Multiple MyelomaPhase 1NCT04003168
Human BCMA Targeted T Cells Injection Therapy for BCMA-positive Relapsed/Refractory Multiple Myeloma
A Phase 1 study testing Human BCMA targeted T Cells Injection in people with Multiple Myeloma, run by Hrain Biotechnology Co., Ltd. at 3 sites in China.
Trial summary
To evaluate the safety and efficacy of Human BCMA Targeted T Cells Injection for the treatment of BCMA-positive relapsed/refractory multiple myeloma. Patients will be given a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of BCMA CAR+ T cells. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Human BCMA targeted T Cells Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 3 sitesChina
- Study dates
- 1 Jul 2019to Jul 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects volunteer to participate in clinical research, understand and know the research and sign informed consent document, willing to complete all the trial procedures;
- 18 to 70 Years Old, Male and female;
- Expected survival > 12 weeks;
- Previously diagnosed as multiple myeloma by IMWG updated criteria (2014);
- Patients with positive pathological test results or flow cytometry proving that BCMA expression of malignant plasma cells in bone marrow or plasma cell tumors ≥30%;
- One of the following indicators is satisfied:
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- Serum M protein IgG ≥ 10 g/L, or IgA > 10 mg/L, or IgD > 5 mg/L;
- Urine M protein ≥ 200 mg/24h;
- Serum free light chain ≥ 100 mg/L;
- Patients with relapsed/refractory multiple myeloma. Relapsed is defined as:
- Patients have disease progression after at least three-line treatment regimens. Patients previously received at least 3 different mechanisms treatment regimens for multiple myeloma, including protease inhibitors and immunomodulators, and have disease progression within 60 days of the latest treatment ; Refractory is defined as: Patients who achieved remission in the piror therapies, have disease progression within 60 days, or after the latest therapy.
- Those who relapse 90 days after stem cell transplantation
- ECOG score 0-1;
- Liver, kidney and cardiopulmonary functions meet the following requirements:
- Creatinine clearance (estimated by Cockcroft Gault formula) ≥ 40 mL/min;
- Left ventricular ejection fraction >50%;
- Baseline peripheral oxygen saturation >95%;
- Total bilirubin ≤ 2×ULN; ALT and AST ≤2.5 × ULN;
- The venous access required for collection can be established, and no leukocyte collection contraindications.
Who cannot join
- Accompanied by other uncontrolled malignancies;
- Subjects with positive HBsAg or HBcAb and peripheral blood HBV DNA titer is higher than the lower limit of detection of the research institution; HCV antibody positive and peripheral blood HCV RNA positive; HIV antibody positive; syphilis primary screening antibody positive;
- Any instability of systemic disease, including but not limited to unstable angina, cerebrovascular accident, or transient cerebral ischemic (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), congestive heart failure (New York heart association (NYHA) classification ≥ III), severe arrhythmia, liver, kidney or metabolic disease with poor drug control;
- Patients who are accounted to be not appropriate for this trail by investigator;
- Pregnant or lactating, or planning to have a pregnancy during or within 1 year after treatment;
- Received CAR-T treatment or other gene therapies before enrollment;
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- Those who failed to sign informed consent form or comply with the research procedures; Unwilling or unable to comply with research requirements;
- Have had severe immediate hypersensitivity reactions to any drugs used in this research;
- The presence or suspicion of fungi, bacteria, viruses or other infections that are uncontrollable or requiring intravenous treatment;
- In the past two years, the terminal organ was damaged due to autoimmune diseases (such as crohn's disease, rheumatoid arthritis, systemic lupus erythematosus), or the systemic use of immunosuppressive or other systemic disease control drugs was required;
- Have a history of central nervous system (CNS) disease, such as epilepsy, seizures, paralysis, aphasia, stroke, severe brain damage, dementia, Parkinson's disease, psychosis.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, 200003
Weijun Fu, Professor, 021-81885423, fuweijun2010@hotmail.com
- Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Kang Yu, Professor, 0577-55579486, yukang62@126.com
- Recruiting
The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine
Zhengzhou, Henan
Zhi Cheng, M.D., +(86)-139-3852-6995, clinicaltrials.chengzhi@outlook.com
About this study
Official title: A Phase I Clinical Trial to Evaluate the Safety and Efficacy of Human BCMA Targeted T Cells Injection for Subjects With BCMA-positive Relapsed/Refractory Multiple Myeloma
To evaluate the safety and efficacy of Human BCMA Targeted T Cells Injection for the treatment of BCMA-positive relapsed/refractory multiple myeloma. Patients will be given a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of BCMA CAR+ T cells.
