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OncoMatch/Clinical Trials/NCT07205315

A Clinical Study Evaluating the Safety and Efficacy of GT801 Injection in Adult Patients With Relapsed/Refractory CD19-positive B-cell Hematologic Malignancies and Autoimmune Hemolytic Anemia

Is NCT07205315 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies GT801 for b-cell acute lymphoblastic leukemia (b-all).

Early Phase 1RecruitingGrit BiotechnologyNCT07205315Data as of May 2026

Treatment: GT801The goal of this clinical study is to evaluate the safety and efficacy of GT801 injection in adult patients with relapsed/refractory CD19-positive B-cell hematologic malignancies and autoimmune hemolytic anemia.

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Extracted eligibility criteria

Cancer type

Acute Lymphoblastic Leukemia

Chronic Lymphocytic Leukemia

Non-Hodgkin Lymphoma

Biomarker criteria

Required: CD19 positivity

CD19 positivity confirmed by flow cytometry and/or histopathology (excluding autoimmune hemolytic anemia)

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 2 prior lines

Must have received: drug treatment

Disease progression or recurrence after at least second-line drug treatment

Cannot have received: gene-modified or gene-edited cellular therapy products

Exception: autologous immune cell therapy products without gene modification or editing, provided that the interval from the last administration to the first dose of GT801 is more than 1 year

Prior receipt of gene-modified or gene-edited cellular therapy products (except for autologous immune cell therapy products without gene modification or editing, provided that the interval from the last administration to the first dose of GT801 is more than 1 year)

Cannot have received: hematopoietic stem cell transplantation

Exception: if with therapeutic intent within 12 weeks of planned GT801 infusion; or if allogeneic and ≤ 6 months since transplant

Participants who undergo hematopoietic stem cell transplantation with therapeutic intent within 12 weeks of planned GT801 infusion; if the participant has a history of hematopoietic stem cell transplantation, the time since the participant received allogeneic hematopoietic stem cell transplantation is ≤ 6 months

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

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