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Evaluation of GI001 for Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

NCT07584850 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2026-05-13

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the safety, tolerability, and preliminary efficacy in adult patients with relapsed or refractory (r/r) CD19-positive B-cell Non-Hodgkin Lymphoma (B-NHL) or B-cell Leukemia. The main questions it aims to answer are:

* What are the safety and tolerability profiles of GI001, specifically regarding the incidence of Dose-Limiting Toxicities (DLTs) and the determination of the Maximum Tolerated Dose (MTD)?
* What is the preliminary efficacy of GI001, measured by Objective Response Rate (ORR), Complete Response Rate (CRR), and Duration of Response (DOR)?
* What are the pharmacokinetic (expansion and persistence of CAR-T cells) and pharmacodynamic (cytokine changes) characteristics of GI001?

Participants will:

* Undergo a screening process (D-30 to D-3) and baseline evaluation to ensure eligibility, including confirmation of CD19-positive disease.
* Receive a single intravenous infusion of GI001 at one of four designated dose levels (1E8, 3E8, 7E8 or 1E9 TU) following an "Accelerated Titration" and "3+3" dose-escalation design.
* Remain hospitalized for at least 14 days post-infusion for intensive safety monitoring, specifically for Cytokine Release Syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS).
* Provide multiple blood, saliva, and urine samples for pharmacokinetic (PK), pharmacodynamic (PD), and exploratory analysis (including immunogenicity and viral shedding).
* Participate in efficacy and safety follow-ups through Month 24, followed by a long-term safety follow-up for up to 15 years.

Conditions

  • B-Cell Non-Hodgkin Lymphoma

Interventions

BIOLOGICAL

GI001 Injection

Biological: GI001 Injection GI001 is an innovative chimeric antigen receptor T-cell (CAR-T) therapy targeting CD19-positive B-cell malignancies. Administration: Subjects will receive a single dose of GI001 via intravenous (IV) infusion on Day 0. Dosing Logic: The study follows a dose-escalation design with four pre-specified dose levels: 1E8, 3E8, 7E8, and 1E9 Transducing Units (TU). The dosage is determined based on the total TU count as measured by flow cytometry. Pre-medication: Prior to infusion, subjects may receive pre-conditioning (lymphodepletion chemotherapy) as per protocol and prophylactic medication (e.g., promethazine or diphenhydramine) to prevent infusion reactions.

Sponsors & Collaborators

  • Ruijin Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-20
Primary Completion
2026-07-20
Completion
2029-04-20

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07584850 on ClinicalTrials.gov