CAR20(NAP)-T Cell Therapy Tested in Relapsed B Cell Lymphoma
Tests CAR20(NAP)-T cell therapy in adults with returned or non-responding B cell lymphoma.
Plain-language title generated from the registry record
Registry title: CAR20(NAP)-T Therapy for B Cell Lymphoma (CARMA-01 Study)
Key facts
- Where
- Huddinge and Uppsala, SwedenSee the 2 sites
- Phase
- Phase 1/2
Where in Sweden
- Karolinska University HospitalHuddinge, SwedenTaking people
- Uppsala University HospitalUppsala, SwedenTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Uppsala University
- Trial code
- NCT06002659EU 2024-511844-18-00
- Record updated
- 10 November 2026
- Original description
The purpose is to study the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of CAR20(NAP)-T for patients with B-cell malignancies.Read full original descriptionShow less
A Phase I/IIa Multicenter Study Evaluating the Safety and Efficacy of CAR20(NAP)-T in Patients With Relapsed/Refractory B Cell Lymphoma (CARMA-01 Study)
The purpose is to study the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of CAR20(NAP)-T for patients with B-cell malignancies.
Inclusion: 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:; Relapsed or refractory CD20+ B-cell lymphoma that are not suitable to receive clinically approved CD19-directed CAR T cell treatment; Relapsed or refractory CD20+ B-cell lymphoma who are considered CD19 neg-ative; Relapsed or refractory B-cell lymphoma who relapse after CD19-directed CAR T cell treatment; Not suitable for autologous stem cell transplant; 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:; Absolute neutrophil count (ANC) ≥ 1x109/L; Platelet ≥ 50x 109/L; Absolute lymphocyte count ≥ 0.1x109/L; Adequate renal, hepatic, cardiac, and pulmonary function as evidenced by:; Creatinine clearance (Cockcroft Gault) ≥ 30 mL/min; Serum Alanine aminotransferase/Aspartate aminotransferase (ALT/AST) ≤ 2.5 Upper limit of normal (ULN) and S-Bilirubin <1.5x UNL; Cardiac ejection fraction ≥ 40%; Functional venous access for administration of IMP; Fertile individuals must consent to use contraceptives during participation in the trial.
Exclusion: Treatment with an investigational product within 30 days prior to enrolment; Systemic corticosteroid treatment (>10mg/day) <5 days prior to IMP treatment or <7 days prior leukapheresis; 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; Potential sign of hypersensitivity reaction to tocilizumab or any of the agents used in this study; Other CD20-positive lymphomas e.g Burkitt lymphoma, primary CNS lymphoma, plasmablastic lymphoma or CLL transformed to DLBCL/HGBL (Richter transformation); Pregnancy.