A Study of Atlacabtagene Autoleucel CAR T-cells for Adults With Relapsed Large B-cell Lymphoma

Recruiting now · Phase 2

Conditions studied: Large B-cell Lymphoma, Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, Primary Mediastinal Large B-cell Lymphoma (PMBCL), Transformed Non-Hodgkin Lymphoma

In brief

The goal of this clinical trial is to learn if a new type of chimeric antigen receptor (CAR) T-cell therapy called atlacabtagene autoleucel is effective and safe for the treatment large B-cell lymphomas (LBCL) that have not responded to or have come back after standard chemotherapy. The main questions this trial aims to answer are: * What is the likelihood of complete response of the lymphoma after atlacabtagene autoleucel treatment? * What is the risk of altered brain function (neurotoxicity) after atlacabtagene autoleucel? All eligible participants will receive atlacabtagene autoleucel; the researchers will compare the complete response rate and neurotoxicity rate with historical groups of patients who were treated with similar therapies. Participants will: * Have a procedure to gather white blood cells * Receive chemotherapy to prepare for the CAR T-cells * Receive atlacabtagene autoleucel CAR T-cells through a vein * Be monitored closely for the first 14 days for certain side effects * Have scans 28 days and 3, 6, 12 and 24 months after atlacabtagene autoleucel CAR T-cells to check if the treatment has worked

Key facts

Study ID: NCT06486051
Run by: Malaghan Institute of Medical Research
People needed: 60
Starts: 2024-07-12
Expected to finish: 2029-06-30
Last updated by the study team: 2026-08-07

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age 18 to 75 years (inclusive) at the time of informed consent
Signed written informed consent for this trial
Biopsy-proven relapsed or treatment-refractory B-cell non-Hodgkin lymphoma of the following subtypes, as per the 2022 WHO classification of haematolymphoid tumours
Large B-cell lymphomas of the following histological subtypes:
Diffuse LBCL, not otherwise specified
Diffuse large B-cell lymphoma/high grade B-cell lymphoma with MYC and BCL2 rearrangements
Large B-cell lymphoma with IRF4 rearrangement
High grade B-cell lymphoma with 11q aberrations
High grade B-cell lymphoma, not otherwise specified
Primary mediastinal large B-cell lymphoma
Follicular large B-cell lymphoma
EBV-positive diffuse large B-cell lymphoma, not otherwise specified
Diffuse large B-cell lymphoma associated with chronic inflammation
Primary cutaneous DLBCL, leg type
Large B-cell lymphoma of one of the above subtypes that has transformed from follicular or marginal zone lymphoma
Received adequate first-line lymphoma therapy for the qualifying histology (as defined in inclusion criterion 3 above), comprising at least 2 cycles of a standard combination regimen incorporating an anthracycline and an anti-CD20 monoclonal antibody
Relapsed or refractory disease meeting one of the following criteria:
Relapsed or refractory within 12 months of first-line chemoimmunotherapy, defined as:
Progressive disease following ≥ 2 cycles of chemoimmunotherapy, or
Stable disease following ≥ 4 cycles of chemoimmunotherapy, or
Partial response following ≥ 6 cycles of chemoimmunotherapy, or
Complete response followed by biopsy-proven relapse within 12 months of completing first-line chemoimmunotherapy.
Relapsed or refractory following second-line chemoimmunotherapy, defined as:
Lack of complete response to, or relapse following, autologous stem cell transplantation as part of second-line therapy for the qualifying histology, or
Inability to proceed to autologous stem cell transplantation due to lack of response to 2 cycles of second-line chemoimmunotherapy incorporating both a platinum agent and an anti-CD20 monoclonal antibody

You may not qualify if…

Active central nervous system (CNS) involvement by lymphoma. In patients with a history of CNS disease or a clinical suspicion of current CNS disease, lumbar puncture and MRI brain must be performed within 30 days of enrolment to exclude current CNS involvement.
Active CNS pathology including: epilepsy, seizure within the preceding year, aphasia, paresis, stroke, dementia, psychosis within the preceding year, severe brain injury, Parkinson disease, or cerebellar disease
B-cell non-Hodgkin lymphoma of the following subtypes, as per the 2022 WHO classification of haematolymphoid tumours:
Richter transformation of chronic lymphocytic leukaemia
T-cell/histiocyte rich LBCL
Primary LBCL of immune-privileged sites
Fluid overload associated LBCL
Fibrin-associated LBCL
Plasmablastic lymphoma
Mediastinal grey zone lymphoma
Intravascular LBCL
ALK-positive large B-cell lymphoma
Lymphomatoid granulomatosis
Burkitt lymphoma
Primary effusion lymphoma
KSHV/HHV8-positive diffuse large B-cell lymphoma
Patient has received 3 or more prior lines of therapy for LBCL, where 1 line of therapy is defined as 1 or more cycles of a combination chemoimmunotherapy with or without pre-planned consolidation therapy (radiotherapy, autologous stem cell transplant or immunotherapy)
Requirement for urgent lymphoma therapy due to tumour-related symptoms, or due to imminent risk of blood vessel, airway, urinary tract, gastrointestinal tract, nerve or spinal cord compression
Active autoimmune disease requiring current systemic immunosuppression
Active sarcoidosis
Prior solid organ transplantation or prior allogeneic stem cell transplantation (allo-SCT)
Peripheral blood CD3+ T cells < 150/μL (0.15 x10\^9/L) as assessed by lymphocyte subset analysis
History of active malignancy other than B-cell malignancy within 2 years prior to enrolment, with the exception of: adequately treated in situ carcinoma of the cervix; adequately treated basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) of the skin; other localised malignancy surgically resected (or radically treated with another treatment modality) with curative intent
Prior treatment with:
gene therapy (including CAR T-cell therapy) or CD19-targeted immunotherapy, or

Where it is running

Auckland City Hospital — Auckland, Auckland, New Zealand (enrolling)
Christchurch Hospital — Christchurch, Christchurch Central, New Zealand (enrolling)
Wellington Hospital — Newtown, Wellington Region, New Zealand (enrolling)

Full record on ClinicalTrials.gov

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