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

  • STATUS
    Recruiting
  • End date
    Dec 5, 2022
  • participants needed
    80
  • sponsor
    Chinese PLA General Hospital
Updated on 22 January 2021
refractory multiple myeloma
bcma

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.

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.
    3. 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.

Details
Condition Multiple Myeloma, Lymphoproliferative Disorder, Lymphoproliferative disorders, multiple myeloma (mm)
Treatment Dual Specificity CD38 and bcma CAR-T Cells
Clinical Study IdentifierNCT03767751
SponsorChinese PLA General Hospital
Last Modified on22 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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