Read the detailed description
Participants with BCMA-positive relapsed/refractory multiple myeloma can participate if all eligibility criteria are met. Tests required to determine eligibility include disease assessments, a physical exam, Electrocardiograph, CT/MRI/PET, and blood draws. Participants receive chemotherapy prior to the infusion of BCMA CAR+ T cells. After the infusion, participants will be followed for side effects and effect of BCMA CAR+ T cells. Study procedures may be performed while hospitalized.
- Conditions
- Multiple Myeloma
- Being tested
- Human BCMA targeted T Cells Injection
- Keywords
- BCMA, CAR-T, multiple myeloma, Relapsed/Refractory
- Medical subject headings
- Multiple Myeloma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human BCMA targeted T Cells InjectionDrug
Autologous genetically modified anti-BCMA CAR transduced T cells
| Study group | Role | What they receive |
|---|---|---|
| Human BCMA targeted T Cells Injection | Experimental | A single infusion of anti-BCMA CAR transduced T cells administered intravenously at a target dose of 3 to 9 x 10^6 CAR T +cells/kg. The classic "3+3" dose escalation will be applied. Receives: Drug: Human BCMA targeted T Cells Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by NCI-CTCAE 5.0
Measured: 28 days post infusion
Secondary outcomes (10)
Concentration of Anti-BCMA CAR T Cells in blood
Measured: 2 years post infusion
Concentration of Anti-BCMA CAR T Cells in bone marrow
Measured: 2 years post infusion
Pharmacodynamics (Levels of Cytokines in Serum)
Measured: 2 years post infusion
Pharmacodynamics (Content of clonal plasma cells in bone marrow)
Measured: 2 years post infusion
Overall response rate (ORR) after administration
Measured: 3 months post infusion
Negative proportion of minimal residual disease (MRD)
Measured: 28 days post infusion
Duration of remission (DOR) after administration
Measured: 2 years post infusion
Progress Free Survival (PFS) after administration
Measured: 2 years post infusion
Overall Survival (OS)after administration
Measured: 2 years post infusion
Positive incidence of anti-drug antibody
Measured: 2 years post infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start1 Jul 2019
- Primary completionJul 2022 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hrain Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Changzheng Hospital, First Affiliated Hospital of Wenzhou Medical University, The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04003168
- Sponsor's protocol ID
- HRAIN01-MM01
- Status last verified
- Feb 2021
- First submitted
- 24 Jun 2019
- Last updated
- 1 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang H, Tsao ST, Gu M, Fu C, He F, Li X, Zhang M, Li N, Hu HM. A simple and effective method to purify and activate T cells for successful generation of chimeric antigen receptor T (CAR-T) cells from patients with high monocyte count. J Transl Med. 2022 Dec 19;20(1):608. doi: 10.1186/s12967-022-03833-6.
PubMed 36536403
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial to Evaluate the Safety and Efficacy of Human BCMA Targeted T Cells Injection for Subjects With BCMA-positive Relapsed/Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT04003168
- Acronym / sponsor ID
- HRAIN01-MM01
- Conditions
- Multiple Myeloma
- Keywords
- BCMA, CAR-T, multiple myeloma, Relapsed/Refractory
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Hrain Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Changzheng Hospital, First Affiliated Hospital of Wenzhou Medical University, The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 1 Jul 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.
To evaluate the safety and efficacy of Human BCMA Targeted T Cells Injection for the treatment of BCMA-positive relapsed/refractory multiple myeloma. Patients will be given a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of BCMA CAR+ T cells.
