A phase II non-inferiority study comparing point-of-care produced CAR T-cell to commercial CAR T-cells in patients with relapsed/refractory Non-Hodgkin Lymphoma

A phase II non-inferiority study comparing point-of-care produced CAR T-cell to commercial CAR T-cells in patients with relapsed/refractory Non-Hodgkin Lymphoma - HOVON 161 CAR T

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54144

Enrollment

300

Registered

2021-09-07

Start date

2022-10-18

Completion date

Unknown

Last updated

2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Hodgkin Lymphoma

Interventions

Patients are randomized between treatment with - PoC CAR T-cell (ARI-0001) - SoC CAR T-cell (Axi-cel)

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Histologically confirmed DLBCL and associated subtypes, defined by WHO 2016 classification: DLBCL not otherwise specified (NOS), High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology (DHL/THL) and FL3B, T-cell/histocyte rich B-cell lymphoma, Primary mediastinal B-cell lymphoma, EBV+ DLBCL, transformed lymphoma (transformed follicular) and R/R after at least 2 lines of systemic therapy • Age >= 18 years • ECOG/WHO performance status >2 • Secondary central nervous system (CNS) involvement is allowed however, then he/she must have - No signs or symptoms of CNS involvement that would hamper adequate ICANS assessment • Estimated life expectancy of >3 months other than primary disease • Patients of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study and for four months after receiving the preparative regimen • Signed and dated informed consent before conduct of any trial-specific procedure • Patient is capable of giving informed consent

Exclusion criteria

Exclusion criteria: • Absolute neutrophil count (ANC) =2 or LVEF 5 x institutional ULN, unless directly attributable to the lymphoma or Gilbert disease • GFR

Design outcomes

Primary

Measure	Time frame
• PFS from date of IMP infusion (if applicable)	—

Secondary

Measure	Time frame
• PFS from date of randomization • Safety and toxicity assessment of ARI-0001 CAR T-cells and Axi cel per AE reporting classified according to CTCAE Version 5 and CRS and ICANS classified according to the ASTCT criteria • Overall response rate (ORR, sum of CR and PR), as well as CR, PR, SD and PD/relapse at 4 weeks, 12 weeks, 6, 12 and 24 months after infusion of CAR T-cells • Best overall response (BOR) rate at 4 weeks, 12 weeks, 6, 12 and 24 months after infusion of CAR T-cells • Duration of response (DOR) • OS from date of randomization, and from date of CAR T-cell infusion (if applicable) • Patient Reported Outcome/Quality of Life (PRO/QOL) • CAR T-cell expansion, persistence, and T-cell characteristics in both treatment arms (ARI-0001 vs Axi-cel) • PoC CAR T-cell production characteristics (e.g. number of viable T-cells, transduction efficiency, T-cell subsets (activated T-cells, memory T-cells)), including the functional characteristics (e.g. potency tests) between the different production sites • The association of the functional characteristics (e.g. potency tests) of the CAR T-cell products (ARI-0001 CAR T-cells) with CAR T-cell expansion, persistence, adverse events, response rates and progression free survival. • Proportion of successful batches between the different production sites • Number of days between leukapheresis and infusion of CAR T-cells (vein-to-vein time) • Fludarabine pharmacokinetics.	—

Measure

Time frame

• PFS from date of randomization • Safety and toxicity assessment of ARI-0001 CAR T-cells and Axi cel per AE reporting classified according to CTCAE Version 5 and CRS and ICANS classified according to the ASTCT criteria • Overall response rate (ORR, sum of CR and PR), as well as CR, PR, SD and PD/relapse at 4 weeks, 12 weeks, 6, 12 and 24 months after infusion of CAR T-cells • Best overall response (BOR) rate at 4 weeks, 12 weeks, 6, 12 and 24 months after infusion of CAR T-cells • Duration of response (DOR) • OS from date of randomization, and from date of CAR T-cell infusion (if applicable) • Patient Reported Outcome/Quality of Life (PRO/QOL) • CAR T-cell expansion, persistence, and T-cell characteristics in both treatment arms (ARI-0001 vs Axi-cel) • PoC CAR T-cell production characteristics (e.g. number of viable T-cells, transduction efficiency, T-cell subsets (activated T-cells, memory T-cells)), including the functional characteristics (e.g. potency tests) between the different production sites • The association of the functional characteristics (e.g. potency tests) of the CAR T-cell products (ARI-0001 CAR T-cells) with CAR T-cell expansion, persistence, adverse events, response rates and progression free survival. • Proportion of successful batches between the different production sites • Number of days between leukapheresis and infusion of CAR T-cells (vein-to-vein time) • Fludarabine pharmacokinetics.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)