CART19 in Adult Patients With Minimal Residual Disease During Upfront Treatment for ALL

NCT02935543 | Terminated Phase 2 Results DMC

• 1 other identifier: UPCC39416, 825668
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single center, single arm, open-label phase 2 study to determine the efficacy of autologous T cells expressing CD19 chimeric antigen receptors expressing tandem TCRζ and 4-1BB (TCRζ/4-1BB) co-stimulatory domains (referred to as "CART19" cells) in adults with minimal residual disease (MRD) during upfront treatment for CD19+ acute lymphoblastic leukemia.

Conditions

Leukemia, Acute Lymphoblastic

Outcome Measures

Primary Outcomes (1)

• The Incidence of Conversion of Minimal Residual Disease (MRD) to <0.01%

  The incidence of conversion of minimal residual disease (MRD) to \<0.01% after CART19 therapy in patients with MRD+ ALL during upfront treatment

  Day 28

Secondary Outcomes (6)

• Best Overall Survival (OS)

  one year

• Duration of Remission (DOR)

  one year

• Relapse Free Survival (RFS)

  one year

• Event Free Survival (EFS)

  one year

• Percentage of Manufacturing Products That do Not Meet Release Criteria for Vector Transduction Efficiency, T Cell Product Purity, Viability, Sterility or Due to Tumor Contamination.

  prior to day 1

Study Arms (1)

CART19

EXPERIMENTAL

CART19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCRz:41BB administered by IV infusion.

Biological: CART 19

Interventions

CART 19 BIOLOGICAL

CART19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCRz:41BB administered by IV infusion. Subjects will receive 1-5 x 10\^8 transduced CAR T cells as a split dose over three days as follows:Day 1, 10% fraction: 1-5x10\^7 CART19 cells, Day 2, 30% fraction: 3x10\^7-1.5x10\^8 CART19 cells, Day 3, 60% fraction: 6x10\^7-3x10\^8 CART19 cells

CART19

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with CD19+, B cell Acute Lymphoblastic Leukemia (B-ALL) who have 0.01%≤MRD\<10% during upfront treatment
• Patients must be within 18 months of initial ALL diagnosis
• Age ≥18 years
• Adequate organ function defined as:
• Creatinine ≤ grade 2
• ALT/AST ≤3x upper limit of normal range for age
• Direct bilirubin ≤2.0 mg/dl
• Adequate pulmonary function defined as ≤ grade 2 dyspnea and ≤ grade 2 hypoxia
• Cardiac Left Ventricle Ejection Fraction (LVEF) ≥ 40% confirmed by ECHO/MUGA
• Patients with CNS3 disease will be eligible if CNS disease is responsive to therapy.
• Expression of CD19 on leukemic blasts demonstrated by flow cytometry or immunohistochemistry of bone marrow or peripheral blood
• Adequate performance status defined as ECOG Performance Status 0 or 1
• Provides written informed consent
• Subjects of reproductive potential must agree to use acceptable birth control methods, as described in protocol

You may not qualify if:

• Active, uncontrolled infection
• Active hepatitis B or hepatitis C
• HIV Infection
• Class III/IV cardiovascular disability according to the New York Heart Association Classification (see Appendix 2)
• Subjects with clinically apparent arrhythmia or arrhythmias who are not stable on medical management within two weeks of enrollment.
• Pregnant or nursing (lactating) women
• Patients with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system, and unrelated to leukemia or previous leukemia treatment.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Regulatory Lead
• Organization: Univ. of Pennsylvania

psom-ind-ide@pobox.upenn.edu

215-662-4484

Study Officials

• Noelle Frey, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2016
• First Posted: October 17, 2016
• Study Start: October 1, 2016
• Primary Completion: December 12, 2018
• Study Completion: December 12, 2018
• Last Updated: June 22, 2023
• Results First Posted: February 5, 2020

Record last verified: 2020-01

Locations

US (1)