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RecruitingNCT05963217Updated Jun 9, 2026

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

A Phase 1 interventional study of TBI-2001 and Cyclophosphamide in Relapsed or Refractory CD19+ B-cell Lymphoma, Relapsed or Refractory Chronic Lymphocytic Leukemia and Relapsed or Refractory Small Lymphocytic Lymphoma, sponsored by University Health Network, Toronto. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-09.

Sponsored by University Health Network, Toronto · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2023; still recruiting 3 years 2 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
19
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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).

Read the detailed description

TBI-2001 is a next-generation CAR-T product including costimulatory sequences that lead to the activation of cytokine-related JAK/STAT signaling pathways. This is a first-in-human study of TBI-2001 and will follow a 3+3 design of dose-escalation cohorts. Additional subjects will be treated with TBI-2001 at the determined recommended phase 2 dose (RP2D) following cyclophosphamide and fludarabine pre-treatment. Long-term follow-up is conducted for 5 years following the infusion of TBI-2001

02

Conditions studied

  • Relapsed or Refractory CD19+ B-cell Lymphoma
  • Relapsed or Refractory Chronic Lymphocytic Leukemia
  • Relapsed or Refractory Small Lymphocytic Lymphoma

Keywords

  • CD19+ B-cell Lymphoma
  • Chronic Lymphocytic Leukemia
  • CLL
  • Small Lymphocytic Lymphoma
  • SLL
  • Lymphoma
  • TBI-2001
  • Anti-CD19 CAR Expressing T cell Therapy
  • CD19 CAR Gene-Transduced Lymphocyte
  • Adoptive Immunotherapy
  • Genetically Engineered Lymphocyte Therapy
  • Retroviral Vector
  • Neoplasms by Histologic Type
  • Neoplasms
  • Neoplasms, Experimental
  • Immune System Diseases
  • Chimeric Antigen Receptor
03

In context

Recurrence

4,279 studies on the registry are indexed under Recurrence; 988 are open to participants now.

This study's planned enrollment of 19 is below the median of 50 across 3,374 interventional studies indexed under Recurrence.

Browse Recurrence studies →

Lead sponsor

University Health Network, Toronto is the lead sponsor of 1,411 studies on the registry; 292 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients with histologically or cytologically confirmed CD19 positive B cell Non-Hodgkin Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL), or Small Lymphocytic Lymphoma (SLL) who have received at least 2 prior therapies.
  2. Phase Ib cohort will enroll CLL/SLL patients only.
  3. ECOG Performance Status 0 or 1.
  4. Age ≥18 years at time of consent.
  5. Life expectancy greater than 4 months.
  6. For cessation of therapies prior to apheresis and lymphodepleting chemotherapy (bridging therapies), the institutional (UHN) SOPs related to Kymriah will be followed. However, an exception will be made for targeted and biological therapies that decrease circulating disease and are not expected to negatively impact successful harvest of lymphocytes by apheresis. In these cases, after discussion with and approval by the Sponsor, no washout will be required.
  7. Patients must have adequate key organ function (bone marrow, heart, lung, liver, renal, etc)
  8. Consent must be appropriately obtained in accordance with applicable local and regulatory requirements.
  9. The treating investigator should consider the patient to have disease that is incurable, and that the patient would be a reasonable candidate for future treatment with TBI-2001 within the next 3 months

Exclusion criteria

Exclusion Criteria:

  1. Uncontrolled intercurrent illnesses or medical conditions that may interfere with trial participation.
  2. Active or prior documented autoimmune disease within the past 2 years.
  3. History of primary immunodeficiency.
  4. History of organ transplant that requires use of immunosuppressive medications.
  5. History hypersensitivity to components of manufacture or excipients of investigational drug.
  6. Untreated central nervous system (CNS) metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation, and/or corticosteroids.
  7. Other invasive malignancy within 2 years except for noninvasive malignancies
  8. Current or prior use of immunosuppressive medication within 14 days before apheresis.
  9. Any condition that, in the opinion of the investigator, would interfere with the evaluation of TBI-2001 or interpretation of subject safety or study results.
  10. Known history of untreated active tuberculosis.
  11. HIV positivity.
  12. Active HTLV or syphilis infection.
  13. Active hepatitis B or active hepatitis C. Subjects with a negative PCR assay for viral load for hepatitis B or C are permitted.
  14. Pregnant or lactating women.
  15. Received allogeneic-HSCT.
  16. Any prior CD19 directed therapy.
  17. Live vaccine within 28 days prior to apheresis.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
19 participants (estimated)

Study arms

  • Experimental
    Experimental: Dose Level 1 to 3

    0.3 to 3 x 10\^6 autologous CD19-CAR-T cells/kg per patient will be administered intravenously after a conditioning chemotherapy with cyclophosphamide and fludarabine.

    Biological: TBI-2001 · Drug: Cyclophosphamide · Drug: Fludarabine

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.

06

What researchers measure

Primary outcomes

  1. Safety of TBI-2001

    Dose Limiting Toxicities (DLTs)

    Time frame: One month

  2. Safety of TBI-2001

    Adverse event (AEs)

    Time frame: One year

  3. Safety of TBI-2001

    Laboratory testing- RCR appearance and Clonality

    Time frame: One year

  4. Recommended phase 2 dose (RP2D) of TBI-2001

    RP2D to be determined during the dose escalation cohort

    Time frame: One year

Secondary outcomes

  1. Efficacy of TBI-2001; Overall Response Rate (ORR)

    Overall Response Rate (ORR) (Complete Response (CR)+Partial Response(PR))

    Time frame: One year

  2. Efficacy of TBI-2001; Durable Response Rate (DRR)

    Durable Response Rate (DRR) as defined as CR or PR sustained for at least 6 months

    Time frame: One year

  3. Efficacy of TBI-2001; Progression free survival (PFS)

    Progression free survival

    Time frame: One year

  4. Efficacy of TBI-2001; Overall survival (OS)

    Overall survival

    Time frame: One year

Other outcomes

  1. Persistence of TBI-2001

    Percentage of CAR T in peripheral blood and bone marrow using PCR and Flow cytometry.

    Time frame: One year

  2. Minimal residual disease (MRD) negative rate (in CLL patients)

    MRD negative rate

    Time frame: One year

07

Study locations

1 of 1 sites recruiting
  • Princess Margaret Cancer Centre
    Toronto, Ontario M5G 2M9, Canada
    • Marcus Butler, M.D. · Contact · marcus.butler@uhn.ca · 416-946-4501
    • Marcus Butler, M.D. · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05963217
Lead sponsor
University Health Network, Toronto
Collaborators
Takara Bio Inc.
Responsible party
Sponsor
First posted
Jul 27, 2023
Start date
Jul 26, 2023
Primary completion
Jun 30, 2028 (estimated)
Completion
Jun 30, 2028 (estimated)
Last update
Jun 9, 2026

Study contacts

Marcus Butler, M.D.
Contact
tip@uhn.ca
416-946-4501 ext. 2911
Marcus Butler, M.D.
principal investigator · Princess Margaret Cancer Centre

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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