CAR-T Therapy for B-Cell Lymphoma
Trial Summary
What is the purpose of this trial?
This trial tests TBI-2001, a therapy that modifies a patient's immune cells to better attack cancer. It targets patients whose cancers have not responded to other treatments. The treatment works by enhancing the immune cells' ability to kill cancer cells.
Will I have to stop taking my current medications?
The trial protocol suggests that you may need to stop certain medications before apheresis and lymphodepleting chemotherapy, following specific guidelines. However, if you are on targeted or biological therapies that don't affect the collection of lymphocytes, you might not need a washout period, but this requires approval from the Sponsor.
What data supports the effectiveness of the treatment CAR-T Therapy for B-Cell Lymphoma?
Is CAR-T therapy for B-cell lymphoma safe?
How is the treatment TBI-2001 unique for B-cell lymphoma?
TBI-2001 is a type of CAR T-cell therapy, which uses a patient's own T-cells (a type of immune cell) that are modified to better recognize and attack B-cell lymphoma cells by targeting the CD19 protein on their surface. This approach is different from traditional treatments because it involves engineering the patient's immune cells to fight the cancer, offering a new option for those with relapsed or refractory B-cell lymphoma.1371011
Research Team
Marcus Butler
Principal Investigator
Princess Margaret Cancer Centre
Eligibility Criteria
This trial is for adults over 18 with CD19+ B-cell Lymphoma, CLL, or SLL who've had at least two prior treatments. They should be in good health with a life expectancy of more than 4 months and have not received cancer treatment within the last two weeks. Pregnant women, those with certain medical conditions or history of organ transplant requiring immunosuppression are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Pre-treatment
Participants receive conditioning chemotherapy with cyclophosphamide and fludarabine
Treatment
Participants receive TBI-2001 CAR-T cells intravenously following dose-escalation cohorts
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Long-term follow-up is conducted for 5 years following the infusion of TBI-2001
Treatment Details
Interventions
- Cyclophosphamide
- Fludarabine
- TBI-2001
Find a Clinic Near You
Who Is Running the Clinical Trial?
University Health Network, Toronto
Lead Sponsor
Takara Bio Inc.
Industry Sponsor