RecruitingPhase 1NCT05963217

Study of TBI-2001(Autologous CD19 Specific Chimeric Antigen Receptor (CAR) Gene-transduced T Lymphocytes) for Relapsed or Refractory CD19+ B-cell Lymphoma, CLL/SLL

Phase I/Ib Study of TBI-2001 for Patients With Relapsed or Refractory CD19+ B-cell Lymphoma, Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL)


Sponsor

University Health Network, Toronto

Enrollment

19 participants

Start Date

Jul 26, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase 1/1b, open-label, dose-escalation study to evaluate the safety and the efficacy of anti-CD19 chimeric antigen receptor (CAR) (TBI-2001) for relapsed or refractory CD19+ B-cell lymphoma Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing TBI-2001, a type of personalized immune cell therapy called CAR-T cell therapy, which takes a patient's own immune cells, genetically engineers them to attack cancer cells, and infuses them back. It targets CD19, a protein found on certain blood cancer cells. The study is for people with relapsed or treatment-resistant B-cell lymphomas, CLL, or SLL. **You may be eligible if...** - You are 18 or older with confirmed CD19-positive B-cell non-Hodgkin lymphoma, CLL, or SLL - You have received at least 2 prior treatments that did not work or stopped working - You are not eligible for or have exhausted other potentially curative treatment options - Your overall health is adequate for the procedure **You may NOT be eligible if...** - You have not received at least 2 prior therapies - You have active brain cancer involvement - You have uncontrolled infections or serious organ failure - You have had certain prior CAR-T therapies (depending on the study cohort) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALTBI-2001

Phase-I portion: cohort 1: 3×10\^5 cells/kg, cohort 2: 1×10\^6 cells/kg, cohort 3: 3×10\^6 cells/kg). Phase-Ib portion: The dose of Phase-Ib will be determined during the phase I portion.

DRUGCyclophosphamide

IV Cyclophosphamide (for 3 days) will be administered as conditioning before cell infusion with TBI-2001.

DRUGFludarabine

IV Fludarabine (for 3 days) will be administered as conditioning before cell infusion with TBI-2001.


Locations(1)

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

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NCT05963217