Trials / Recruiting
RecruitingNCT05963217
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
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)
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 19 (estimated)
- Sponsor
- University Health Network, Toronto · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Conditions
- Relapsed or Refractory CD19+ B-cell Lymphoma
- Relapsed or Refractory Chronic Lymphocytic Leukemia
- Relapsed or Refractory Small Lymphocytic Lymphoma
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | TBI-2001 | 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. |
| DRUG | Cyclophosphamide | IV Cyclophosphamide (for 3 days) will be administered as conditioning before cell infusion with TBI-2001. |
| DRUG | Fludarabine | IV Fludarabine (for 3 days) will be administered as conditioning before cell infusion with TBI-2001. |
Timeline
- Start date
- 2023-07-26
- Primary completion
- 2026-03-30
- Completion
- 2026-05-30
- First posted
- 2023-07-27
- Last updated
- 2025-07-02
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT05963217. Inclusion in this directory is not an endorsement.