinical trial ,Understand and sign written informed consent
Who cannot join
- The patient is a pregnant or breastfeeding woman, or is a woman with a pregnancy plan within six months
- Patients have infectious diseases (such as HIV, active tuberculosis, etc.)
- The patient is an active hepatitis B or hepatitis C infection
- Feasibility assessment proves that the efficiency of transduction of lymphocyte is below 10% or the lymphocyte cannot be propagated
- Abnormal vital signs
- Subjects with mental or psychological illness who cannot be combined with treatment and efficacy evaluation.
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- Highly allergic constitution or history of severe allergies, especially allergy to interleukin-2
- General infection or local severe infection, or other infection that is not controlled
- Dysfunction in lung, heart, kidney and brain
- Severe autoimmune diseases
- Other symptoms that are not applicable for CAR-T
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Nangchang University
Nanchang, Jiangxi, 330006
Fei LI, M.D., Ph.D., +86-139-7003-8386, yx021021@sina.com
About this study
Official title: Study Evaluating the Safety and Efficacy With Sequential Infusion of Humanized CAR-T Cells of Anti-BCAM and Anti-CD19 Against Relapsed and Refractory Multiple Myeloma
This is a single arm, open-label, single center study to evaluate the safety and efficacy of BCMA/CD19 CAR-T cells in patients with BCMA+，CD19+ relapsed or refractory multiple myeloma.
Read the detailed description
CD19 has been extensively evaluated as a therapeutic target for relapsed or refractory multiple myeloma by chimeric antigen receptor T cell therapy,this is a single arm, open-label, single center study to preliminary explore the safety, tolerability and cellular pharmacokinetics of Anti-BCMA and Anti-CD19 CAR-T cells in the treatment of relapsed or refractory multiple myeloma.
- Conditions
- Relapsed or Refractory Multiple Myeloma
- Being tested
- Autologous BCMA CAR-T cells and CD19 CAR-T cells
- Keywords
- Relapsed and refractory multiple myeloma; CAR-T
- 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.
Autologous BCMA CAR-T cells and CD19 CAR-T cellsBiological
Autologous BCMA CAR-T cells and CD19 CAR-T cells with average 1-5*10^6 cells/kg body weight,separately.
| Study group | Role | What they receive |
|---|---|---|
| Mixed BCMA/CD19 CAR-T Transfer | Experimental | Subjects with BCMA/CD19+ multiple myeloma will be infused with CD19-targeting CAR T Cells and BCMA-targeting CAR T Cells in one time or in parts Receives: Biological: Autologous BCMA CAR-T cells and CD19 CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR)
Assessment of ORR (ORR = sCR+CR+VGPR+PR ) at 1 months of treatment
Measured: 2 year
minimal residual disease（MRD）
Assessment of MRD negative overall response rate at 3 months of treatment
Measured: 2 year
Progression-free survival (PFS)
Assessment of Progression-free survival (PFS) at 6 months of treatment
Measured: 2 year
Overall survival (OS)
Assessment of overall survival (OS) at 6 months of treatment
Measured: 2 year
Secondary outcomes (2)
Safety (incidence of adverse events defined as dose-limited toxicity)
Occurrence of study related adverse events defined as NCI CTCAE 4.0 > grade 3 possibly, probably, or definitely related to study treatment.
Measured: Study treatment until Week 24
Expression of CD19 CART cells
Expression of CD19 CART cells in blood, bone marrow by Quantitative Polymerase Chain Reaction (q-PCR) and by flow cytometry.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start1 Dec 2019 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Nanchang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LiFei,M.D., Ph.D., The First Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04194931
- Sponsor's protocol ID
- 2018028
- Status last verified
- Dec 2019
- First submitted
- 9 Dec 2019
- Last updated
- 11 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Evaluating the Safety and Efficacy With Sequential Infusion of Humanized CAR-T Cells of Anti-BCAM and Anti-CD19 Against Relapsed and Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT04194931
- Acronym / sponsor ID
- 2018028
- Conditions
- Relapsed or Refractory Multiple Myeloma
- Keywords
- Relapsed and refractory multiple myeloma; CAR-T
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Nanchang UniversityUniversity, hospital or other
- Study start
- 1 Dec 2019 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 11 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.
This is a single arm, open-label, single center study to evaluate the safety and efficacy of BCMA/CD19 CAR-T cells in patients with BCMA+，CD19+ relapsed or refractory multiple myeloma.
Detailed description
CD19 has been extensively evaluated as a therapeutic target for relapsed or refractory multiple myeloma by chimeric antigen receptor T cell therapy,this is a single arm, open-label, single center study to preliminary explore the safety, tolerability and cellular pharmacokinetics of Anti-BCMA and Anti-CD19 CAR-T cells in the treatment of relapsed or refractory 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 |
|---|---|---|
| Mixed BCMA/CD19 CAR-T Transfer | Experimental | Biological: Autologous BCMA CAR-T cells and CD19 CAR-T cellsSubjects with BCMA/CD19+ multiple myeloma will be infused with CD19-targeting CAR T Cells and BCMA-targeting CAR T Cells in one time or in parts |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male or female aged 18-70 years old
- Estimated Survival time > 12 weeks
- Relapsed and refractory multiple myeloma were confirmed by physical examination, pathological examination, laboratory examination and imaging
- Chemotherapy failure or recurrent multiple myeloma
- Glutamic-pyruvic transaminase, glutamic oxalacetic transaminase< 3 fold of normal level
Key exclusion criteria (11 listed)
- The patient is a pregnant or breastfeeding woman, or is a woman with a pregnancy plan within six months
- Patients have infectious diseases (such as HIV, active tuberculosis, etc.)
- The patient is an active hepatitis B or hepatitis C infection
- Feasibility assessment proves that the efficiency of transduction of lymphocyte is below 10% or the lymphocyte cannot be propagated
- Abnormal vital signs
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 |
|---|---|---|
| Autologous BCMA CAR-T cells and CD19 CAR-T cellsAutologous BCMA CAR-T cells and CD19 CAR-T cells with average 1-5*10^6 cells/kg body weight,separately. | Biological | Mixed BCMA/CD19 CAR-T Transfer |
Primary outcome
Overall response rate (ORR)
Time frame: 2 year
Assessment of ORR (ORR = sCR+CR+VGPR+PR ) at 1 months of treatment
minimal residual disease（MRD）
Time frame: 2 year
Assessment of MRD negative overall response rate at 3 months of treatment
Progression-free survival (PFS)
Time frame: 2 year
Assessment of Progression-free survival (PFS) at 6 months of treatment
Overall survival (OS)
Time frame: 2 year
Assessment of overall survival (OS) at 6 months of treatment
2 secondary outcomes
Safety (incidence of adverse events defined as dose-limited toxicity)
Time frame: Study treatment until Week 24
Expression of CD19 CART cells
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2019.
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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 Phase 1 study testing Autologous BCMA CAR-T cells and CD19 CAR-T cells in people with Relapsed or Refractory Multiple Myeloma, run by The First Affiliated Hospital of Nanchang University 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 12 inclusion and 11 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 11 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?
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?
Contact Fei LI, M.D.;Ph.D. (+86-139-7003-8386, yx021021@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) (time frame: 2 year). The study lists 4 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 Dec 2019.