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Trial record 1 of 1 for:    PLAT-03 | Recruiting, Not yet recruiting Studies
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Pilot Study of T-APCs Following CAR T Cell Immunotherapy for CD19+ Leukemia

This study is currently recruiting participants.
Verified August 2017 by Rebecca Gardner, Seattle Children's Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT03186118
First Posted: June 14, 2017
Last Update Posted: August 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Rebecca Gardner, Seattle Children's Hospital
  Purpose

This study will enroll patients who have been enrolled into study PLAT-02 and meet the entry criteria for study PLAT-03.

Patients with relapsed or refractory CD 19+ leukemia who have achieved remission after CD19 CAR-T cell treatment sometimes relapse because the CD 19 CAR-T cells decrease in number over time. Study PLAT-03 will test whether administering T cell antigen presenting cells (T-APCs) at intervals following treatment with CAR-T cells improves CD 19 CAR-T cell persistence and reduces the incidence of leukemia relapse.


Condition Intervention Phase
CD 19+ Acute Leukemia Biological: T-cell Antigen Presenting Cells expressing truncated CD19 (T-APC) Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Subjects are assessed during the parent study for total CD 19 load in bone marrow. Participants meeting eligibility criteria are transitioned into one of 3 arms in PLAT-03.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Feasibility and Safety Study of CD19t T-Antigen Presenting Cells (T-APCs) Following CAR T Cell Immunotherapy for CD19+ Leukemia

Resource links provided by NLM:


Further study details as provided by Rebecca Gardner, Seattle Children's Hospital:

Primary Outcome Measures:
  • The adverse events associated with one or multiple CD19t T-APC product infusions will be assessed. [ Time Frame: up to 6 months ]
    Type, frequency, severity, and duration of adverse events will be summarized

  • Determine the feasibility of deriving and administering a CD19t T-APC product [ Time Frame: 28 days ]
    Proportion of products successfully manufactured and infused


Secondary Outcome Measures:
  • Quantification of changes in the number of CAR T cells in peripheral blood before and after receiving CD19t T-APCs [ Time Frame: 28 days ]
    Multiparameter Flow Cytometry (MPF) from peripheral blood as a measure of magnitude and presence of CAR T cells before and after a dose of T-APCs

  • Duration of B cell aplasia in CD19t T-APC treated patients [ Time Frame: up to 5 years ]
    MPF from peripheral blood as a measure of B cell aplasia


Estimated Enrollment: 30
Actual Study Start Date: August 4, 2017
Estimated Study Completion Date: July 2032
Estimated Primary Completion Date: August 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort A
Participants in PLAT-02 who are eligible for, and consent to, PLAT-03 Cohort A may transition to PLAT-03 to receive their initial infusion of CAR-T cells, followed by up to 6 T-APC treatments.
Biological: T-cell Antigen Presenting Cells expressing truncated CD19 (T-APC)
Autologous CD4 and CD8 T cells transduced to express a truncated CD19 (CD19t) Transgene
Other Name: CD19+ Chimeric Antigen Receptor T-cells (CAR-T cells)
Experimental: Cohort B
Participants in PLAT-02 who are eligible for, and consent to, PLAT-03 Cohort B may transition to PLAT-03 after their initial infusion of CAR-T cells and laboratory testing on study day 14 indicates that the are at risk for early loss of CAR T cells. Up to 6 T-APC treatments will be administered to participants. If further laboratory testing prior to planned T-APC treatment indicates loss of CAR-T cells, participants may move to Cohort C.
Biological: T-cell Antigen Presenting Cells expressing truncated CD19 (T-APC)
Autologous CD4 and CD8 T cells transduced to express a truncated CD19 (CD19t) Transgene
Other Name: CD19+ Chimeric Antigen Receptor T-cells (CAR-T cells)
Experimental: Cohort C
Participants in PLAT-02 who are eligible for, and consent to, PLAT-03 Cohort C may transition to PLAT-03 after their initial infusion of CAR-T cells and laboratory testing shows early loss of CAR T cells between day 63 and day 183. Participants will receive another CAR-T cell infusion followed by up to 6 T-APC treatments.
Biological: T-cell Antigen Presenting Cells expressing truncated CD19 (T-APC)
Autologous CD4 and CD8 T cells transduced to express a truncated CD19 (CD19t) Transgene
Other Name: CD19+ Chimeric Antigen Receptor T-cells (CAR-T cells)

Detailed Description:
This pilot study seeks to examine the feasibility and safety of administering T cell antigen presenting cells (T-APCs) designed to reactivate and numerically expand CD19-specific CAR T cells. The underlying hypothesis to be examined is that after remission is achieved with CAR T cell treatment, the duration, magnitude, and activation state of persisting memory CAR T cells impact on the potential for durable leukemia eradication. This is of particular relevance in several groups of patients we have identified: those who are predicted to lose persistence of their CAR T cells before Day 63, or those who have definitively lost persistence of CAR T cells prior to 6 months. By providing these patients with episodic exposure to T-APCs capable of activating CD19-specific CAR T cells for proliferation and redistribution to tissue beds where tumor cells of ALL seed, ideally over several months following remission induction, it is posited that the incidence of disease relapse will be diminished.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 26 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Previous treatment under protocol PLAT-02
  • Adequate performance status
  • Adequate renal, liver, cardiac, and respiratory function
  • Adequate absolute lymphocyte count
  • HIV negative; Hepatitis B and C negative within 3 months prior to enrollment.
  • Patient has sufficient stored T cell product to manufacture appropriate doses of T-APCs

Exclusion Criteria:

  • Evidence of active clinically significant CNS dysfunction
  • Evidence of active malignancy other than CD19+ malignancy
  • Evidence of active GVHD, or on immunosuppressive GVHD therapy within 4 weeks prior to enrollment
  Contacts and Locations
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): NCT03186118


Contacts
Contact: Heidi Ullom, RN 206-987-2553 immunotherapy@seattlechildrens.org

Locations
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Principal Investigator: Colleen Annesley, MD         
Sponsors and Collaborators
Seattle Children's Hospital
Investigators
Study Chair: Colleen Annesley, MD Seattle Children's Hospital
  More Information

Responsible Party: Rebecca Gardner, Assistant Professor, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT03186118     History of Changes
Other Study ID Numbers: PLAT-03
First Submitted: June 12, 2017
First Posted: June 14, 2017
Last Update Posted: August 7, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rebecca Gardner, Seattle Children's Hospital:
pediatric
young adult
acute lymphoblastic leukemia
CD 19
leukemia
chimeric antigen receptor
T cell

Additional relevant MeSH terms:
Leukemia
Neoplasms by Histologic Type
Neoplasms