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Trial record 27 of 34 for:    Han weidong

A Feasibility and Safety Study of Concomitant Therapy With Allo-CAR-T Cells and Allo-HSCT in Patients With Relapse or Refractory Leukemia

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ClinicalTrials.gov Identifier: NCT03463928
Recruitment Status : Recruiting
First Posted : March 13, 2018
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
Han weidong, Chinese PLA General Hospital

Brief Summary:
Allogenic hematopoietic stem cell transplant (Allo-HSCT) is routinely used for treatment of aggressive hematological malignancies. The biological foundation of allo-HSCT is the graft-versus-leukemia (GVL) effect, which is primarily mediated by donor T cells present in the graft and is able to eradicate malignant B cells either CD19+ or CD19-. Relapse following an allo-HSCT remains a major challenge in the treatment of B-ALL. CD19-directed CAR-T cell therapy has shown promising results for the treatment of relapsed or refractory B-cell malignancies; however, a subset of patients relapse due to the loss of CD19 in tumor cells. Co-infusion of donor-derived CD19/22 bispecific CAR-T cells or CD19-directed CAR-T cells and donor-derived-HSCT has the potential to combine the CAR-T cell mediated targeted elimination of CD19 expressing B cells with GVL effect, which could have clear advantages in reducing the risk of relapse and the evolution of CD19− escape variants or clonally related malignancies in other lineages. Therefore, a complete and durable tumor responses induced by this immunotherapy could be expected.

Condition or disease Intervention/treatment Phase
B Cell Leukemia Biological: donor-derived CD19/22 bispecific CAR-T cells or CD19-directed CAR-T cells; donor-derived-HSCT Phase 1

Detailed Description:
  1. PRIMARY OBJECTIVES:

    1. To evaluate the feasibility and safety of donor-derived HSCT following donor-derived CD19/22 bispecific CAR-T cells or CD19-directed CAR-T cells in patients with relapsed or refractory leukemia.
    2. To evaluate the duration of in vivo persistence of adoptively transferred CAR-T cells, and the phenotype of persisting T cells. Real Time polymerase chain receptor (RT-PCR) and Flow cytometry(FCM) analysis of PB,BM will be used to detect and quantify survival of infused allo-CAR-T cells over time.
    3. To evaluate the donor chimerism after co-infusion of donor-derived CD19/22 bispecific CAR-T cells or CD19-directed CAR-T cells and donor-derived-HSCT
  2. SECONDARY OBJECTIVES:

    1. For patients with detectable disease, measure anti-tumor response due to co-infusion of donor-derived CD19/22 bispecific CAR-T cells or CD19-directed CAR-T cells and donor-derived-HSCT.

The allo-CAR-T cells will be infused in a fractionated manner, 1/3 on day 0, 2/3 on day 1.The allo-HSCT will be infused on day 2.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study to Evaluate Treatment of Relapsed or Refractory Leukemia With Donor-derived HSCT Following Donor-derived CD19/22 Bispecific CAR-T Cells or CD19-directed CAR-T Cells
Actual Study Start Date : October 8, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia


Intervention Details:
  • Biological: donor-derived CD19/22 bispecific CAR-T cells or CD19-directed CAR-T cells; donor-derived-HSCT
    The allo-CAR-T cells will be infused in a fractionated manner, 1/3 on day 0, 2/3 on day 1.The allo-HSCT will be infused on day 2.


Primary Outcome Measures :
  1. Number of Participants with Severe/Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Overall remission rate (ORR) = CR + CRi [ Time Frame: 24 weeks ]
  2. Six-month Overall survival [ Time Frame: 24 weeks ]
  3. Six-month Progression free survival [ Time Frame: 24 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female participant
  2. 12 Years to 60 Years
  3. Patient with relapsed or refractory B-cell leukemia or lymphoma
  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): NCT03463928


Contacts
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Contact: Hejin Jia 86-10-55499341 jiahejin@163.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, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT03463928     History of Changes
Other Study ID Numbers: CHN-PLAGH-BT-027
First Posted: March 13, 2018    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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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Leukemia
Leukemia, B-Cell
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Leukemia, Lymphoid
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases