Multiple MyelomaPhase 1/2CAR-TNCT06132711
Safety and Efficacy of APRIL-BAFF-Bicephali CAR-T in Relapsed, Refractory Multiple Myeloma
A Phase 1/2 study testing APRIL-BAFF-Bicephali CAR-T cells in people with Multiple Myeloma, run by Xuzhou Medical University at 1 site in China.
Trial summary
This is a Single-center, open, single-arm clinical study, the goal of which was to evaluate the safety and efficacy of APRIL-BAFF-Bicephali CAR-T in relapsed and refractory multiple myeloma.The study consisted of four processes: patient enrollment screening; pre-CAR T cell therapy (including leukocyte apheresis, CAR T… 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?
- APRIL-BAFF-Bicephali CAR-T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2023to 1 Jan 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- The set subject inclusion criteria include multiple documents of multiple myeloma, no effective treatment options (e. g. autologous or allogeneic stem cell transplantation) and limited outcome (<2 years) with existing therapies, as follows:
- Age is 18~70 years old;
- Expected survival period of>12 weeks;
- Multiple myeloma was diagnosed by physical examination, pathological examination, laboratory examination and imaging;
- Patients with refractory multiple myeloma;
- Patients with multiple myeloma recurrence;
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- ALT and AST <3 times normal; bilirubin <2.0mg / dl;
- Quality of survival score (KPS)> 50%;
- The patient has no serious heart, liver, kidney and other diseases;
- Recurrence or no disease remission after hematopoietic stem cell transplantation or cellular immunotherapy;
- Is not suitable for stem cell transplantation conditions or to abandon transplantation due to conditional restrictions;
- Blood can be obtained intravenously, without other contraindications to leukapheresis;
- Understand and voluntarily sign a written informed consent form.
Who cannot join
- Women who are pregnant or breastfeeding, or who have a pregnancy plan within six months;
- Infectious diseases (such as HIV, active tuberculosis, etc.);
- Active hepatitis B or hepatitis C infection;
- Feasibility assessment screening demonstrated <10% transfection of targeted lymphocytes or underamplification under CD3 / CD28 co-stimulation (<5-fold);
- Abnormal vital signs, and unable to cooperate with the examination;
- Have mental or mental illness who cannot cooperate with the treatment and efficacy evaluation;
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- Highly allergic constitution or have a history of severe allergies, especially allergic to IL-2;
- Subjects with a systemic infection or a severe local infection requiring anti-infective treatment;
- Subjects with severe autoimmune disease;
- The doctor believes there were other reasons for inclusion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Kailin Xu
Xuzhou, Jiangsu, 221000
Kailin Xu, M.D., Ph.D., 15162166166, lihmd@163.com
About this study
Official title: Safety and Efficacy of APRIL-BAFF-Bicephali CAR-T in Relapsed, Refractory Multiple Myeloma-A Single-center, Open-label, Single-arm Clinical Study
This is a Single-center, open, single-arm clinical study, the goal of which was to evaluate the safety and efficacy of APRIL-BAFF-Bicephali CAR-T in relapsed and refractory multiple myeloma.The study consisted of four processes: patient enrollment screening; pre-CAR T cell therapy (including leukocyte apheresis, CAR T cell preparation and chemotherapy); inpatient monitoring phase for CAR T cell transfusion; and long-term follow-up phase
Read the detailed description
This trial is a single-center, open, single-arm trial with a non-blinded design.
The study consisted of four processes: patient enrollment screening; pre-CAR T cell therapy (including leukocyte apheresis, CAR T cell preparation and chemotherapy); inpatient monitoring phase for CAR T cell transfusion; and long-term follow-up phase. The specific execution process is as follows:
- Pre-enrollment assessment;
- Patient enrollment and basic data collection;
- Leukocyte apheresis and CAR-T cell production 3.1 Patients receive apheresis of about 12-15 liters to provide peripheral blood mononuclear cells for the preparation of CAR-T. In addition to the use of appropriate amounts of lymphocytes for CAR-T preparation, excess cells should be cryopreserved for subsequent studies and regulatory inquiries. 3.2 APRIL-BAFF Bicephali CAR-T cell preparation. 4 cells were pretreated before transfusion Pretreatment was started-5 days before CAR-T cell revertant, and CAR-T cell treatment was performed 2 days after completion of chemotherapy. The purpose of chemotherapy is to reduce the tumor load on the one hand and to reduce the number of endogenous lymphocytes to facilitate the proliferation of reinfused CAR T cells. All patients were pretreated with FC regimen, fludarabine 30mg / m2 3days, cyclophosphamide 750mg / m2 1days. Antiemetic and symptomatic treatment could be given during chemotherapy, and generally treated with other chemotherapy.
