OncoMatch/Clinical Trials/NCT07862010
Study of GI001 in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma and B-Cell Acute Lymphoblastic Leukemia
Official title: An Exploratory Clinical Study Evaluating GI001 in the Treatment of Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma and B-Cell Acute Lymphoblastic Leukemia
Is NCT07862010 recruiting? Yes, currently enrolling (Oct 2026). This Early Phase 1 trial studies GI001 for b-cell non-hodgkin lymphoma.
Treatment: GI001 — This is an open-label, multi-cohort, investigator-initiated clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of GI001 in adult patients with relapsed or refractory B-cell Non-Hodgkin Lymphoma (R/R B-NHL) and B-cell Acute Lymphoblastic Leukemia (R/R B-ALL). GI001 is an exploratory, in vivo chimeric antigen receptor T-cell (CAR-T) therapy targeting the CD19 antigen. Unlike traditional CAR-T cell therapies that require extensive in vitro cell manufacturing, GI001 is administered directly to the patient via intravenous infusion, aiming to generate CAR-T cells directly within the patient's body. The study consists of two main phases: * Dose-Escalation Phase: This phase will evaluate four ascending dose levels to assess safety, identify any Dose-Limiting Toxicities (DLTs), determine the Maximum Tolerated Dose (MTD), and establish the Recommended Dose for Expansion (RDE). It utilizes an accelerated titration design for the initial doses, followed by a standard "3+3" dose-escalation design. * Dose-Expansion Phase ： Once the RDE is identified, additional patients will be enrolled to further evaluate the safety, clinical efficacy, pharmacokinetics, and pharmacodynamics of GI001 at the selected dose(s). The primary focus of the study is to continuously monitor adverse events and evaluate the overall safety profile. Secondary objectives include assessing clinical response rates (such as Objective Response Rate and Complete Response Rate), survival outcomes, and the expansion levels of CAR-T cells in the peripheral blood.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Non-Hodgkin Lymphoma
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: CD19 expression (positive)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Must have received: standard therapy — first-line and second-line or later for B-NHL; at least 2 cycles of standard chemotherapy for B-ALL
participants must have received adequate prior therapy; participants with CD20-positive disease must have failed or relapsed after anti-CD20 monoclonal antibody therapy. For B-ALL: failure to achieve CR after at least 2 cycles of standard chemotherapy, or late relapse (>=12 months) after CR with failure to achieve CR after at least 1 additional cycle; or relapse after hematopoietic stem cell transplantation, or failure to achieve remission with the last therapy in participants receiving salvage therapy after HSCT; or failure to achieve CR or relapse after at least 2 tyrosine kinase inhibitors (TKIs) (participants with TKI-resistance mutations such as T315I/A, V299L, F317L/V/I/C, G250E, Y253H, E255K/V, or F359V/C are not required to have received at least 2 TKIs), or intolerance to or contraindication for TKIs, in Philadelphia chromosome-positive (Ph+) B-ALL.
Cannot have received: gene therapy product (including CAR-T therapy)
Exception: except participants with no in vivo CAR-T, normal T cell count and function, and CD19-positive tumor
Prior treatment with any gene therapy product, including CAR-T therapy (except participants with no in vivo CAR-T, normal T cell count and function, and CD19-positive tumor).
Cannot have received: anti-CD19/anti-CD3 therapy or any other anti-CD19 therapy
Exception: except participants with normal T cell count and function and CD19-positive tumor
Prior treatment with any anti-CD19/anti-CD3 therapy or any other anti-CD19 therapy (except participants with normal T cell count and function and CD19-positive tumor).
Lab requirements
Blood counts
ANC > 0.5 x 10^9/L (no short-acting G-CSF within 7 days and no long-acting G-CSF within 14 days before testing); ALC ≥ 0.5 x 10^9/L; platelet count ≥ 30 x 10^9/L (no platelet transfusion within 7 days before testing); hemoglobin ≥ 80 g/L (no red blood cell transfusion within 7 days before testing; recombinant erythropoietin permitted); absolute CD3+ T cell count ≥ 150/uL
Kidney function
creatinine clearance (CrCl) ≥ 60 mL/min (Cockcroft-Gault formula)
Liver function
ALT and AST ≤ 3 x ULN; total serum bilirubin ≤ 2 x ULN
Cardiac function
LVEF ≥ 55%; oxygen saturation > 91%
Adequate organ function meeting all of the following laboratory results before enrollment: Hematology: bone marrow reserve for R/R B-NHL participants must meet: absolute neutrophil count (ANC) > 0.5 x 10^9/L (no short-acting G-CSF within 7 days and no long-acting G-CSF within 14 days before testing); absolute lymphocyte count (ALC) ≥ 0.5 x 10^9/L; platelet count ≥ 30 x 10^9/L (no platelet transfusion within 7 days before testing); hemoglobin ≥ 80 g/L (no red blood cell transfusion within 7 days before testing; recombinant erythropoietin permitted). All participants (B-NHL and B-ALL) require absolute CD3+ T cell count ≥ 150/uL. Hepatic: ALT and AST ≤ 3 x ULN; total serum bilirubin ≤ 2 x ULN. Renal: creatinine clearance (CrCl) ≥ 60 mL/min (Cockcroft-Gault formula). Coagulation: fibrinogen ≥ 1.0 g/L; activated partial thromboplastin time ≤ 1.5 x ULN; prothrombin time (PT) ≤ 1.5 x ULN. Cardiac: left ventricular ejection fraction (LVEF) ≥ 55%; oxygen saturation > 91%.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07862010 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior gene therapy product (including CAR-T therapy), anti-CD19/anti-CD3 therapy or any other anti-CD19 therapy disqualifies patients from enrollment.
Does this trial require CD19?
Yes, CD19 expression 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.
Check if I qualify