Multiple MyelomaEarly Phase 1NCT04650724
Clinical Study of T Cell Infusion Targeting BCMA Chimeric Antigen Receptor
A Early Phase 1 study testing T cell infusion agent targeting BCMA chimeric antigen receptor in people with Multiple Myeloma, run by PersonGen BioTherapeutics (Suzhou) Co., Ltd. at 1 site in China.
Trial summary
Chimeric antigen receptor T cells (car-t) is one of the most effective therapies for malignant tumors (especially hematological tumors). Like other immunotherapies, the basic principle is to use the patient's own immune cells to clear cancer cells. Read more about this study
- Who is it for?
- Ages 14 to 65 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- T cell infusion agent targeting BCMA chimeric antigen receptor
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteChina
- Study dates
- 11 Oct 2018to 1 Oct 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 14 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1. Subjects who voluntarily participated in the study and signed written informed consent;
- 2. The age of signing informed consent is 14-65 years old;
- 3. Patients with multiple myeloma were diagnosed according to the IMWG diagnostic criteria;
- 4. The expression of BCMA was confirmed by flow cytometry or immunohistochemistry;
- 5. The expected survival time was > 12 weeks;
- 6. The main researchers and attending physicians believe that there is no other feasible and effective alternative treatment, such as hematopoietic stem cell transplantation;
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- 7. Relapsed or refractory multiple myeloma (mm) A. At least one complete regimen including induction, consolidation and maintenance of proteasome inhibitors and / or immunomodulators was performed at least once, and the interval between the two regimens was more than 3 months; B. According to the criteria of IMWG, recurrence was considered; C. Refractory patients (disease progression during standard treatment; efficacy of proteasome inhibitor combined with immunomodulator less than PR; efficacy after autologous stem cell transplantation less than PR; disease progression within 6 months after transplantation; progression and recurrence within 1 year after initial treatment); D. Recurrence occurred after allogeneic SCT treatment;
- 8. The main organ functions are sound, including: A. Renal function: serum creatinine clearance rate > 40 ml / min / 1.73 m2, adjusted according to age / gender standard; B. Alanine transferase (ALT) was less than 2 times the normal maximum value of the same age; C. Bilirubin < 2.0 mg / dl; D. Echocardiography or multi gated angiography (MUGA) showed left ventricular short axis shortening (LVSF) ≥ 28%, or left ventricular ejection fraction (LVEF) ≥ 45%;
- 9. ECOG physical status (PS) ≤ 2;
- 10. The pregnant test results of fertile female subjects within 48 hours before infusion were negative, and they were not in lactation period; all subjects with reproductive potential should take adequate contraceptive measures from the beginning of the study to one year after the end of the study.
Who cannot join
- 1. Pregnant or lactating female patients;
- 2. Participate in another clinical trial within 4 weeks before enrollment (3 months in case of monoclonal antibody clinical trial) or intend to participate in another clinical trial during the whole study period;
- 3. Other anti BCMA treatments have been used in the past;
- 4. Uncontrolled active infection; for example, there is a known history of human immunodeficiency virus; active hepatitis B or hepatitis C infection; HBV-DNA detection exceeds normal, etc;
- 5. There is grade 2-4 acute or systemic chronic GVHD or GVHD under treatment;
- 6. Cns-3 disease progression, or the presence of central nervous system parenchymal lesions that may increase the central nervous system toxicity; patients with active central nervous system leukemia infiltration;
- 7. The researchers think that they are not suitable to participate in this clinical trial due to various reasons.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Arm, Single Center, Open Label Clinical Trial of BCMA Autologous Chimeric Antigen Receptor T Cell Infusion in Patients With BCMA Positive Recurrent or Refractory Multiple Myeloma
Chimeric antigen receptor T cells (car-t) is one of the most effective therapies for malignant tumors (especially hematological tumors). Like other immunotherapies, the basic principle is to use the patient's own immune cells to clear cancer cells. Chimeric antigen receptor (car) is the core component of car-t, which endows T cells with the ability to recognize tumor antigens in an independent manner, which enables car modified T cells to recognize a wider range of targets than natural T cell surface receptors (TCR). The basic design of car includes a tumor associated antigen binding region (usually derived from scFv segment of monoclonal antibody antigen binding region), transmembrane region and intracellular signal region. The selection of target antigen is a key determinant for the specificity and effectiveness of car and the safety of genetically modified T cells.
BCMA is a specific surface protein of B lymphocytes, which plays an important role in the development, proliferation and differentiation of B cells. BCMA is highly expressed in malignant mm plasma cells and provides a large number of anti apoptotic signals, which makes bcam an ideal target in targeted immunotherapy. At present, a variety of immunotherapy strategies targeting BCMA are being carried out in laboratory and clinical practice, which have achieved encouraging therapeutic effects in multiple myeloma and effectively promoted the development of targeted immunotherapy.
