Status:
RECRUITING
CAR20(NAP)-T Therapy for B Cell Lymphoma (CARMA-01 Study)
Lead Sponsor:
Uppsala University
Collaborating Sponsors:
Elicera Therapeutics
Uppsala University Hospital
Conditions:
B-cell Lymphoma
Eligibility:
All Genders
Phase:
PHASE1
PHASE2
Brief Summary
The purpose is to study the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of CAR20(NAP)-T for patients with B-cell malignancies.
Detailed Description
A cancer patient's T cells can be isolated and engineered to express a chimeric antigen receptor (CAR), which re-directs the T cells to recognize and kill tumor cells expressing that particular antige...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
May 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2027
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT06002659
Start Date
May 1 2024
End Date
December 30 2027
Last Update
May 9 2024
Active Locations (2)
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1
Karolinska University Hospital
Stockholm, Sweden
2
Uppsala University Hospital
Uppsala, Sweden