Study of GI001 in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma and B-Cell Acute Lymphoblastic Leukemia
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek od 18 do 75 lat
- •Rozpoznanie chłoniaka nieziarniczego B-komórkowego lub białaczki limfoblastycznej B-komórkowej, które wróciły lub nie reagują na leczenie
- •Wcześniejsze leczenie standardowe lub oporne na leczenie CD20
- •Pozytywne wyniki testu CD19 w komórkach nowotworowych
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Last updated (source)
- October 7, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
The 920th Hospital of Joint Logistics Support Force, PLA
Yunnan, China
Trial contact
Sanbing Wang Principal Investigator
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 10/8/2026.
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