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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03579888
Other study ID # 2019-1063
Secondary ID NCI-2020-0360820
Status Terminated
Phase Phase 1
First received
Last updated
Start date June 26, 2020
Est. completion date May 27, 2021

Study information

Verified date May 2021
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase I trial investigates the side effects and best dose of CD19 positive (+) specific CAR-T cells in treating patients with CD19+ lymphoid malignancies, such as acute lymphoblastic leukemia, non-Hodgkin lymphoma, small lymphocytic lymphoma, or chronic lymphocytic lymphoma. Sometimes researchers change the genetic material in the cells of a patient's T cells using a process called gene transfer. Researchers then inject the changed T-cells into the patient's body. Receiving the T-cell infusion may help to control the disease.


Description:

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Study Design


Related Conditions & MeSH terms

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Intervention

Biological:
Autologous CD19-CD8-CD28-CD3zeta-CAR-mbIL15-HER1t T Cells
Given IV
Drug:
Cyclophosphamide
Given IV
Fludarabine
Given IV

Locations

Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center Ziopharm Oncology

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of adverse events Graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Adverse events will be summarized by frequencies and percentages by dose level. Up to 15 years
Primary Maximum tolerated dose (MTD) as determined by dose limiting toxicity (DLT) The MTD is defined as the highest dose at which no more than 1 of 6 patients experiences a DLT. The study will employ a standard 3+3 design to find the MTD of CD19-specific chimeric antigen receptor (CAR) T cell dose. Up to 30 days post-infusion
Secondary Incidence and grading of cytokine release syndrome (CRS) Graded according to CTCAE. Up to 12 months
Secondary Persistence of genetically modified T cells Persistence of genetically modified T cells will be assessed by the frequency of patients with any detectable CAR-T cells. Up to 12 months
Secondary Change in numbers of infused T cells For patients receiving cetuximab (i.e., those who experience >= grade 3 CRS), the change in infused CAR+ T cells from before cetuximab treatment to the nadir of CAR+ T cells after cetuximab summarized by mean, standard deviation, median, and range and days to achieve nadir. Up to 12 months
Secondary Development of host immune responses against transgenes The development of host immune responses against the transgenes (one or more of CAR, mbIL15, HER1t) may be assessed by the percentage of patients with antibody formation against each one of the transgenes. Up to 12 months
Secondary Cytokine levels Individual patient and aggregate cytokine levels (e.g., IL-15, IL-12, IL-8, etc.) will be summarized by means, standard deviations, medians, and ranges. Up to 12 months
Secondary Homing ability of the infused T cells Homing will be assessed based on presence of infused T cells within biopsied tissue. The frequency and percentage of patients experiencing homing and those who have CD19- malignant B cells will be presented. Up to 12 months
Secondary Disease response Percentage of patients experiencing disease response, defined as partial or complete clearance of disease e.g., by positron emission tomography (PET) and/or bone marrow report will be computed along with a corresponding 95% confidence interval. The percentage of patients who had T cells successfully prepared, released, and infused will be reported. Additional statistical analyses will be performed if deemed appropriate. At days 30 and 100
Secondary Neurotoxicity Graded according to CTCAE. Up to 12 months
Secondary Presence of CD19 negative (-) malignant B cells Presence of CD19- malignant B cells will be based on flow cytometry staining for CD19 in the context of staining for antigens to detect cancerous B cells. The frequency and percentage of patients experiencing homing and those who have CD19- malignant B cells will be presented. Up to 12 months
Secondary Progression-free survival Will be estimated using the Kaplan-Meier method and presented along with their 95% confidence intervals. Additional statistical analyses will be performed if deemed appropriate. From the time of T-cell infusion to date of progression of date of death, assessed up to 12 months
Secondary Overall survival Will be estimated using the Kaplan-Meier method and presented along with their 95% confidence intervals. Additional statistical analyses will be performed if deemed appropriate. From the time of T-cell infusion to date of death, assessed up to 12 months
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