Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT05950802

Optimizing lymphoDepletion to Improve Outcomes In Patients Receiving Cell Therapy With Yescarta

Led by University Health Network, Toronto · Updated on 2025-12-08

40

Participants Needed

1

Research Sites

215 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a Phase 1b study of participants with Diffuse Large B Cell Lymphoma (DLBCL). The purpose of this study is to identify an optimized lymphodenpletion (LD) regimen by evaluating standard and intermediate doses of Fludarabine (Flu) / Cyclophosphamide (Cy) with or without a fixed dose of total lymphoid irradiation (TLI) in the setting of standard of care CAR T cell therapy.

CONDITIONS

Official Title

Optimizing lymphoDepletion to Improve Outcomes In Patients Receiving Cell Therapy With Yescarta

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older at the time of consent
  • Life expectancy of at least 12 weeks
  • Biopsy-confirmed relapsed or refractory large B cell lymphoma, including DLBCL, transformed follicular lymphoma, or primary mediastinal B cell lymphoma
  • Measurable disease by imaging with at least one lesion greater than 1.5 cm that is FDG avid
  • At least 2 weeks or 5 half-lives have passed since any prior systemic cancer therapy
  • Eligible for standard of care CAR T cell therapy after two or more systemic therapy lines, including anti-CD20 antibody and anthracycline chemotherapy
  • No active central nervous system disease
  • Stable enough to undergo CAR T-cell therapy with good performance status (ECOG 0 or 1)
  • No prior adoptive T-cell immunotherapy
  • Not HIV positive
  • No prior allogeneic stem cell transplant
  • Adequate bone marrow, kidney, liver, lung, and heart function
  • Negative pregnancy test for females of childbearing potential
  • Male participants agree to use condoms during and for 6 months after treatment
  • Must have an apheresis product accepted for manufacturing
Not Eligible

You will not qualify if you...

  • Tumor bulk of 10 cm or more after bridging therapy
  • History of other cancers unless disease-free for at least 3 years (except certain skin and in situ cancers)
  • History of Richter's transformation of chronic lymphocytic leukemia
  • Prior allogeneic stem cell transplant
  • Received fewer than two therapy lines for large B cell lymphoma
  • Prior CD19 targeted therapy
  • Use of high-dose corticosteroids or certain other therapies within specified timeframes before leukapheresis
  • Prior chimeric antigen receptor or genetically modified T-cell therapy
  • Uncontrolled infections requiring IV antibiotics
  • Known HIV, active hepatitis B or C infection unless undetectable viral load after treatment
  • Active tuberculosis
  • Presence of indwelling lines or drains except certain central venous catheters
  • Detectable cancer cells in cerebrospinal fluid or active CNS involvement
  • Significant non-cancerous CNS disorders or autoimmune disease affecting CNS
  • Cardiac lymphoma involvement or recent serious heart conditions
  • Need for urgent therapy due to tumor effects like obstruction
  • Autoimmune disease requiring systemic immunosuppression in last 2 years
  • History of certain lung diseases or active pneumonitis on chest scan
  • Recent symptomatic blood clots
  • Any condition interfering with safety or efficacy assessment
  • Severe allergic reactions to tocilizumab or study agents
  • Recent live vaccine use
  • Pregnant or breastfeeding women
  • Unwillingness to practice birth control during and 6 months after treatment
  • Unlikely to complete study visits or comply with requirements

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

4

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