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Trial Title:
First in Human Study of the Infusion of ARI0003 Cells in Relapsed/Refractory to Treatment B-cell Aggressive Lymphoma
NCT ID:
NCT06097455
Condition:
Refractory Non-Hodgkin Lymphoma
Relapsed Non-Hodgkin Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, Non-Hodgkin
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Genetic
Intervention name:
ARI0003
Description:
Treatment with ARI0003 cells
Arm group label:
ARI0003
Other name:
Adult autologous differentiated T-cells from peripheral blood, expanded and co-transduced lentiviruses: one containing a chimeric antigen receptor anti-CD19 and another containing an anti-CD269 (BCMA)
Summary:
ths study consist in testing a CAR T therapy (ARI0003 cells (antiCD19 and antiBCMA) in
patients suffering relapsed NHL (that means that symptoms of NHL reappeared ) or
refractory (that means that they did not respond to other treatments). This is a first in
human study.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
CHU Santiago de Compostela
Address:
City:
Santiago De Compostela
Country:
Spain
Contact:
Last name:
Adrián Mosquera Orgeira, MD
Facility:
Name:
Hospital Clínic Barcelona
Address:
City:
Barcelona
Zip:
08036
Country:
Spain
Contact:
Last name:
Julio Delgado
Phone:
+34932275400
Email:
jdelgado@clinic.cat
Facility:
Name:
H. Ramon y Cajal
Address:
City:
Madrid
Country:
Spain
Contact:
Last name:
Javier Lopez Jiménez, MD
Facility:
Name:
H.U. Virgen de la Arrixaca
Address:
City:
Murcia
Country:
Spain
Contact:
Last name:
Jose M Moraleda, MD PhD
Facility:
Name:
Hospital Central de Asturias
Address:
City:
Oviedo
Country:
Spain
Contact:
Last name:
Jose M Garcia Gala, MD
Facility:
Name:
Hospital Son Espases
Address:
City:
Palma De Mallorca
Country:
Spain
Contact:
Last name:
Leyre Bento de Miguel, MD
Facility:
Name:
H. Clínico de Salamanca
Address:
City:
Salamanca
Country:
Spain
Contact:
Last name:
Fermín Sanchez-Guijo
Start date:
January 15, 2024
Completion date:
January 15, 2027
Lead sponsor:
Agency:
Fundacion Clinic per a la Recerca Biomédica
Agency class:
Other
Source:
Fundacion Clinic per a la Recerca Biomédica
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06097455
