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 (Jun 2026). This Early Phase 1 trial studies GT801 for b-cell acute lymphoblastic leukemia (b-all).
Treatment: GT801 — The 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
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)
Demographics
Prior therapy
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.
Frequently asked questions
Is NCT07205315 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior gene-modified or gene-edited cellular therapy products, hematopoietic stem cell transplantation disqualifies patients from enrollment.
Does this trial require CD19?
Yes, CD19 positivity is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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