Status:
NOT_YET_RECRUITING
First in Human Study of the Infusion of ARI0003 Cells in Relapsed/Refractory to Treatment B-cell Aggressive Lymphoma
Lead Sponsor:
Fundacion Clinic per a la Recerca Biomédica
Conditions:
Refractory Non-Hodgkin Lymphoma
Relapsed Non-Hodgkin Lymphoma
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 15 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06097455
Start Date
January 15 2024
End Date
January 15 2027
Last Update
October 26 2023
Active Locations (7)
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1
CHU Santiago de Compostela
Santiago de Compostela, A Coruña, Spain
2
Hospital Clínic Barcelona
Barcelona, Spain, 08036
3
H. Ramon y Cajal
Madrid, Spain
4
H.U. Virgen de la Arrixaca
Murcia, Spain