AHSCT Combined With CAR-T Cells in the Treatment of Refractory and Relapsed Multiple Myeloma

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	30 Years - 75 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- 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.

- 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:

- 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; - 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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05740891
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Zhejiang University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	He Huang, MD
Principal Investigator Affiliation	First Affiliated Hospital of Zhejiang University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, Industry
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Multiple Myeloma

Additional Details

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.

Arms & Interventions

Arms

Experimental: Treatment Group

Refractory and relapsed multiple myeloma

Interventions

Drug: - BCMA CAR-T cells injection

Autologous hematopoietic stem cell transplantation combined with BCMA CAR-T cells

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Hangzhou, Zhejiang, China

Status

Recruiting

Address

The first affiliated hospital of medical college of zhejiang university

Hangzhou, Zhejiang, 310003

Site Contact

He Huang, MD

hehuangyu@126.com

86-13605714822

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