Study of T Cells Targeting CD138/BCMA/CD19/More Antigens (CART-138/BCMA/19/More) for Chemotherapy Refractory and Relapsed Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT03196414|
Recruitment Status : Recruiting
First Posted : June 22, 2017
Last Update Posted : May 2, 2019
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|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Biological: CART-138/BCMA/19/more||Phase 1 Phase 2|
Adults ages 18-75 with Relapsed and/or Chemotherapy Refractory Multiple Myelomas.
Participants may be screened with:
Medical history Physical exam Blood and urine tests Heart tests Bone marrow sample Multiple scans and X-rays Lymphocytes are collected by apheresis from the enrolled patient or a healthy donor. Blood is removed through a needle in an arm. The rest of the blood is returned through a needle in the other arm.
The cells will be changed in a laboratory. Participants will get 2 chemotherapy drugs over 5 days. Two days later, participants will get an intravenous (IV) catheter in an arm. They will get the split doses CART cells on day0, day1, day2 through the IV in 1 infusion.
After this, participants will stay in the hospital for at least 9 days and stay nearby for 2 weeks. Then they will have blood tests and see a doctor.
Participants will visit the clinic at 1, 2, 3, 6, 9 and 12 months after the infusion, then every 6 months until two years after infusion. A bone marrow sample will be taken at the 3-month visit.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study of T Cells Targeting CD138/BCMA/CD19/More Antigens (CART-138/BCMA/19/More) for Chemotherapy Refractory and Relapsed Multiple Myeloma|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||September 2026|
|Estimated Study Completion Date :||December 2026|
Cyclophosphamide，Fludarabine，CART-138/BCMA /19/more cells Cyclophosphamide: 300 mg/m2 IV over 30 minutes on days -5 , -4,and -3; Fludarabine: 30 mg/m2 IV over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3 Biological: Anti-CD138/BCMA/CD19/more total CART cells 5x106- 100x106 CAR+ T cells per kg of recipient bodyweight
- Determine if there is grade 3 to 5 cytokine release syndrome [ Time Frame: 2 weeks-12 months after initial dose ]Number of Patients With Grade 3 Through Grade 5 Cytokine Release Syndrome(CRS) That Are Related to Study Intervening Measures, Graded According to NCI CTCAE Version 4.0
- Investigators try to assess major reaction rate (MRR, PR+VGPR+CR) at the end of the research. [ Time Frame: up to 24 weeks ]Number of Patients achieved major reaction rate (MRR;PR+VGPR+CR) According to IMWG response criteria at the end of the research.
- Investigators try to test CART 138 cells copies in vivo. [ Time Frame: 2 years ]CART Cell survival time by testing CART-138/BCMA cells copies in vivo through PCR Method.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- CD138 or BCMA antigen positive multiple myeloma in patients with no available curative treatment options (such as autologous or allogeneic SCT).
- Relapsed and/or refractory multiple myeloma.
- Relapsed after prior autologous or allogenic SCT.
- Expected survival ≥ 3 months
- Creatinine < 2.0 mg/dl
- Blood coagulation function: PT and APTT < 2x normal
- Arterial blood oxygen saturation > 92%
- Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) < 3x normal
- Karnofsky scores ≥ 60 and ECOG score ≤ 2
- Adequate venous access for apheresis, and no other contraindications for leukapheresis
- Patients should not take system chemotherapy in one month and immunotherapy in three months prior to CART cells infusion.
- Voluntary informed consent is given
- Pregnant or lactating women
- Uncontrolled active infection.
- Active hepatitis B or hepatitis C infection.
- Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
- Previously treatment with any gene therapy products
- Any uncontrolled active medical disorder that would preclude participation as outlined.
- HIV infection.
- History of myocardial infarction and severe arrhythmia in half a year
- Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).
- Patients with fever of unknown origin (T > 38℃)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03196414
|Contact: Ling zhi Yan, PhDemail@example.com|
|First Affiliated Hospital, Soochow University||Recruiting|
|Suzhou, Jiangsu, China, 215000|
|Contact: Ling zhi Yan, Phd 13584821140 firstname.lastname@example.org|
|Principal Investigator:||Fu cheng cheng, PhD||First Affiliated Hospital,Soochow University|
|Responsible Party:||The First Affiliated Hospital of Soochow University|
|Other Study ID Numbers:||
|First Posted:||June 22, 2017 Key Record Dates|
|Last Update Posted:||May 2, 2019|
|Last Verified:||September 2016|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Blood Protein Disorders
Immune System Diseases