Multiple MyelomaPhase 1NCT05740891
AHSCT Combined With CAR-T Cells in the Treatment of Refractory and Relapsed Multiple Myeloma
A Phase 1 study testing BCMA CAR-T cells injection in people with Multiple Myeloma, run by Zhejiang University at 1 site in China.
Trial summary
Clinical Study on the Safety and Effectiveness of Autologous Hematopoietic Stem Cell Transplantation Combined With CAR-T Cells in the Treatment of Refractory and Relapsed Multiple Myeloma Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- BCMA CAR-T cells injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Mar 2023to Mar 2025
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1、BCMA positive accompanied by refractory/relapsed and resistance;
- 2、Patients with the tumor load is high and cannot be transplanted directly, before transplantation. Reduce the load through CAR-T treatment to prepare for transplantation;
- 3、Patient relapses after transplantation,donor lymphocyte infusion Invalid. The donor cells in the recipient body can be used or the donor cells can be collected directly.Prepare CAR-T to prevent recurrence and induce relapsing;
- 4、Repeated MRD (+) refractory drug resistant cases;
- 5、Male or female, 30-75 years old;
- 6、Anticipated survival time more than 12 weeks
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- 7、Transplant subjects, regardless of their previous treatment, are eligible for inclusion after relapse；
- 8、Patients had a negative urine pregnancy test before the start of administration and agreed to take effective contraceptive measures during the test period until the last follow-up;
- 9、Those who voluntarily participate in the trial and sign the informed consent form
Who cannot join
- 1、Patients with the history of epilepsy or other CNS disease；
- 2、Patients with prolonged QT interval time or severe heart disease；
- 3、Pregnant or breastfeeding;
- 4、Active infection with no cure;
- 5、Patients with active hepatitis B or C infection;
- 6、Previously treated with any genetic therapy;
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- 7、The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
- 8、Serum creatinine > 2.5mg/dl or ALT / AST > 3 times ULN or bilirubin > 2.0mg/dl;
- 9、Those who suffer from other uncontrolled diseases are not suitable to join the study;
- 10、HIV infection;
- 11、Any situation that the researchers believe may increase the risk of patients or interfere with the test results.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang, 310003
He Huang, MD, 86-13605714822, hehuangyu@126.com
Yongxian Hu, MD, +8615957162012, huyongxian2000@aliyun.com
About this study
Official title: Clinical Study on the Safety and Effectiveness of Autologous Hematopoietic Stem Cell Transplantation Combined With CAR-T Cells in the Treatment of Refractory and Relapsed Multiple Myeloma
Clinical Study on the Safety and Effectiveness of Autologous Hematopoietic Stem Cell Transplantation Combined With CAR-T Cells in the Treatment of Refractory and Relapsed Multiple Myeloma
Read the detailed description
This is a prospectiv , single arm, open-label, single-center study. This study is indicated for refractory and relapsed multiple myeloma. It aims to evaluate the safety and effectiveness of autologous hematopoietic stem cell transplantation combined with BCMA CAR-T to treat refractory and relapsed multiple myeloma. The main research is completely alleviated, overall reaction rate, and recurrence rate,etc. 50 patients will be enrolled.
- Conditions
- Multiple Myeloma
- Being tested
- BCMA CAR-T cells injection
- Keywords
- AHSCT, BCMA CAR-T
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCMA CAR-T cells injectionDrug
Autologous hematopoietic stem cell transplantation combined with BCMA CAR-T cells
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Refractory and relapsed multiple myeloma Receives: Drug: BCMA CAR-T cells injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT)
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Measured: Baseline up to 28 days after BCMA CAR T-cells infusion
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of treatment-emergent adverse events [Safety and Tolerability]
Measured: 24 months after cell infusion
Secondary outcomes (5)
overall response rate
The number of response patients/the number of total patients
Measured: Up to 30 months
Complete response rate(CRR)
Proportion of subjects who achieved morphological complete response (CR) and complete response with hematologic incomplete recovery (CRi)
Measured: Baseline up to 2 years after BCMA CAR T-cells infusion
Overall survival (OS)
Assessment of OS at Month 6,12,18and 24
Measured: Month 6,12,18and 24
Duration of response(DOR)
Assessment of OS at Month 6,12,18and 24
Measured: Month 6,12,18and 24
Progression-free survival (PFS)
Assessment of PFS at Month 6,12,18and 24
Measured: Month 6,12,18and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study startMar 2023 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (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.
