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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

NCT05963217 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2025-07-02

No results posted yet for this study

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).

Conditions

  • Relapsed or Refractory CD19+ B-cell Lymphoma
  • Relapsed or Refractory Chronic Lymphocytic Leukemia
  • Relapsed or Refractory Small Lymphocytic Lymphoma

Interventions

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.

Sponsors & Collaborators

  • Takara Bio Inc.

    collaborator INDUSTRY

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Marcus Butler, M.D. · Princess Margaret Cancer Centre

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-26
Primary Completion
2026-03-30
Completion
2026-05-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05963217 on ClinicalTrials.gov