Relapsed or Refractory CD19+ B-cell LymphomaPhase 1NCT05963217
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 study testing TBI-2001, Cyclophosphamide and Fludarabine in people with Relapsed or Refractory CD19+ B-cell Lymphoma and Relapsed or Refractory Chronic Lymphocytic Leukemia, run by University Health Network, Toronto at 1 site in Canada.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed or Refractory CD19+ B-cell Lymphoma, Relapsed or Refractory Chronic Lymphocytic Leukemia, Relapsed or Refractory Small Lymphocytic Lymphoma
- What is being tested?
- TBI-2001, Cyclophosphamide and Fludarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteCanada
- Study dates
- 26 Jul 2023to 30 Jun 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Marcus Butler, M.D., 416-946-4501 ext. 5485, marcus.butler@uhn.ca
Marcus Butler, M.D.
About this study
Official title: Phase I/Ib Study of TBI-2001 for Patients With Relapsed or Refractory CD19+ B-cell Lymphoma, Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL)
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
- Conditions
- Relapsed or Refractory CD19+ B-cell Lymphoma, Relapsed or Refractory Chronic Lymphocytic Leukemia, Relapsed or Refractory Small Lymphocytic Lymphoma
- Being tested
- TBI-2001, Cyclophosphamide, Fludarabine
- 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
- Medical subject headings
- Recurrence, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Neoplasms by Histologic Type, Neoplasms, Neoplasms, Experimental, Immune System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TBI-2001Biological
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.
CyclophosphamideDrug
IV Cyclophosphamide (for 3 days) will be administered as conditioning before cell infusion with TBI-2001.
FludarabineDrug
IV Fludarabine (for 3 days) will be administered as conditioning before cell infusion with TBI-2001.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Dose Level 1 to 3 | Experimental | 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. Receives: Biological: TBI-2001; Drug: Cyclophosphamide; Drug: Fludarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of TBI-2001
Dose Limiting Toxicities (DLTs)
Measured: One month
Safety of TBI-2001
Adverse event (AEs)
Measured: One year
Safety of TBI-2001
Laboratory testing- RCR appearance and Clonality
Measured: One year
Recommended phase 2 dose (RP2D) of TBI-2001
RP2D to be determined during the dose escalation cohort
Measured: One year
Secondary outcomes (4)
Efficacy of TBI-2001; Overall Response Rate (ORR)
Overall Response Rate (ORR) (Complete Response (CR)+Partial Response(PR))
Measured: One year
Efficacy of TBI-2001; Durable Response Rate (DRR)
Durable Response Rate (DRR) as defined as CR or PR sustained for at least 6 months
Measured: One year
Efficacy of TBI-2001; Progression free survival (PFS)
Progression free survival
Measured: One year
Efficacy of TBI-2001; Overall survival (OS)
Overall survival
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start26 Jul 2023
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory CD19+ B-cell LymphomaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Takara Bio Inc.
- Responsible party
- Sponsor
- Investigators
- Marcus Butler, M.D., Principal investigator, Princess Margaret Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05963217
- Sponsor's protocol ID
- TBI-200101
- Status last verified
- Jun 2026
- First submitted
- 27 Jun 2023
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/Ib Study of TBI-2001 for Patients With Relapsed or Refractory CD19+ B-cell Lymphoma, Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL)
- ClinicalTrials.gov ID
- NCT05963217
- Acronym / sponsor ID
- TBI-200101
- Conditions
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 19 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Takara Bio Inc.
- Study start
- 26 Jul 2023 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Dose Level 1 to 3 | Experimental | Biological: TBI-2001, Drug: Cyclophosphamide, Drug: Fludarabine0.3 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TBI-2001Phase-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. | Biological | Experimental: Dose Level 1 to 3 |
| CyclophosphamideIV Cyclophosphamide (for 3 days) will be administered as conditioning before cell infusion with TBI-2001. | Drug | Experimental: Dose Level 1 to 3 |
| FludarabineIV Fludarabine (for 3 days) will be administered as conditioning before cell infusion with TBI-2001. | Drug | Experimental: Dose Level 1 to 3 |
Primary outcome
Safety of TBI-2001
Time frame: One month
Dose Limiting Toxicities (DLTs)
Safety of TBI-2001
Time frame: One year
Adverse event (AEs)
Safety of TBI-2001
Time frame: One year
Laboratory testing- RCR appearance and Clonality
Recommended phase 2 dose (RP2D) of TBI-2001
Time frame: One year
RP2D to be determined during the dose escalation cohort
4 secondary outcomes
Efficacy of TBI-2001; Overall Response Rate (ORR)
Time frame: One year
Efficacy of TBI-2001; Durable Response Rate (DRR)
Time frame: One year
Efficacy of TBI-2001; Progression free survival (PFS)
Time frame: One year
Efficacy of TBI-2001; Overall survival (OS)
Time frame: One year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marcus Butler, M.D. principal investigator
Princess Margaret Cancer Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TBI-2001, Cyclophosphamide and Fludarabine in people with Relapsed or Refractory CD19+ B-cell Lymphoma and Relapsed or Refractory Chronic Lymphocytic Leukemia, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marcus Butler, M.D. (416-946-4501 ext. 2911, tip@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of TBI-2001 (time frame: One month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.