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Trial 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
NCT ID:
NCT05963217
Condition:
Relapsed or Refractory CD19+ B-cell Lymphoma
Relapsed or Refractory Chronic Lymphocytic Leukemia
Relapsed or Refractory Small Lymphocytic Lymphoma
Conditions: Official terms:
Lymphoma
Leukemia
Lymphoma, B-Cell
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Cyclophosphamide
Fludarabine
Conditions: 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
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
TBI-2001
Description:
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.
Arm group label:
Experimental: Dose Level 1 to 3
Intervention type:
Drug
Intervention name:
Cyclophosphamide
Description:
IV Cyclophosphamide (for 3 days) will be administered as conditioning before cell
infusion with TBI-2001.
Arm group label:
Experimental: Dose Level 1 to 3
Intervention type:
Drug
Intervention name:
Fludarabine
Description:
IV Fludarabine (for 3 days) will be administered as conditioning before cell infusion
with TBI-2001.
Arm group label:
Experimental: Dose Level 1 to 3
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).
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
Criteria for eligibility:
Criteria:
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:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Princess Margaret Cancer Centre
Address:
City:
Toronto
Zip:
M5G 2M9
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Marcus Butler, M.D.
Phone:
416-946-4501
Phone ext:
5485
Email:
marcus.butler@uhn.ca
Investigator:
Last name:
Marcus Butler, M.D.
Email:
Principal Investigator
Start date:
July 26, 2023
Completion date:
May 30, 2026
Lead sponsor:
Agency:
University Health Network, Toronto
Agency class:
Other
Collaborator:
Agency:
Takara Bio Inc.
Agency class:
Industry
Source:
University Health Network, Toronto
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05963217
