- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06097455
First in Human Study of the Infusion of ARI0003 Cells in Relapsed/Refractory to Treatment B-cell Aggressive Lymphoma (CARTD-BG-1)
First in Human, Pilot, Open-label, Prospective, Multicentre, Non-randomised Clinical Trial to Evaluate the Safety and Efficacy of ARI0003 (CART CD19/ CD269 Cells) in Patients With Relapsed/Refractory B-cell Aggressive Lymphoma
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Early Phase 1
Contacts and Locations
Study Contact
- Name: Julio Delgado, MD PhD
- Phone Number: +34932275400
- Email: jdelgado@clinic.cat
Study Contact Backup
- Name: Sara Varea, MSc
- Phone Number: +34932275400
- Email: svarea@clinic.cat
Study Locations
-
-
-
Barcelona, Spain, 08036
- Hospital Clinic Barcelona
-
Contact:
- Julio Delgado
- Phone Number: +34932275400
- Email: jdelgado@clinic.cat
-
Madrid, Spain
- H. Ramon y Cajal
-
Contact:
- Javier Lopez Jiménez, MD
-
Murcia, Spain
- H.U. Virgen de la Arrixaca
-
Contact:
- Jose M Moraleda, MD PhD
-
Oviedo, Spain
- Hospital Central de Asturias
-
Contact:
- Jose M Garcia Gala, MD
-
Palma De Mallorca, Spain
- Hospital Son Espases
-
Contact:
- Leyre Bento de Miguel, MD
-
Salamanca, Spain
- H. Clínico de Salamanca
-
Contact:
- Fermín Sanchez-Guijo
-
-
A Coruña
-
Santiago De Compostela, A Coruña, Spain
- CHU Santiago de Compostela
-
Contact:
- Adrián Mosquera Orgeira, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
1. Diagnosis of CD19+ or CD269+ relapsed/refractory (R/R) aggressive B-cell lymphoma in one of the following circumstances:
- Burkitt's lymphoma;
- Histology not covered by approved CART19-cell products (plasmablastic lymphoma, primary effusion lymphoma, intravascular lymphoma, transformed lymphoma from marginal zone lymphoma or chronic lymphocytic leukaemia, primary cutaneous DLBCL, T-cell rich DLBCL, high-grade B-cell lymphoma, grey zone lymphoma or grade 3b follicular lymphoma); or
Aggressive B-cell lymphoma that is refractory or relapsing after treatment with CART19-cell therapy.
2. Age older than 18 years. 3. ECOG performance status of 0-2. 4. Estimated life expectancy of at least 3 months. 5. Adequate venous access and absence of contraindications for lymphapheresis. 6. Signature of informed consent. 7. In patients who have received any anti-CD19 or anti-CD269 therapy (e.g. tisagenlecleucel, axicabtagene autoleucel, tafasitamab, loncastuximab, belantamab mafodotin, idecabtagene vicleucel, etc.), a centralised tumour sample confirming the expression of at least one of the antigens (either CD19 or CD269) will be needed at study inclusion
Exclusion Criteria:
1. Any experimental or non-commercialized therapy in the previous 4 weeks. 2. Any other concomitant neoplasia, unless it has been in complete remission for 3 years or longer, except for non-melanoma skin cancer or completely resected in situ carcinoma.
3. Active immunosuppressive therapy except for prednisone 10 mg/day (or equivalent).
4. Active infection requiring systemic medical therapy. 5. Active HBV or HCV infection. 6. Positive serology for HIV. 7. Any concomitant and uncontrolled medical disease. 8. Severe organic impairment defined by cardiac ejection fraction <40%, DLCO <40%, GFR <30 ml/min or bilirubin >3 times the upper limit of normality (unless due to Gilbert's syndrome).
9. Lactating or pregnant women. 10. Men or women of childbearing potential unable or unwilling to use highly efficient contraceptive measures from the beginning until the end of the study.
11. CNS disease in the form of a macroscopic solid lesion in the encephalon or spinal cord (isolated meningeal disease is allowed
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ARI0003
ARI0003 will be administered intravenously under a split regime.
A total dose between 0.5 and 5 x106 cell/Kg will be administered in 3 administrations (fractions):
|
Treatment with ARI0003 cells
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ORR
Time Frame: within 3 months post ARI0003 infusion
|
Overall response rate (ORR) according to Lugano criteria (best response within 3 months post ARI0003 infusion
|
within 3 months post ARI0003 infusion
|
Rate of > grade 3 CRS and/or ICANS
Time Frame: in the first 30 days after ARI0003 administration
|
Rate of patients who develop grade > 3 cytokine release syndrome (CRS) and/or grade > 3 immune cell associated neurotoxicity syndrome (ICANS) according to the criteria and grading defined in the international consensus document of the American Society for Transplantation and Cellular Therapy (ASTCT criteria).
ASTCT score can be between 1 and 4 (being 1 the minimum value and 4 the maximum) and where higher score means worse outcome.
|
in the first 30 days after ARI0003 administration
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Procedure-related mortality (PRM)
Time Frame: through study completion, an average of 24 months
|
Procedure-related mortality (PRM), defined as any death not directly cause by the lymphoma that is related with the procedure.
For the estimation of PRM, disease relapse will be considered as a competing event
|
through study completion, an average of 24 months
|
Toxicity: incidence of AE
Time Frame: at 3 and 12 months
|
Toxicity defined as the incidence of grade >3 adverse events (AEs) as per CTCAE version 5.0.
The following AEs will be considered AEs of special interest (AESI): CRS, ICANS, macrophagic activation syndrome (MAS), tumour lysis syndrome (TLS), prolonged cytopenia (beyond 6 months), infections and second primary malignancies
|
at 3 and 12 months
|
Complete response rate
Time Frame: at 3 months
|
Complete response rate
|
at 3 months
|
Duration of response,
Time Frame: from month 3 to study completion, an average of 24 months
|
Duration of response, calculated from the time of first disease evaluation (3 months);
|
from month 3 to study completion, an average of 24 months
|
Progression-free survival
Time Frame: through study completion, an average of 24 months
|
Progression-free survival, calculated from ARI-0003 cell infusion
|
through study completion, an average of 24 months
|
Overall survival
Time Frame: through study completion, an average of 24 months
|
Overall survival, calculated from ARI-0003 cell infusion
|
through study completion, an average of 24 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CARTD-BG-1
- 2023-5072-13-97-00 (Other Identifier: EU CT)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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