Who may be eligible for this relapsed or refractory CD19-positive B-cell blood cancer clinical trial?

Adults aged 18 to 75 years with relapsed or refractory CD19-positive B-cell blood cancers or autoimmune hemolytic anemia may be eligible. Participants should have had disease progression after at least two prior treatments and meet specific health criteria. Both males and females can participate. Please review eligibility criteria for more details.

Is there any cost to participate in this relapsed or refractory CD19-positive B-cell blood cancer clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses and other costs related to participation may vary and are not guaranteed to be covered.

Actively Recruiting

Early Phase 1

Age: 18Years - 75Years

All Genders

ID07205315

Safety and Effectiveness Study of GT801 Injection in Adults With Relapsed or Refractory CD19-positive B-cell Blood Cancers and Autoimmune Hemolytic Anemia

Q: What is GT801 studying for relapsed or refractory CD19-positive B-cell blood cancers and autoimmune hemolytic anemia?

GT801 is being studied to evaluate its safety and effectiveness in adults with relapsed or refractory CD19-positive B-cell blood cancers and autoimmune hemolytic anemia. This research aims to understand how patients respond to this treatment and any side effects that may occur. The study is sponsored by Grit Biotechnology.

Led by Grit Biotechnology · Updated on 2026-07-20

Participants Needed

Research Sites

39 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying the safety and effectiveness of GT801 injection in adults who have relapsed or refractory CD19-positive B-cell blood cancers, including acute lymphoblastic leukemia, chronic lymphocytic leukemia, non-Hodgkins lymphoma, and autoimmune hemolytic anemia. This early phase 1 study aims to understand how well the treatment works and its side effects in this group of patients. Participants will receive the GT801 injection as the study treatment. The study focuses on one group receiving this intervention. The treatment schedule and dosing details are not specified, but safety and response to the treatment will be monitored over a period of time, including up to 12 months after infusion. During the study, participants will be closely monitored for side effects and treatment responses through various assessments. Researchers will measure the proportion of participants experiencing dose-limiting toxicity within 28 days and track adverse events up to 3 months after infusion. They will also evaluate overall response rates, duration of response, progression-free survival, and other outcome measures related to both the blood cancers and autoimmune hemolytic anemia for up to 12 months. The study includes regular follow-up visits and evaluations to gather this information.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 75Years

All Genders

Eligibility Criteria

You may qualify if you...

Aged 18 to 75 years (inclusive), male or female
Diagnosis of relapsed or refractory acute B-cell lymphoblastic leukemia, chronic lymphocytic leukemia, B-cell Non-Hodgkin's Lymphoma, or autoimmune hemolytic anemia
Disease progression or recurrence after at least two prior drug treatments
CD19 positivity confirmed by flow cytometry or histopathology (excluding autoimmune hemolytic anemia)
Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1 (excluding autoimmune hemolytic anemia)
Expected survival period longer than 12 weeks
For prior systemic therapy, at least 2 weeks or 5 half-lives must have passed before starting study treatment
For prior immune checkpoint inhibitor treatment, at least 3 half-lives or 28 days must have passed before starting study treatment
For autoimmune hemolytic anemia, specific prior treatments and durations of therapies such as glucocorticoids, rituximab, immunosuppressants, or chemotherapy agents must be met

You will not qualify if you...

History or current central nervous system leukemia/lymphoma or brain metastases
Presence of myelofibrosis, myelodysplastic syndromes, aplastic anemia, or other malignant hematological diseases
Coagulation disorders or high bleeding risk conditions
Recent severe or life-threatening bleeding
Secondary autoimmune hemolytic anemia caused by drugs or infections
Hereditary or other acquired hemolytic diseases
Hematopoietic stem cell transplantation within 12 weeks before planned GT801 infusion
Allogeneic hematopoietic stem cell transplantation within 6 months
Hormonal drug administration within 14 days before infusion (except for specified cases)
Active hepatitis B or C infection (with exceptions for controlled cases)
Central nervous system diseases or history thereof
Significant cardiovascular, pulmonary, or metabolic conditions within 6 months before consent
Prior gene-modified or gene-edited cellular therapy products
Autoimmune diseases causing organ damage or requiring systemic immunosuppression within past 2 years

Research Team

Dehui Zou

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