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New treatment option for Relapsed or Refractory CD19+ B-cell Lymphoma
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
ClinicalTrials.gov ID: NCT05963217
What this study is testing
What is TBI-2001?
TBI-2001 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for relapsed or refractory cd19+ b-cell lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients with histologically or cytologically confirmed CD19 positive B cell Non-Hodgkin Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL), or Small...
- 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.
You likely can't join if
- 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...
See the full eligibility criteria
- 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...
- 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...
- 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
- 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. people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.