NCT04419909

Brief Summary

This research study is designed to evaluate the effects of retreatment with CTL019/CTL119 in patients with late relapse of B-cell lymphomas.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
24mo left

Started May 2026

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress6%
May 2026Jul 2028

First Submitted

Initial submission to the registry

May 28, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
5.9 years until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

July 2, 2025

Status Verified

June 1, 2025

Enrollment Period

2.2 years

First QC Date

May 28, 2020

Last Update Submit

June 27, 2025

Conditions

Lymphoma, B-Cell

Keywords

CTL019CTL119CAR T-cellCART

Outcome Measures

Primary Outcomes (1)

  • Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Safety of retreatment with CTL019/CTL119 as measured by treatment-related events

    At time of consent through 1 year after the subject received CTL019/CTL119

Secondary Outcomes (1)

  • Overall response rate using Cheson 2007 criteria

    Month 3 post-infusion

Study Arms (1)

Retreatment with CTL019/CTL119

EXPERIMENTAL

All subjects will receive retreatment with CTL019/CTL119 and be followed per the schedule of procedures.

Drug: CD19 redirected autologous T cells (CTL019 or CTL119 cells)

Interventions

CD19 redirected autologous T cells (CTL019 or CTL119 cells)DRUG

Retreatment with CD19-directed Chimeric Antigen Receptor-modified T Cells (CART19 cells) or huCD19-directed Chimeric Antigen Receptor-modified T Cells (huCART19 cells) in subjects with late relapse of B-cell lymphomas.

Retreatment with CTL019/CTL119

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diffuse Large B-Cell Lymphoma or Follicular lymphoma, previously identified as CD19+
  • Previously treated on UPCC13413/ NCT02030834 with CTL019/CTL119, with historical manufactured product available at Penn for reinfusion
  • Previous complete response to CAR T-cells with a duration ≥ 6 months (defined as 168 days)
  • No available curative treatment options (such as autologous or allogeneic HSCT) with limited prognosis (several months to \< 2 year survival) with currently available therapies.
  • Age ≥18 years
  • Creatinine \< 1.6 mg/dL
  • ALT/AST \< 3x upper limit of normal
  • Bilirubin \< 2.0 mg/dL, unless subject has Gilbert's Syndrome (≤3.0 mg/dL)
  • Measurable or assessable disease according to the "Revised Response Criteria for Malignant Lymphoma" (Cheson et al., J. Clin. Onc., 2007)88. Patients in complete remission with no evidence of disease are not eligible.
  • Performance status (ECOG) 0 or 1.
  • Left Ventricle Ejection Fraction (LVEF) \> 40% confirmed by ECHO/MUGA
  • Agree to contraceptive requirements outlined in Section 4.3.
  • Provide written informed consent.

You may not qualify if:

  • Uncontrolled active infection.
  • Active hepatitis B or hepatitis C infection.
  • Any uncontrolled active medical disorder that would preclude participation as outlined.
  • Class III/IV cardiovascular disability according to the New York Heart Association Classification (see Appendix 1).
  • HIV infection.
  • Patients with active CNS involvement by malignancy. Patients with prior CNS disease that has been effectively treated will be eligible providing treatment was \>4 weeks before enrollment
  • Patients with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Lymphoma, B-Cell

Interventions

tisagenlecleucel

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Stephen J Schuster

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephen J Schuster, MD

CONTACT

215.614.1846schustes@pennmedicine.upenn.edu

Emerging Medicine

CONTACT

855-216-0098PennCancerTrials@careboxhealth.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2020

First Posted

June 9, 2020

Study Start

May 1, 2026

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2028

Last Updated

July 2, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)