Multiple MyelomaPhase 1/2NCT06196255
Safety and Efficacy of Anti-FcRL5 CAR-T Cell Therapy in Treating Relapsed and Refractory Multiple Myeloma (R/R MM)
A Phase 1/2 study testing anti-FcRL5 CAR-T in people with Multiple Myeloma, run by Xuzhou Medical University at 1 site in China.
Trial summary
This is an open label, single-arm, Phase 2 study to evaluate the efficacy and safety of Anti-FcRL5 CAR-T in subjects with relapsed and refractory multiple myeloma. A leukapheresis procedure will be performed to manufacture. Anti-FcRL5 chimeric antigen receptor (CAR) modified 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?
- anti-FcRL5 CAR-T
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 25 Dec 2023to 1 Jan 2028
- 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 costimulation (<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
The affiliated hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221006
Kailin Xu, MD, 15162166166, lihmd@163.com
About this study
Official title: Efficacy and Safety Study of Anti-FcRL5 CAR-T Cells in Subjects With Relapsed and Refractory Multiple Myeloma
This is an open label, single-arm, Phase 2 study to evaluate the efficacy and safety of Anti-FcRL5 CAR-T in subjects with relapsed and refractory multiple myeloma. A leukapheresis procedure will be performed to manufacture. Anti-FcRL5 chimeric antigen receptor (CAR) modified T cells. Prior to Anti-FcRL5 infusion subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide.
Read the detailed description
This open label, single-arm, Phase 2 study aims to evaluate the efficacy and safety of Anti-FcRL5 CAR-T in subjects with relapsed and refractory multiple myeloma. A leukapheresis procedure will be performed to manufacture. Anti-FcRL5 chimeric antigen receptor (CAR) modified T cells. Prior to Anti-FcRL5 infusion subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide. After infusion, the investigators will observe the characteristics of dose limited toxicity (DLT), and determine the maximum tolerable agent MTD and rp2d were confirmed. To provide basis for the dosage and treatment plan of cell products in follow-up clinical trials.
- Conditions
- Multiple Myeloma
- Being tested
- anti-FcRL5 CAR-T
- Keywords
- Multiple Myeloma, FcRL5
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-FcRL5 CAR-TDrug
anti-FcRL5 autologous CAR T cells will be infused at a dose ranging from 1 - 2 x 10^6/kg CAR+ T cells after receiving lymphodepleting chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| anti FcRL5 CAR-T | Experimental | anti-FcRL5 autologous CAR T cells will be infused at a dose ranging from 1 - 2 x 10^6/kg CAR+ T cells after receiving lymphodepleting chemotherapy. Receives: Drug: anti-FcRL5 CAR-T |
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 posted9 Jan 2024
- Study start25 Dec 2023
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2028 (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
- 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
- NCT06196255
- Sponsor's protocol ID
- XYFY2023-KL216-01
- Status last verified
- Dec 2023
- First submitted
- 25 Dec 2023
- Last updated
- 9 Jan 2024
- Results posted
- 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 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Study of Anti-FcRL5 CAR-T Cells in Subjects With Relapsed and Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT06196255
- Acronym / sponsor ID
- XYFY2023-KL216-01
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, FcRL5
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Xuzhou Medical UniversityUniversity, hospital or other
- Study start
- 25 Dec 2023 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 9 Jan 2024 (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 an open label, single-arm, Phase 2 study to evaluate the efficacy and safety of Anti-FcRL5 CAR-T in subjects with relapsed and refractory multiple myeloma. A leukapheresis procedure will be performed to manufacture. Anti-FcRL5 chimeric antigen receptor (CAR) modified T cells. Prior to Anti-FcRL5 infusion subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide.
Detailed description
This open label, single-arm, Phase 2 study aims to evaluate the efficacy and safety of Anti-FcRL5 CAR-T in subjects with relapsed and refractory multiple myeloma. A leukapheresis procedure will be performed to manufacture. Anti-FcRL5 chimeric antigen receptor (CAR) modified T cells. Prior to Anti-FcRL5 infusion subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide. After infusion, the investigators will observe the characteristics of dose limited toxicity (DLT), and determine the maximum tolerable agent MTD and rp2d were confirmed. To provide basis for the dosage and treatment plan of cell products in follow-up clinical trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| anti FcRL5 CAR-T | Experimental | Drug: anti-FcRL5 CAR-Tanti-FcRL5 autologous CAR T cells will be infused at a dose ranging from 1 - 2 x 10^6/kg CAR+ T cells after receiving lymphodepleting chemotherapy. |
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 costimulation (<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 |
|---|---|---|
| anti-FcRL5 CAR-Tanti-FcRL5 autologous CAR T cells will be infused at a dose ranging from 1 - 2 x 10^6/kg CAR+ T cells after receiving lymphodepleting chemotherapy. | Drug | anti FcRL5 CAR-T |
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 9 Jan 2024.
- 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 anti-FcRL5 CAR-T 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 9 Jan 2024. 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 ext. PD, 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 9 Jan 2024.