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Trial record 23 of 34 for:    Han weidong

A Feasibility and Safety Study of Dual Specificity CD38 and BCMA CAR-T Cell Immunotherapy for Relapsed or Refractory Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT03767751
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
Han weidong, Chinese PLA General Hospital

Brief Summary:
CAR-T cell therapy has shown promising results for the treatment of relapsed or refractory Multiple Myeloma,however, a subset of patients relapse due to the loss of target in tumor cells.Dual Specificity CD38 and BCMA CAR-T cells can recognize and kill the malignant cells through recognition of CD38 or BCMA. This is a phase 1/2 study designed to determine the safety of dual specificity CD38 and BCMA CAR-T cells and the feasibility of making enough to treat patients with relapsed or refractory Multiple Myeloma.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Biological: Dual Specificity CD38 and bcma CAR-T Cells Phase 1 Phase 2

Detailed Description:
  1. PRIMARY OBJECTIVES:

    1. To evaluate the feasibility and safety of dual specificity CD38 and BCMA CAR-T cells in patients with relapsed or refractory Multiple Myeloma.
    2. To evaluate the duration of in vivo persistence of adoptively transferred T cells, and the phenotype of persisting T cells.Real Time polymerase chain receptor (RT-PCR) and Flow cytometry(FCM) analysis of PB,BM and lymph node will be used to detect and quantify survival of universal dual specificity CD38 and BCMA CAR-T cells over time.
  2. SECONDARY OBJECTIVES:

1.For patients with detectable disease, measure anti-tumor response due to dual specificity CD38 and BCMA CAR-T cell infusions.

2.The CAR-T cells will be administered by i.v. injection over 20-30 minutes as a using Day 0: 1-5x10e6/kg total dose on day 0.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Study to Evaluate Treatment of Relapsed or Refractory Multiple Myeloma With Dual CAR-T Cells Targeting CD38 and BCMA
Actual Study Start Date : December 5, 2018
Estimated Primary Completion Date : December 5, 2022
Estimated Study Completion Date : December 5, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma


Intervention Details:
  • Biological: Dual Specificity CD38 and bcma CAR-T Cells
    1) Biological: Dual Specificity CD38 and BCMA CAR-T Cells,2)1-5X10E6/Kg


Primary Outcome Measures :
  1. Number of Participants with Severe/Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 24weeks ]
  2. MTD of dual specificity CD38 and BCMA CAR-T cells [ Time Frame: 4 weeks ]
    The highest dose of dual specificity CD38 and BCMA CAR-T cells that is estimated to result in defined Dose Limiting Toxicity (DLT) with the exception of allowable 'expected' AEs associated with the intravenous infusion of dual specificity CD38 and BCMA CAR-T cells

  3. Copies numbers of CAR in peripheral blood(PB), bone marrow(BM)and lymph nodes [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Six-month Objective response rate of complete remission and partial remission [ Time Frame: 24 weeks ]
  2. Six-month Overall survival [ Time Frame: 24 weeks ]
  3. Six-month Progression free survival [ Time Frame: 24 weeks ]


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Ages Eligible for Study:   12 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female participant
  2. 12 Years to 70 Years (Child, Adult, Senior)
  3. Patient with relapsed or refractory Multiple Myeloma,multiple myeloma cell express CD38(over 50%) and BCMA (over 50%)
  4. Estimated life expectancy ≥ 12 weeks (according to investigator's judgement)
  5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
  6. Adequate organ function

Exclusion Criteria:

  1. Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and with no evidence of active disease
  2. Diagnosis of Burkitt's leukemia/lymphoma according to WHO classification or chronic myelogenous leukemia lymphoid blast crisis
  3. Richter's syndrome
  4. Presence of Grade II-IV (Glucksberg) or B-D (IBMTR) acute or extensive chronic GVHD at the time of screening
  5. Subjects with any autoimmune disease or any immune deficiency disease or other disease in need of immunosuppressive therapy
  6. Severe active infection (uncomplicated urinary tract infections, bacterial pharyngitis is allowed), Prophylactic antibiotic, antiviral and antifungal treatment is permissible
  7. Active hepatitis B, active hepatitis C, or any human immunodeficiency virus (HIV) infection at the time of screening
  8. Patient has an investigational medicinal product within the last 30 days prior to screening
  9. Previous treatment with investigational gene or cell therapy medicine products
  10. Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary
  11. Pregnant or nursing women

Information from the National Library of Medicine

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): NCT03767751


Contacts
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Contact: YaJing Zhang 86-10-55499341 plagh@qq.com

Locations
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China
Biotherapeutic Department and Hematology Department of Chinese PLA General Hospital Recruiting
Beijing, China, 100853
Contact: Weidong Han    86-10-13651392893    hanwdrsw@sina.com   
Sponsors and Collaborators
Chinese PLA General Hospital

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Responsible Party: Han weidong, Director of Molecular & Immunological Department,Biotherapeutic Department, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT03767751     History of Changes
Other Study ID Numbers: CHN-PLAGH-BT-037
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases