CAR20(NAP)-T therapy for B-cell lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of CAR20(NAP)-T therapy in patients with B-cell malignancies. The therapy involves engineering a patient's T cells to express a chimeric antigen receptor that targets CD20, aiming to enhance the immune response against tumor cells. By secreting a bacterial-derived immune-stimulating factor, NAP, the treatment seeks to counteract antigen escape and improve therapeutic outcomes for patients who have not responded to existing therapies.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* Signed informed consent.
* Relapsed or refractory CD20+ large B-cell lymphoma (DLBCL, NOS or high-grade malignant B-cell lymphoma), mantle cell lymphoma or indolent lymphoma.
* The patient should have been treated with at least one line of therapy and have no curative treatment option, assessed by the Investigator and documented in the source data prior to enrolment, specifically:

  1. Relapsed or refractory CD20+ B-cell lymphoma that are not suitable to receive clinically approved CD19-directed CAR T cell treatment
  2. Relapsed or refractory CD20+ B-cell lymphoma who are considered CD19 neg-ative
  3. Relapsed or refractory B-cell lymphoma who relapse after CD19-directed CAR T cell treatment
  4. Not suitable for autologous stem cell transplant
  5. Relapsed after allogeneic transplantation
* In phase I age \>18 years, in phase II all ages.
* Measurable disease per Lugano classification.
* Performance status ECOG 0-2.
* Bone marrow function, if impairment is not caused by lymphoma infiltration, as evidenced by:

  1. Absolute neutrophil count (ANC) ≥ 1x109/L
  2. Platelet ≥ 50x 109/L
  3. Absolute lymphocyte count ≥ 0.1x109/L
* Adequate renal, hepatic, cardiac, and pulmonary function as evidenced by:

  1. Creatinine clearance (Cockcroft Gault) ≥ 30 mL/min
  2. Serum Alanine aminotransferase/Aspartate aminotransferase (ALT/AST) ≤ 2.5 Upper limit of normal (ULN) and S-Bilirubin \<1.5x UNL
  3. Cardiac ejection fraction ≥ 40%
* Functional venous access for administration of IMP.
* Fertile individuals must consent to use contraceptives during participation in the trial.

Exclusion Criteria:

* Other CD20-positive lymphomas e.g Burkitt lymphoma, primary CNS lymphoma, plasmablastic lymphoma or CLL transformed to DLBCL/HGBL (Richter transformation)
* Any significant medical or psychiatric illness that would prevent the subject from giving informed consent or from following the study procedures.
* Known human immunodeficiency virus (HIV) infection.
* Impending organ-compromising disease.
* Rapidly progressing disease
* Active and/or severe infection (e.g., tuberculosis, sepsis and opportunistic infections, active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection.
* Other serious underlying medical conditions, which, in the Investigator's judgment, could impair the ability of the subject to tolerate the treatment.
* Treatment with an investigational product within 30 days prior to enrolment
* Potential sign of hypersensitivity reaction to tocilizumab or any of the agents used in this study
* Systemic corticosteroid treatment (\>10mg/day) \<5 days prior to IMP treatment or \<7 days prior leukapheresis.
* Pregnancy

Where it's running

• Karolinska University Hospital
  Stockholm, Sweden Recruiting
• Uppsala University Hospital
  Uppsala, Sweden Recruiting

Study contacts

• Study coordinator: Gunilla Enblad, MD/PhD
• Email: gunilla.enblad@igp.uu.se
• Phone: +46186110000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.