Status:
RECRUITING
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
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Takara Bio Inc.
Conditions:
Relapsed or Refractory CD19+ B-cell Lymphoma
Relapsed or Refractory Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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...
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 an...
Eligibility Criteria
Inclusion
- 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.
- Phase Ib cohort will enroll CLL/SLL patients only.
- ECOG Performance Status 0 or 1.
- Age ≥18 years at time of consent.
- Life expectancy greater than 4 months.
- 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.
- Patients must have adequate key organ function (bone marrow, heart, lung, liver, renal, etc)
- Consent must be appropriately obtained in accordance with applicable local and regulatory requirements.
- 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
- Uncontrolled intercurrent illnesses or medical conditions that may interfere with trial participation.
- Active or prior documented autoimmune disease within the past 2 years.
- History of primary immunodeficiency.
- History of organ transplant that requires use of immunosuppressive medications.
- History hypersensitivity to components of manufacture or excipients of investigational drug.
- Untreated central nervous system (CNS) metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation, and/or corticosteroids.
- Other invasive malignancy within 2 years except for noninvasive malignancies
- Current or prior use of immunosuppressive medication within 14 days before apheresis.
- 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.
- Known history of untreated active tuberculosis.
- HIV positivity.
- Active HTLV or syphilis infection.
- Active hepatitis B or active hepatitis C. Subjects with a negative PCR assay for viral load for hepatitis B or C are permitted.
- Pregnant or lactating women.
- Received allogeneic-HSCT.
- Any prior CD19 directed therapy.
- Live vaccine within 28 days prior to apheresis.
Key Trial Info
Start Date :
July 26 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2026
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT05963217
Start Date
July 26 2023
End Date
May 30 2026
Last Update
July 2 2025
Active Locations (1)
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1
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9