CAR20(NAP)-T therapy for B-cell lymphoma
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)
This study is testing a new treatment that uses modified immune cells to help people with B-cell lymphoma fight their cancer better, especially for those who haven't had success with other treatments.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Sex | All |
| Sponsor | Uppsala University Academic / other |
| Drugs / interventions | tocilizumab, CAR T, CAR-T, chimeric antigen receptor, chemotherapy, cyclophosphamide, fludarabine |
| Locations | 2 sites (Stockholm and 1 other locations) |
| Trial ID | NCT06002659 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults with relapsed or refractory CD20+ B-cell lymphoma who have received at least two lines of therapy and are not eligible for CD19-directed CAR T cell treatment.
Not a fit: Patients with B-cell lymphoma who are not CD20 positive or who have not undergone prior therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a new treatment option for patients with relapsed or refractory B-cell lymphoma who have limited alternatives.
How similar studies have performed: Other studies targeting CD20 in B-cell malignancies have shown promise, but the specific approach of using CAR20(NAP)-T is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * Signed informed consent. * Relapsed or refractory CD20+ diffuse large B-cell lymphoma, mantle cell lymphoma or indolent lymphoma. * The patient should have been treated with at least two lines of therapy and have no curative treatment option, specifically * Relapsed or refractory CD20+ B-cell lymphoma that are not eligible to receive clinically approved CD19-directed CAR T cell treatment. * Relapsed or refractory CD20+ B-cell lymphoma who are CD19 negative. * Relapsed or refractory B-cell lymphoma who relapse after CD19 CAR T cell treatment. * In phase I age \>18 years, in phase II all ages * Measurable disease per Lugano classification. * Performance status ECOG 0-2. * Adequate bone marrow function as evidenced by: * Absolute neutrophil count (ANC) ≥ 1x10\^9/l/L * Platelet ≥ 50x 10\^9/l * Absolute lymphocyte count ≥ 0,1x10\^9/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 for administration of IMP. * Fertile individuals must consent to use contraceptives during participation in the trial. Exclusion Criteria: * Other CD20-positive lymphomas i.e 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 perform 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 this trial is running
Stockholm and 1 other locations
- Karolinska University Hospital — Stockholm, Sweden (Active_not_recruiting)
- Uppsala University Hospital — Uppsala, Sweden (Recruiting)
Study contacts
- Study coordinator: Gunilla Enblad, MD/PhD
- Email: gunilla.enblad@igp.uu.se
- Phone: +46186110000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.