Actively Recruiting
CAR20(NAP)-T Therapy for B Cell Lymphoma (CARMA-01 Study)
Led by Uppsala University · Updated on 2024-05-09
18
Participants Needed
2
Research Sites
191 weeks
Total Duration
On this page
Sponsors
U
Uppsala University
Lead Sponsor
E
Elicera Therapeutics
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose is to study the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of CAR20(NAP)-T for patients with B-cell malignancies.
CONDITIONS
Official Title
CAR20(NAP)-T Therapy for B Cell Lymphoma (CARMA-01 Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Diagnosis of relapsed or refractory CD20-positive diffuse large B-cell lymphoma, mantle cell lymphoma, or indolent lymphoma
- Treated with at least two prior therapies and no curative treatment option
- Not eligible for approved CD19 CAR T cell therapy, or CD19 negative, or relapsed after CD19 CAR T cell treatment
- Age over 18 years for Phase I; all ages eligible for Phase II
- Measurable disease according to Lugano classification
- ECOG performance status of 0 to 2
- Adequate bone marrow function with ANC ≥ 1x10^9/L, platelet count ≥ 50x10^9/L, and absolute lymphocyte count ≥ 0.1x10^9/L
- Adequate kidney function with creatinine clearance ≥ 30 mL/min
- Adequate liver function with ALT/AST ≤ 2.5 times upper limit of normal and bilirubin <1.5 times upper limit
- Cardiac ejection fraction ≥ 40%
- Functional veins for administration of investigational medicinal product
- Fertile individuals agree to use contraception during the trial
You will not qualify if you...
- Other CD20-positive lymphomas such as Burkitt lymphoma, primary CNS lymphoma, plasmablastic lymphoma, or CLL transformed to DLBCL/HGBL (Richter transformation)
- Significant medical or psychiatric illness preventing consent or study compliance
- Known HIV infection
- Organ-compromising disease
- Rapidly progressing disease
- Active or severe infections including tuberculosis, sepsis, opportunistic infections, active hepatitis B or C
- Other serious medical conditions impairing treatment ability
- Use of investigational product within 30 days prior to enrollment
- Possible hypersensitivity to tocilizumab or study agents
- Systemic corticosteroid treatment above 10 mg/day within 5 days before treatment or less than 7 days before leukapheresis
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Karolinska University Hospital
Stockholm, Sweden
Active, Not Recruiting
2
Uppsala University Hospital
Uppsala, Sweden
Actively Recruiting
Research Team
G
Gunilla Enblad, MD/PhD
CONTACT
D
Di Yu, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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