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TCR Reserved and Power3 (SPPL3) Gene Knock-out Allogeneic CD19-targeting CAR-T Cell Therapy in r/r B Cell Lymphoma

TCR Reserved and Power3 (SPPL3) Gene Knock-out Allogeneic CD19-targeting CAR-T Cell Therapy in r/r B Cell Lymphoma

Recruiting
18-70 years
All
Phase 1/2

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Overview

The goal of this clinical trial is to evaluate the immune response to gluten in patients with celiac disease (CeD) by comparing different forms of gluten administration. The participant population includes adults diagnosed with CeD, who are adhering to a gluten-free diet (GFD). The main questions it aims to answer are:

  • Does liquid gluten administration elicit a higher IL-2 cytokine response compared to solid gluten administration?
  • What is the relationship between serum IL-2 levels and gluten peptide serum concentrations following gluten challenges?

Researchers will compare the responses of two groups: participants receiving liquid gluten (shake) to those receiving solid gluten (cookie) to determine if there is a significant difference in the IL-2 response rates between the two forms.

Participants will be asked to:

  • Undergo two gluten challenges (liquid and solid) in a randomized order with at least 4 weeks apart.
  • Provide blood samples before and after each challenge to measure serum IL-2 levels and gluten peptide concentrations over a period of 6 hours.
  • Report any symptoms experienced following each gluten challenge.

Eligibility

Inclusion Criteria:

  • BMI 18-33 kg/m2
  • Willingness to comply with the study procedure and having signed informed, written consent
  • Previous diagnosis of coeliac disease according to established guidelines based on positive serology (Endomysium test, IgA-TG2 and/or IgG-DGP) (diagnosed in childhood) and a duodenal biopsy showing villous atrophy graded as Marsh 3 according to guidelines from European Society for Study of Coeliac Disease .
  • Strict adherence to a gluten-free diet at least the 12 last months.

Exclusion Criteria:

  • Positive serology (IgA-TG2 below upper level of normal) at screening visit
  • Pregnancy or breast feeding. Fertile women must use effective contraception.
  • Other inflammatory disease like uncontrolled hypothyreosis, type 1 diabetes, cardiovascular diseases, thyroid and renal disorders, inflammatory bowel diseases or any other disease that in the opinion of the responsible clinician makes the patient unsuitable for the study
  • Using of immunosuppressive/steroid medications
  • Wheat allergy
  • Severe acute infection

Study details
    Non-hodgkin Lymphoma

NCT06323525

Chinese PLA General Hospital

13 May 2026

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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