OncoMatch/Clinical Trials/NCT05963217

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

Is NCT05963217 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including TBI-2001 and Cyclophosphamide for relapsed or refractory cd19+ b-cell lymphoma.

Phase 1RecruitingUniversity Health Network, TorontoNCT05963217Data as of May 2026

Treatment: TBI-2001 · Cyclophosphamide · Fludarabine — 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).

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Extracted eligibility criteria

Cancer type

Chronic Lymphocytic Leukemia

Non-Hodgkin Lymphoma

Biomarker criteria

Required: CD19 positive

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 2 prior lines

Cannot have received: CD19-directed therapy

Any prior CD19 directed therapy

Cannot have received: allogeneic-HSCT

Received allogeneic-HSCT

Lab requirements

Blood counts

adequate key organ function (bone marrow, heart, lung, liver, renal, etc)

Kidney function

adequate key organ function (bone marrow, heart, lung, liver, renal, etc)

Liver function

adequate key organ function (bone marrow, heart, lung, liver, renal, etc)

Cardiac function

adequate key organ function (bone marrow, heart, lung, liver, renal, etc)

Patients must have adequate key organ function (bone marrow, heart, lung, liver, renal, etc)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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