- Post-treatment assessment Subjects were assessed for toxicity as planned (weekly for 1 month, monthly for 6 months, and every 3 months thereafter); efficacy for every 4 weeks and every 3 months after 6 months. CAR-T cells were tested for in vivo expansion evaluation, including CD3 +, CD4 +, CD8 + T lymphocytes and B lymphocytes in peripheral blood.
- purpose of research
- Primary objective: To evaluate the effectiveness of APRIL-BAFF-Bicephali CAR-T in the treatment of relapsed and refractory multiple myeloma 2. Secondary objective: To evaluate its safety 3. Study design type, principles, and test procedures
- Conditions
- Multiple Myeloma
- Being tested
- APRIL-BAFF-Bicephali CAR-T cells
- Keywords
- myeloma, Chimeric antigen receptor, April, TACI
- Medical subject headings
- Multiple Myeloma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APRIL-BAFF-Bicephali CAR-T cellsOther
Peripheral blood mononuclear cells were collected and subjected to CD3+T cells were enriched, transfected with APRIL-BAFF-Bicephali lentiviral vector, expanded by in vitro culture, and pretreated with clear lymphocytes using the FC protocol before infusion of APRIL-BAFF-Bicephali CAR-T cells.
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with CAR T cells | Experimental | Peripheral blood mononuclear cells were collected and subjected to CD3+T cells were enriched, transfected with APRIL-BAFF-Bicephali lentiviral vector, expanded by in vitro culture, and pretreated with clear lymphocytes using the FC protocol before infusion of APRIL-BAFF-Bicephali CAR-T cells. Receives: Other: APRIL-BAFF-Bicephali CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Adverse events assessed according to NCI-CTCAE v5.0
Measured: :Baseline up to 28 days after CAR-T cells infusion]
Secondary outcomes (4)
overall response rate (ORR)
Assessment of ORR at Month 6, 12, 18 and 24
Measured: Month 6, 12, 18 and 24
complete response (CR)
Assessment of CR at Month 6, 12, 18 and 24
Measured: Month 6, 12, 18 and 24
Overall survival (OS)
Assessment of OS at Month 6, 12, 18 and 24
Measured: Month 6, 12, 18 and 24
Event-free survival (EFS)
Assessment of EFS at Month 6, 12, 18 and 24
Measured: Month 6, 12, 18 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start10 Nov 2023
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2027 (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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuzhou Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Yake Biotechnology Ltd.
- Responsible party
- Principal investigator, Kai Lin Xu，MD, Xuzhou Medical University
- Investigators
- Kailin Xu MD, PD, Study chair, The Affiliated Hospital oh Xuzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06132711
- Sponsor's protocol ID
- XYFY2023-KL144-01
- Acronym
- CAR-T
- Status last verified
- Nov 2023
- First submitted
- 11 Jul 2023
- Last updated
- 15 Nov 2023
- 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 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of APRIL-BAFF-Bicephali CAR-T in Relapsed, Refractory Multiple Myeloma-A Single-center, Open-label, Single-arm Clinical Study
- ClinicalTrials.gov ID
- NCT06132711
- Acronym / sponsor ID
- CAR-T / XYFY2023-KL144-01
- Conditions
- Multiple Myeloma
- Keywords
- myeloma, Chimeric antigen receptor, April, TACI
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Xuzhou Medical UniversityUniversity, hospital or other
- Collaborators
- Yake Biotechnology Ltd.
- Study start
- 10 Nov 2023 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 15 Nov 2023 (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-center, open, single-arm clinical study, the goal of which was to evaluate the safety and efficacy of APRIL-BAFF-Bicephali CAR-T in relapsed and refractory multiple myeloma.The study consisted of four processes: patient enrollment screening; pre-CAR T cell therapy (including leukocyte apheresis, CAR T cell preparation and chemotherapy); inpatient monitoring phase for CAR T cell transfusion; and long-term follow-up phase
Detailed description
This trial is a single-center, open, single-arm trial with a non-blinded design.
