NCT06002659 CAR20(NAP)-T Therapy for B Cell Lymphoma (CARMA-01 Study)
| NCT ID | NCT06002659 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Uppsala University |
| Condition | B-cell Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 18 participants |
| Start Date | 2024-05-01 |
| Primary Completion | 2028-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 18 participants in total. It began in 2024-05-01 with a primary completion date of 2028-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose is to study the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of CAR20(NAP)-T for patients with B-cell malignancies.
Eligibility Criteria
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
Contact & Investigator
Di Yu, PhD
STUDY DIRECTOR
Uppsala University
Frequently Asked Questions
Who can join the NCT06002659 clinical trial?
This trial is open to participants of all sexes, studying B-cell Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06002659 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06002659 currently recruiting?
Yes, NCT06002659 is actively recruiting participants. Contact the research team at gunilla.enblad@igp.uu.se for enrollment information.
Where is the NCT06002659 trial being conducted?
This trial is being conducted at Stockholm, Sweden, Uppsala, Sweden.
Who is sponsoring the NCT06002659 clinical trial?
NCT06002659 is sponsored by Uppsala University. The principal investigator is Di Yu, PhD at Uppsala University. The trial plans to enroll 18 participants.