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Comparison of Point-of-care Produced CAR T-cell with Commercial CAR T-cells in Patients with R/R LBCL

ConditionsNHLDLBCL - Diffuse Large B Cell Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Medical Center Groningen

About this trial

A phase II, multi-center study to compare the feasibility, and clinical efficacy of local manufacturing of CD19-directed CAR T-cells (ARI-0001 CAR T-cells) with commercial produced CAR T-cells (for example axicabtagene ciloleucel, a CD19 targeting commercially available CAR T-cell) in patients with relapsed or refractory (R/R) DLBCL.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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, transformed lymphoma (transformed follicular) and R/R after at least 2 lines of systemic therapy

Age ≥ 18

Eastern Cooperative Oncology Group (ECOG)/WHO performance status 0-2

Secondary central nervous system (CNS) involvement is allowed however, then he/she must have

Disqualifiers

Absolute neutrophil count (ANC) <1.0x10^9/L

Platelet count <50x10^9/L

Absolute lymphocyte count <0.1x10^9/L

Primary CNS lymphoma

Trial design

Design model

Parallel

Treatments tested in this trial

  • ARI-0001

    Drug

    Infusion with a single target dose of 2.0 x 10\^6 Point of Care CAR T-cells/kg BW (range 1 -2.0x 10\^6 CAR T-cells /kg BW).

  • Axi-cel

    Drug

    Infusion with a single target dose of 2.0 x 10\^6 Standard of Care CAR T-cells/kg BW (range 1 -2.0x 10\^6 CAR T-cells /kg BW).

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Arm A (ARI-0001)Experimental treatment 1 intervention
Group B: Arm B (Axi-cel)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Progression-free survival (PFS) from date of IMP infusion (if applicable)

PFS from date of IMP infusion is defined as the time from IMP infusion, until progression, relapse or death from any cause, whichever comes first. PFS reflects tumor growth and, therefore, occurs prior to the endpoint of OS. Progression is defined as the first date of documentation of a new lesion or enlargement of a previous lesion, or the date of the scheduled clinic visit immediately after radiologic assessment has been completed. If there is missing information, censoring of the data may be defined as the last date at which progression status was adequately assessed.

Time frame
Approximately up to 60 months following first patient IMP infusion

Secondary outcomes

1

Progression-free survival (PFS) from date of randomization

PFS from date of randomization is defined as the time from enrollment, until progression, relapse or death from any cause, whichever comes first. PFS reflects tumor growth and, therefore, occurs prior to the endpoint of OS. Progression is defined as the first date of documentation of a new lesion or enlargement of a previous lesion, or the date of the scheduled clinic visit immediately after radiologic assessment has been completed. If there is missing information, censoring of the data may be defined as the last date at which progression status was adequately assessed.

Time frame
Approximately up to 60 months following first patient enrollment
2

Safety and toxicity assessment per AE reporting

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. The number and proportion of patients in the specific safety population with CTCAE grade 2, 3 or 4 (incl. grade 5) will be tabulated by randomization arm. Per site, the maximum observed grade per cycle within a patient will be used.

Time frame
Approximately up to 60 months following first patient IMP infusion
3

Overall Response Rate (ORR)

ORR is the sum of complete response (CR) and partial response (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.

Time frame
At 4 weeks, 12 weeks, 6, 12 and 24 months after infusion of CAR T-cells
4

Expansion of CAR T-cells

Expansion of CAR T-cells will be assessed in both treatment arms. The central lab will collect these data, but the vast majority will not be entered in the ALEA database, and will only be analyzed by the central lab. Further details and analyses will be described in a separate SAP, which will be written by those involved in that specific analysis.

Time frame
Approximately up to 60 months following first patient IMP infusion

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Medical Center Groningen

Lead sponsor

Stichting Hemato-Oncologie voor Volwassenen Nederland

Collaborator

Source ClinicalTrials.gov
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