RecruitingEarly Phase 1NCT07205315

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


Sponsor

Grit Biotechnology

Enrollment

28 participants

Start Date

Sep 26, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a CAR-T cell therapy called GT801 — which uses a patient's own immune cells modified to attack cancer — in adults with blood cancers that have relapsed or stopped responding to treatment. The cancers targeted include certain types of leukemia, lymphoma, and a rare immune condition called autoimmune hemolytic anemia. **You may be eligible if...** - You are 18–75 years old with relapsed or refractory B-cell acute lymphoblastic leukemia, chronic lymphocytic leukemia, B-cell non-Hodgkin lymphoma, or autoimmune hemolytic anemia - Your cancer has not responded to or came back after at least two prior treatments - Your cancer cells test positive for the CD19 protein (for blood cancers) - Your overall health allows for treatment (ECOG 0–1 for blood cancers) - Your expected survival is more than 12 weeks - Enough time has passed since your last cancer treatment **You may NOT be eligible if...** - Your cancer is a different type than those listed - You have had a prior stem cell transplant or CAR-T therapy involving certain targets - You have active brain involvement by the cancer - You have uncontrolled serious infections, heart problems, or organ dysfunction - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALGT801 Injection

GT801 Injection


Locations(2)

Zhengzhou Yihe Hospital

Zhengzhou, Henan, China

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

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NCT07205315


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