- Conditions
- Multiple Myeloma
- Being tested
- T cell infusion agent targeting BCMA chimeric antigen receptor
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T cell infusion agent targeting BCMA chimeric antigen receptorDrug
Chimeric antigen receptor T cells (car-t) is one of the most effective therapies for malignant tumors (especially hematological tumors). Like other immunotherapies, the basic principle is to use the patient's own immune cells to clear cancer cells. Chimeric antigen receptor (car) is the core component of car-t, which endows T cells with the ability to recognize tumor antigens in an independent manner, which enables car modified T cells to recognize a wider range of targets than natural T cell surface receptors (TCR). The basic design of car includes a tumor associated antigen binding region (usually derived from scFv segment of monoclonal antibody antigen binding region), transmembrane region and intracellular signal region. The selection of target antigen is a key determinant for the specificity and effectiveness of car and the safety of genetically modified T cells.
| Study group | Role | What they receive |
|---|---|---|
| T cell infusion agent targeting BCMA chimeric antigen receptor | Experimental | Not described Receives: Drug: T cell infusion agent targeting BCMA chimeric antigen receptor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AE or SAE
Incidence of AE or SAE with grade 3 or above related to study drug within 12 weeks of study drug infusion
Measured: Study drug infusion within 12 weeks
ORR
Objective to study the clinical objective remission rate within 12 weeks after drug infusion
Measured: Within 12 weeks after infusion of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start11 Oct 2018
- Primary completion20 Dec 2018
- Study completion1 Oct 2020
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 PersonGen BioTherapeutics (Suzhou) Co., Ltd.The 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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sir Run Run Shaw Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04650724
- Sponsor's protocol ID
- PA-CART-BCMA-001
- Status last verified
- Nov 2020
- First submitted
- 25 Nov 2020
- Last updated
- 3 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Arm, Single Center, Open Label Clinical Trial of BCMA Autologous Chimeric Antigen Receptor T Cell Infusion in Patients With BCMA Positive Recurrent or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT04650724
- Acronym / sponsor ID
- PA-CART-BCMA-001
- Conditions
- Multiple Myeloma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Sir Run Run Shaw Hospital
- Study start
- 11 Oct 2018 (actual)
- Primary completion
- 20 Dec 2018 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 3 Dec 2020 (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.
Chimeric antigen receptor T cells (car-t) is one of the most effective therapies for malignant tumors (especially hematological tumors). Like other immunotherapies, the basic principle is to use the patient's own immune cells to clear cancer cells. Chimeric antigen receptor (car) is the core component of car-t, which endows T cells with the ability to recognize tumor antigens in an independent manner, which enables car modified T cells to recognize a wider range of targets than natural T cell surface receptors (TCR). The basic design of car includes a tumor associated antigen binding region (usually derived from scFv segment of monoclonal antibody antigen binding region), transmembrane region and intracellular signal region. The selection of target antigen is a key determinant for the specificity and effectiveness of car and the safety of genetically modified T cells.
BCMA is a specific surface protein of B lymphocytes, which plays an important role in the development, proliferation and differentiation of B cells. BCMA is highly expressed in malignant mm plasma cells and provides a large number of anti apoptotic signals, which makes bcam an ideal target in targeted immunotherapy. At present, a variety of immunotherapy strategies targeting BCMA are being carried out in laboratory and clinical practice, which have achieved encouraging therapeutic effects in multiple myeloma and effectively promoted the development of targeted immunotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| T cell infusion agent targeting BCMA chimeric antigen receptor | Experimental | Drug: T cell infusion agent targeting BCMA chimeric antigen receptor |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 1. Subjects who voluntarily participated in the study and signed written informed consent;
- 2. The age of signing informed consent is 14-65 years old;
- 3. Patients with multiple myeloma were diagnosed according to the IMWG diagnostic criteria;
- 4. The expression of BCMA was confirmed by flow cytometry or immunohistochemistry;
- 5. The expected survival time was > 12 weeks;
Key exclusion criteria (7 listed)
- 1. Pregnant or lactating female patients;
- 2. Participate in another clinical trial within 4 weeks before enrollment (3 months in case of monoclonal antibody clinical trial) or intend to participate in another clinical trial during the whole study period;
- 3. Other anti BCMA treatments have been used in the past;
- 4. Uncontrolled active infection; for example, there is a known history of human immunodeficiency virus; active hepatitis B or hepatitis C infection; HBV-DNA detection exceeds normal, etc;
- 5. There is grade 2-4 acute or systemic chronic GVHD or GVHD under 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 |
|---|---|---|
| T cell infusion agent targeting BCMA chimeric antigen receptorChimeric antigen receptor T cells (car-t) is one of the most effective therapies for malignant tumors (especially hematological tumors). Like other immunotherapies, the basic principle is to use the patient's own immune cells to clear cancer cells. Chimeric antigen receptor (car) is the core component of car-t, which endows T cells with the ability to recognize tumor antigens in an independent manner, which enables car modified T cells to recognize a wider range of targets than natural T cell surface receptors (TCR). The basic design of car includes a tumor associated antigen binding region (usually derived from scFv segment of monoclonal antibody antigen binding region), transmembrane region and intracellular signal region. The selection of target antigen is a key determinant for the specificity and effectiveness of car and the safety of genetically modified T cells. | Drug | T cell infusion agent targeting BCMA chimeric antigen receptor |
Primary outcome
Incidence of AE or SAE
Time frame: Study drug infusion within 12 weeks
Incidence of AE or SAE with grade 3 or above related to study drug within 12 weeks of study drug infusion
ORR
Time frame: Within 12 weeks after infusion of study drug
Objective to study the clinical objective remission rate within 12 weeks after drug infusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2020.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing T cell infusion agent targeting BCMA chimeric antigen receptor in people with Multiple Myeloma, run by PersonGen BioTherapeutics (Suzhou) Co., Ltd. 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 10 inclusion and 7 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: finished, as of the sponsor's last update on 3 Dec 2020. 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?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 AE or SAE (time frame: Study drug infusion within 12 weeks). 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 3 Dec 2020.