Chimeric Antigen Receptor Natural Killer Cell Therapy for High-risk Lymphoma Patients With Primary Sjogren's Syndrome

This study is a phase I-II clinical trial of CAR-NK cell therapy for high-risk lymphoma patients with primary Sjogren's syndrome (pSS). The aim is to determine the optimal dose of CAR-NK cells and evaluate the safety and efficacy of increasing doses of iC9/CAR19/IL15 CB-NK cell therapy. Use i3+3 based design to increase dosage. Dose limiting toxicity (DLT) is defined as the occurrence of CRS within 2 weeks after cell infusion, requiring transfer to the intensive care unit, or grade III-IV acute graft-versus-host disease within 40 days after infusion, or grade 3-5 allergic reactions related to

Trial Details

NCT ID
NCT06967038
Phase
PHASE1 / PHASE2
Sponsor
Bangdong Gong
Status
RECRUITING
Cancer Type
Lymphoma
Interventions
  • CAR-NK cell
Locations (sample)
  • Shanghai, Shanghai Municipality, China|31.22222,121.45806

Key Eligibility Criteria

  • Age range of 18-70 years old, gender not limited;
  • Diagnosed with primary Sjogren's syndrome, meeting the 2016 ACR/EULAR classification criteria;
  • Persistent enlargement of salivary glands, lymph nodes, liver, or spleen (imaging/or pathology), and at least 2 of the following 4 conditions are m…
  • Liver and kidney function, defined as S serum GPT\<3 times the upper limit of normal; Serum bilirubin and alkaline phosphatase are less than twice …

For full eligibility, visit ClinicalTrials.gov.

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