The study consisted of four processes: patient enrollment screening; pre-CAR T cell therapy (including leukocyte apheresis, CAR T cell preparation and chemotherapy); inpatient monitoring phase for CAR T cell transfusion; and long-term follow-up phase. The specific execution process is as follows:
- Pre-enrollment assessment;
- Patient enrollment and basic data collection;
- Leukocyte apheresis and CAR-T cell production 3.1 Patients receive apheresis of about 12-15 liters to provide peripheral blood mononuclear cells for the preparation of CAR-T. In addition to the use of appropriate amounts of lymphocytes for CAR-T preparation, excess cells should be cryopreserved for subsequent studies and regulatory inquiries. 3.2 APRIL-BAFF Bicephali CAR-T cell preparation. 4 cells were pretreated before transfusion Pretreatment was started-5 days before CAR-T cell revertant, and CAR-T cell treatment was performed 2 days after completion of chemotherapy. The purpose of chemotherapy is to reduce the tumor load on the one hand and to reduce the number of endogenous lymphocytes to facilitate the proliferation of reinfused CAR T cells. All patients were pretreated with FC regimen, fludarabine 30mg / m2 3days, cyclophosphamide 750mg / m2 1days. Antiemetic and symptomatic treatment could be given during chemotherapy, and generally treated with other chemotherapy.
- Post-treatment assessment Subjects were assessed for toxicity as planned (weekly for 1 month, monthly for 6 months, and every 3 months thereafter); efficacy for every 4 weeks and every 3 months after 6 months. CAR-T cells were tested for in vivo expansion evaluation, including CD3 +, CD4 +, CD8 + T lymphocytes and B lymphocytes in peripheral blood.
- purpose of research
- Primary objective: To evaluate the effectiveness of APRIL-BAFF-Bicephali CAR-T in the treatment of relapsed and refractory multiple myeloma 2. Secondary objective: To evaluate its safety 3. Study design type, principles, and test procedures
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated with CAR T cells | Experimental | Other: APRIL-BAFF-Bicephali CAR-T cellsPeripheral blood mononuclear cells were collected and subjected to CD3+T cells were enriched, transfected with APRIL-BAFF-Bicephali lentiviral vector, expanded by in vitro culture, and pretreated with clear lymphocytes using the FC protocol before infusion of APRIL-BAFF-Bicephali CAR-T cells. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- The set subject inclusion criteria include multiple documents of multiple myeloma, no effective treatment options (e. g. autologous or allogeneic stem cell transplantation) and limited outcome (<2 years) with existing therapies, as follows:
- Age is 18~70 years old;
- Expected survival period of>12 weeks;
- Multiple myeloma was diagnosed by physical examination, pathological examination, laboratory examination and imaging;
- Patients with refractory multiple myeloma;
Key exclusion criteria (10 listed)
- Women who are pregnant or breastfeeding, or who have a pregnancy plan within six months;
- Infectious diseases (such as HIV, active tuberculosis, etc.);
- Active hepatitis B or hepatitis C infection;
- Feasibility assessment screening demonstrated <10% transfection of targeted lymphocytes or underamplification under CD3 / CD28 co-stimulation (<5-fold);
- Abnormal vital signs, and unable to cooperate with the examination;
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 |
|---|---|---|
| APRIL-BAFF-Bicephali CAR-T cellsPeripheral blood mononuclear cells were collected and subjected to CD3+T cells were enriched, transfected with APRIL-BAFF-Bicephali lentiviral vector, expanded by in vitro culture, and pretreated with clear lymphocytes using the FC protocol before infusion of APRIL-BAFF-Bicephali CAR-T cells. | Other | Patients treated with CAR T cells |
Primary outcome
Adverse events
Time frame: :Baseline up to 28 days after CAR-T cells infusion]
Adverse events assessed according to NCI-CTCAE v5.0
4 secondary outcomes
overall response rate (ORR)
Time frame: Month 6, 12, 18 and 24
complete response (CR)
Time frame: Month 6, 12, 18 and 24
Overall survival (OS)
Time frame: Month 6, 12, 18 and 24
Event-free survival (EFS)
Time frame: Month 6, 12, 18 and 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
- 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.
Kailin Xu MD, PD study chair
The Affiliated Hospital oh Xuzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing APRIL-BAFF-Bicephali CAR-T cells in people with Multiple Myeloma, run by Xuzhou Medical 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 13 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 15 Nov 2023. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kailin Xu MD, PD (15162166166, lihmd@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: :Baseline up to 28 days after CAR-T cells 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 15 Nov 2023.