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Recruiting
NCT06002659
CAR20(NAP)-T Therapy for B Cell Lymphoma (CARMA-01 Study)
Conditions: B-cell Lymphoma
Sex: All
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 18
Sponsor: Uppsala University
Location: Karolinska University Hospital Stockholm
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 \
Source: ClinicalTrials.gov (NCT06002659). StuddyBuddy aggregates publicly available trial information.