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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
BIOLOGICALGT801 Injection
GT801 Injection
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07205315
Related Trials
AZD0486 as Monotherapy in B-cell Acute Lymphoblastic Leukaemia
NCT0613711880 locations
Collection of Human Samples to Study Hairy Cell and Other Leukemias, and to Develop Recombinant Immunotoxins for Cancer Treatment
NCT010873331 location
Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
NCT057241211 location
A Study of NX-5948 in Adults With Relapsed/Refractory B-cell Malignancies
NCT0513102262 locations
A Study of NX-5948 in Adults With CLL/SLL Previously Treated With a Bruton's Tyrosine Kinase Inhibitor and a B-cell Lymphoma-2 Inhibitor (DAYBreak CLL-201)
NCT0722150020 locations