GB5005 CART-cell Injection in the Treatment of Patients With CD19-positive RR B-NHL

Sponsor
The First Affiliated Hospital of Xiamen University
Study ID
NCT06875063
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • GB5005 CART — DRUG
    Included patients will receive GB5005 chimeric antigen receptor T-cell injection: A sterile syringe will be used to draw the assigned dose volume (calculated based on the patient's weight and converted to volume). The cells will be slowly infused intravenously at a rate of about 10 mL/min.

Study Details

To evaluate the safety and tolerability of GB5005 in patients with CD19-positive relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL).

Key Dates

First listed
Mar 13, 2025
Start date
Apr 30, 2026
Status verified
Mar 2026
Primary completion
May 31, 2026
Completion
May 31, 2027

Study Design

Enrollment
45 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Low dose group
    GB5005 chimeric antigen receptor T-cell injection（1 × 10 \^ 6 cells/kg）
  • Experimental: Median dose group
    GB5005 chimeric antigen receptor T-cell injection（2 × 10 \^ 6 cells/kg）
  • Experimental: Medium to high dose group
    GB5005 chimeric antigen receptor T-cell injection（3 × 10 \^ 6 cells/kg）
  • Experimental: High dose group
    GB5005 chimeric antigen receptor T-cell injection（5 × 10 \^ 6 cells/kg）

Primary Outcome Measure

Complete remission (CR) [ Time Frame: Up to 3 months ]

Central Contacts

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