Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT05963217

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

Led by University Health Network, Toronto · Updated on 2025-07-02

19

Participants Needed

1

Research Sites

148 weeks

Total Duration

On this page

Sponsors

U

University Health Network, Toronto

Lead Sponsor

T

Takara Bio Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with confirmed CD19 positive B-cell Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, or Small Lymphocytic Lymphoma who have had at least 2 prior treatments
  • Phase Ib cohort includes only CLL/SLL patients
  • ECOG Performance Status 0 or 1
  • Age 18 years or older at time of consent
  • Life expectancy greater than 4 months
  • Follow institutional guidelines for stopping therapies before apheresis and chemotherapy, with possible exceptions for targeted biological therapies
  • Adequate key organ function including bone marrow, heart, lung, liver, and kidneys
  • Consent obtained according to local and regulatory requirements
  • Investigator considers the disease incurable and patient suitable for TBI-2001 treatment within 3 months
Not Eligible

You will not qualify if you...

  • Uncontrolled illnesses or medical conditions that could interfere with participation
  • Active or past autoimmune disease within the last 2 years
  • History of primary immunodeficiency
  • History of organ transplant needing immunosuppressive medication
  • Allergy to components of the investigational drug
  • Untreated central nervous system metastases requiring current treatment
  • Other invasive cancers within the past 2 years, except noninvasive types
  • Use of immunosuppressive drugs within 14 days before apheresis
  • Any condition interfering with evaluation or safety of TBI-2001
  • Untreated active tuberculosis
  • HIV positive status
  • Active HTLV or syphilis infection
  • Active hepatitis B or C (patients with negative viral load PCR allowed)
  • Pregnant or breastfeeding women
  • Prior allogeneic hematopoietic stem cell transplant
  • Previous CD19 directed therapy
  • Live vaccine received within 28 days before apheresis

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, M5G 2M9

Actively Recruiting

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Research Team

M

Marcus Butler, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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