This trial is a phase I/II trial to assess safety, dose finding and feasibility of ex vivo generated MB-CART20.1 cells in patients with relapsed or refractory CD20 positive B-NHL.
MB-CART20.1 consists of autologous Anti-CD20 Chimeric Antigen Receptor (CAR) transduced CD4 /CD8 enriched T cells targeting CD20-positive tumor cells in Non-Hodgkin-Lymphoma (NHL)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
MB-CART20.1 consists of autologous CD20 Chimeric Antigen Receptor (CAR) transduced CD4 /CD8 enriched T cells targeting CD20-positive tumor cells in NHL
University Hospital of Cologne - Clinic for Internal Medicine I
Cologne, Germany
Universitätsklikum Leipzig, AöR
Leipzig, Germany
Phase I - Determination of the maximum tolerated dose (MTD)
MTD is defined as the highest dose level at which \< 33% of patients experience Dose Limiting Toxicity (DLT). Safety and toxicity assessment of MB-CART20.1 per adverse events (AE) reporting classified according to CTCAE version 5.0.
Time frame: until day 28 after infusion of MB-CART20.1
Phase II - Best overall response rate
Response (Complete response (CR), Partial response (PR), Stable disease (SD), Progressive disease (PD)) is defined according to Cheson criteria.
Time frame: 3 months after infusion of MB-CART20.1
Phase I - Related safety and toxicity of MB-CART20.1
Per adverse events (AE) reporting classified according to CTCAE version 5.0.
Time frame: months 3, 6, 9 and 12 after infusion of MB-CART20.1
Phase I - Best overall response rate over 4 weeks and 3 months
Response (CR, PR, SD and PD) is defined according to Cheson criteria.
Time frame: 4 weeks and 3 months after infusion of MB-CART20.1
Phase I - Best overall response rate over 1 year
Response (CR, PR, SD and PD) is defined according to Cheson criteria.
Time frame: 1 year after infusion of MB-CART20.1
Phase I - Occurrence of B-cell aplasia
Circulating B cell numbers in the peripheral blood will be assessed by Flow cytometry.
Time frame: 1 year after infusion of MB-CART20.1
Phase I - Phenotype and Persistence of MB-CART20.1
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Blood samples for determination of persistence/phenotyping of infused MB-CART20.1 will be analysed.
Time frame: 1 year after infusion of MB-CART20.1
Phase II - Best overall response rate over 1 year
Response (CR, PR, SD and PD) is defined according to Cheson criteria.
Time frame: 1 year after infusion of MB-CART20.1
Phase II - Overall response rate over 4 weeks and 3 months
Response (CR, PR, SD and PD) is defined according to Cheson criteria.
Time frame: 4 weeks and 3 months after infusion of MB-CART20.1
Phase II - Overall response rate over 1 year
Response (CR, PR, SD and PD) is defined according to Cheson criteria.
Time frame: 1 year after infusion of MB-CART20.1
Phase II - Number of patients with CR, PR, SD and PD
Response (CR, PR, SD and PD) is defined according to Cheson criteria.
Time frame: 1 year after infusion of MB-CART20.1
Phase II -Percentage of patients with CR, PR, SD and PD
Response (CR, PR, SD and PD) is defined according to Cheson criteria.
Time frame: 1 year after infusion of MB-CART20.1
Phase II - Safety and toxicity assessment of MB-CART20.1
Per adverse events (AE) reporting classified according to CTCAE version 5.0.
Time frame: 1 year after infusion of MB-CART20.1
Phase II - Occurrence of B-cell aplasia
Circulating B cell numbers in the peripheral blood will be assessed by Flow cytometry.
Time frame: 1 year after infusion of MB-CART20.1
Phase II - Phenotype and Persistence of MB-CART20.1
Blood samples for determination of persistence/phenotyping of infused MB-CART20.1 will be analysed.
Time frame: 1 year after infusion of MB-CART20.1