CAR20(NAP)-T Therapy for B Cell Lymphoma (CARMA-01 Study)
CARMA-01
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)
2 other identifiers
interventional
18
1 country
2
Brief Summary
The purpose is to study the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of CAR20(NAP)-T for patients with B-cell malignancies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started May 2024
Typical duration for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 6, 2023
CompletedFirst Posted
Study publicly available on registry
August 21, 2023
CompletedStudy Start
First participant enrolled
May 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2027
May 9, 2024
May 1, 2024
3.7 years
January 6, 2023
May 7, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Incidence of dose limiting toxicity
The incidence of dose limiting toxicity (DLT). Number of Participants Experiencing Adverse Events (AEs) Defined as Dose Limiting Toxicities (DLTs)
First infusion up to 30 days
Adverse events
The nature, frequency, severity, and tolerability of adverse events (AEs) including clinically significant laboratory data, and their relation to dosage.
24 months
Pharmacodynamic (PD) and pharmacokinetic (PK)
PD is assessed by determine circulating B cell level; PK is assessed by determine circulating CAR20(NAP)-T cells.
Either 24 month or 15 years during long-term follow up if clinically indicated
Secondary Outcomes (5)
Objective response rate [ORR]
24 months
Progression free survival [PFS]
24 months
Best Objective Response
24 months
Duration of Response (DOR)
24 months
Overall Survival (OS)
either 24 months or 15 years during long-term follow up if clinically indicated
Other Outcomes (2)
Anti-NAP response
either 24 months or 15 years during long-term follow up if clinically indicated
Bystander immunity activation
either 24 months or 15 years during long-term follow up if clinically indicated
Study Arms (1)
Treatment
EXPERIMENTALCAR20(NAP)-T treatment
Interventions
Autologous CAR-T cells targeting CD20 and upon target recognition express and secrete NAP
Eligibility Criteria
You may qualify if:
- 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
- +4 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Uppsala Universitylead
- Elicera Therapeuticscollaborator
- Uppsala University Hospitalcollaborator
- Karolinska University Hospitalcollaborator
Study Sites (2)
Karolinska University Hospital
Stockholm, Sweden
Uppsala University Hospital
Uppsala, Sweden
Related Publications (1)
Jin C, Ma J, Ramachandran M, Yu D, Essand M. CAR T cells expressing a bacterial virulence factor trigger potent bystander antitumour responses in solid cancers. Nat Biomed Eng. 2022 Jul;6(7):830-841. doi: 10.1038/s41551-022-00875-5. Epub 2022 Apr 4.
PMID: 35379957BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Di Yu, PhD
Uppsala University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 6, 2023
First Posted
August 21, 2023
Study Start
May 1, 2024
Primary Completion (Estimated)
December 30, 2027
Study Completion (Estimated)
December 30, 2027
Last Updated
May 9, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share