- More trials run by Zhejiang UniversityThe 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Yake Biotechnology Ltd.
- Responsible party
- Principal investigator, He Huang, Zhejiang University
- Investigators
- He Huang, MD, Principal investigator, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05740891
- Sponsor's protocol ID
- IIT20210027C-R3
- Status last verified
- Feb 2023
- First submitted
- 3 Feb 2023
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Safety and Effectiveness of Autologous Hematopoietic Stem Cell Transplantation Combined With CAR-T Cells in the Treatment of Refractory and Relapsed Multiple Myeloma
- ClinicalTrials.gov ID
- NCT05740891
- Acronym / sponsor ID
- IIT20210027C-R3
- Conditions
- Multiple Myeloma
- Keywords
- AHSCT, BCMA CAR-T
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Yake Biotechnology Ltd.
- Study start
- Mar 2023 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 23 Feb 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.
Clinical Study on the Safety and Effectiveness of Autologous Hematopoietic Stem Cell Transplantation Combined With CAR-T Cells in the Treatment of Refractory and Relapsed Multiple Myeloma
Detailed description
This is a prospectiv , single arm, open-label, single-center study. This study is indicated for refractory and relapsed multiple myeloma. It aims to evaluate the safety and effectiveness of autologous hematopoietic stem cell transplantation combined with BCMA CAR-T to treat refractory and relapsed multiple myeloma. The main research is completely alleviated, overall reaction rate, and recurrence rate,etc. 50 patients will be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Drug: BCMA CAR-T cells injectionRefractory and relapsed multiple myeloma |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 1、BCMA positive accompanied by refractory/relapsed and resistance;
- 2、Patients with the tumor load is high and cannot be transplanted directly, before transplantation. Reduce the load through CAR-T treatment to prepare for transplantation;
- 3、Patient relapses after transplantation,donor lymphocyte infusion Invalid. The donor cells in the recipient body can be used or the donor cells can be collected directly.Prepare CAR-T to prevent recurrence and induce relapsing;
- 4、Repeated MRD (+) refractory drug resistant cases;
- 5、Male or female, 30-75 years old;
Key exclusion criteria (11 listed)
- 1、Patients with the history of epilepsy or other CNS disease；
- 2、Patients with prolonged QT interval time or severe heart disease；
- 3、Pregnant or breastfeeding;
- 4、Active infection with no cure;
- 5、Patients with active hepatitis B or C infection;
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 |
|---|---|---|
| BCMA CAR-T cells injectionAutologous hematopoietic stem cell transplantation combined with BCMA CAR-T cells | Drug | Treatment Group |
Primary outcome
Dose-limiting toxicity (DLT)
Time frame: Baseline up to 28 days after BCMA CAR T-cells infusion
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: 24 months after cell infusion
Incidence of treatment-emergent adverse events [Safety and Tolerability]
5 secondary outcomes
overall response rate
Time frame: Up to 30 months
Complete response rate(CRR)
Time frame: Baseline up to 2 years after BCMA CAR T-cells infusion
Overall survival (OS)
Time frame: Month 6,12,18and 24
Duration of response(DOR)
Time frame: Month 6,12,18and 24
Progression-free survival (PFS)
Time frame: Month 6,12,18and 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
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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.
He Huang, MD principal investigator
First Affiliated Hospital of Zhejiang 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 study testing BCMA CAR-T cells injection in people with Multiple Myeloma, run by Zhejiang 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 9 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 23 Feb 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 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 He Huang, MD (+8613605714822, hehuangyu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (DLT) (time frame: Baseline up to 28 days after BCMA CAR T-cells infusion). 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 23 Feb 2023.