AHSCT Combined With CAR-T Cells in the Treatment of Refractory and Relapsed Multiple Myeloma
NCT ID: NCT05740891
Last Updated: 2023-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
50 participants
INTERVENTIONAL
2023-03-31
2025-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment Group
Refractory and relapsed multiple myeloma
BCMA CAR-T cells injection
Autologous hematopoietic stem cell transplantation combined with BCMA CAR-T cells
Interventions
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BCMA CAR-T cells injection
Autologous hematopoietic stem cell transplantation combined with BCMA CAR-T cells
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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;
* 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.
30 Years
75 Years
ALL
No
Sponsors
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Yake Biotechnology Ltd.
INDUSTRY
Zhejiang University
OTHER
Responsible Party
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He Huang
The President of The First Affiliated Hospital, College of Medicine, Zhejiang University
Principal Investigators
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He Huang, MD
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital of Zhejiang University
Locations
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The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IIT20210027C-R3
Identifier Type: -
Identifier Source: org_study_id
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