Detailed description
Participants with BCMA-positive relapsed/refractory multiple myeloma can participate if all eligibility criteria are met. Tests required to determine eligibility include disease assessments, a physical exam, Electrocardiograph, CT/MRI/PET, and blood draws. Participants receive chemotherapy prior to the infusion of BCMA CAR+ T cells. After the infusion, participants will be followed for side effects and effect of BCMA CAR+ T cells. Study procedures may be performed while hospitalized.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Human BCMA targeted T Cells Injection | Experimental | Drug: Human BCMA targeted T Cells InjectionA single infusion of anti-BCMA CAR transduced T cells administered intravenously at a target dose of 3 to 9 x 10^6 CAR T +cells/kg. The classic "3+3" dose escalation will be applied. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Subjects volunteer to participate in clinical research, understand and know the research and sign informed consent document, willing to complete all the trial procedures;
- 18 to 70 Years Old, Male and female;
- Expected survival > 12 weeks;
- Previously diagnosed as multiple myeloma by IMWG updated criteria (2014);
- Patients with positive pathological test results or flow cytometry proving that BCMA expression of malignant plasma cells in bone marrow or plasma cell tumors ≥30%;
Key exclusion criteria (11 listed)
- Accompanied by other uncontrolled malignancies;
- Subjects with positive HBsAg or HBcAb and peripheral blood HBV DNA titer is higher than the lower limit of detection of the research institution; HCV antibody positive and peripheral blood HCV RNA positive; HIV antibody positive; syphilis primary screening antibody positive;
- Any instability of systemic disease, including but not limited to unstable angina, cerebrovascular accident, or transient cerebral ischemic (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), congestive heart failure (New York heart association (NYHA) classification ≥ III), severe arrhythmia, liver, kidney or metabolic disease with poor drug control;
- Patients who are accounted to be not appropriate for this trail by investigator;
- Pregnant or lactating, or planning to have a pregnancy during or within 1 year after 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 |
|---|---|---|
| Human BCMA targeted T Cells InjectionAutologous genetically modified anti-BCMA CAR transduced T cells | Drug | Human BCMA targeted T Cells Injection |
Primary outcome
Number of participants with treatment-related adverse events as assessed by NCI-CTCAE 5.0
Time frame: 28 days post infusion
10 secondary outcomes
Concentration of Anti-BCMA CAR T Cells in blood
Time frame: 2 years post infusion
Concentration of Anti-BCMA CAR T Cells in bone marrow
Time frame: 2 years post infusion
Pharmacodynamics (Levels of Cytokines in Serum)
Time frame: 2 years post infusion
Pharmacodynamics (Content of clonal plasma cells in bone marrow)
Time frame: 2 years post infusion
Overall response rate (ORR) after administration
Time frame: 3 months post infusion
Negative proportion of minimal residual disease (MRD)
Time frame: 28 days post infusion
Duration of remission (DOR) after administration
Time frame: 2 years post infusion
Progress Free Survival (PFS) after administration
Time frame: 2 years post infusion
Overall Survival (OS)after administration
Time frame: 2 years post infusion
Positive incidence of anti-drug antibody
Time frame: 2 years post infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
- Derived from this study: PubMed 36536403Wang H, Tsao ST, Gu M, Fu C, He F, Li X, Zhang M, Li N, Hu HM. A simple and effective method to purify and activate T cells for successful generation of chimeric antigen receptor T (CAR-T) cells from patients with high monocyte count. J Transl Med. 2022 Dec 19;20(1):608. doi: 10.1186/s12967-022-03833-6.
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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.
3 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 Human BCMA targeted T Cells Injection in people with Multiple Myeloma, run by Hrain Biotechnology Co., Ltd. at 3 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 19 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 1 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Contact Hongliang Fang, doctor (021-58552006, fanghongliang@dashengbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by NCI-CTCAE 5.0 (time frame: 28 days post infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04003168, which also lists 1 linked publication.
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 1 Mar 2021.