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NCT05583149

Acalabrutinib + Liso-Cel In R/R Aggressive B-Cell Lymphomas

Active, enrolled Phase 2 Results posted Last updated 29 January 2026
What this trial tests

Phase 2 trial testing ACALABRUTINIB in Refractory Aggressive B-cell Lymphomas in 28 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
1 March 2023
Primary endpoint
23 November 2024
1 March 2029

Quick facts

Lead sponsorPatrick C. Johnson, MD
PhasePhase 2
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment28
Start date1 March 2023
Primary completion23 November 2024
Estimated completion1 March 2029
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Patrick C. Johnson, MD

Who can join

18 and older, any sex, with Refractory Aggressive B-cell Lymphomas or Refractory B-Cell Non-Hodgkin Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Complete Response Rate (CRR) Primary · 1 year 8 months

The CRR is defined as the percentage of subjects achieving an objective response of complete response (CR) according to the Lugano Classification (Chesson et al., 2014), prior to start of another non-study anticancer therapy. CR is defined as a complete metabolic and radiologic response (Lugano score 1-3, target nodes/nodal masses must regress to ≤ 1.5 cm in longest diameter.)

GroupValue95% CI
ACALABRUTINIB and LISOCABTAGENE MARALEUCEL22

Adverse events — posted to ClinicalTrials.gov

Time frame: All adverse events are reported from the start of acalabrutinib until 30 days after the last dose of study drug or at documented disease progression, whichever is longer. For patients without disease progression at 90 days after the last dose of study drug, only adverse events at least possibly related to study drug are reported through year 2 or disease progression, whichever occurs first (adverse events followed up to 24 months in a single patient as of November 2025.). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

ACALABRUTINIB and LISOCABTAGENE MARALEUCEL
Serious: 7/27 (26%)
Deaths: 0/27

Serious adverse events (8 terms)

ReactionSystemACALABRUTINIB and LISOCABT…
FeverGeneral disorders
Alanine aminotransferase increasedInvestigations
Aspartate aminotransferase increasedInvestigations
Cytokine Release SyndromeInvestigations
HypercalcemiaMetabolism and nutrition disorders
HypotensionVascular disorders
NauseaGastrointestinal disorders
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specifyNeoplasms benign, malignant and unspecified (incl cysts and polyps)
Other adverse events (190 terms — click to expand)

ReactionSystemACALABRUTINIB and LISOCABT…
FatigueGeneral disorders
NauseaGastrointestinal disorders
Neutrophil count decreasedInvestigations
Cytokine release syndromeImmune system disorders
ConstipationGastrointestinal disorders
DehydrationMetabolism and nutrition disorders
DizzinessNervous system disorders
CoughRespiratory, thoracic and mediastinal disorders
HeadacheNervous system disorders
PainGeneral disorders
DiarrheaGastrointestinal disorders
HypotensionVascular disorders
HypertensionVascular disorders
FeverGeneral disorders
Pain in extremityMusculoskeletal and connective tissue disorders
AnorexiaMetabolism and nutrition disorders
Back painMusculoskeletal and connective tissue disorders
Gastroesophageal reflux diseaseGastrointestinal disorders
Febrile neutropeniaBlood and lymphatic system disorders
HypokalemiaMetabolism and nutrition disorders
HypophosphatemiaMetabolism and nutrition disorders
Nasal congestionRespiratory, thoracic and mediastinal disorders
DyspneaRespiratory, thoracic and mediastinal disorders
Edema limbsGeneral disorders
HyperlipidemiaMetabolism and nutrition disorders
HypomagnesemiaMetabolism and nutrition disorders
HyponatremiaMetabolism and nutrition disorders
InsomniaPsychiatric disorders
AnemiaBlood and lymphatic system disorders
Infections and infestations - Other, specifyInfections and infestations
Lung infectionInfections and infestations
Sore throatRespiratory, thoracic and mediastinal disorders
TremorNervous system disorders
Urinary incontinenceRenal and urinary disorders
VomitingGastrointestinal disorders
Abdominal PainGastrointestinal disorders
Alanine aminotransferase increasedInvestigations
ArthritisMusculoskeletal and connective tissue disorders
Aspartate aminotransferase increasedInvestigations
BruisingInjury, poisoning and procedural complications

Most-reported serious reactions: Fever, Alanine aminotransferase increased, Aspartate aminotransferase increased, Cytokine Release Syndrome, Hypercalcemia, Hypotension, Nausea, Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify.

Data from ClinicalTrials.gov NCT05583149 adverse events section.

Sponsor's own description

This research is being done to assess the effectiveness and safety of acalabrutinib combined with lisocabtagene maraleucel (liso-cel) for people with relapsed/refractory aggressive B-cell lymphoma. This research study involves the study drug acalabrutinib in combination with lisocabtagene maraleuce

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. CAR-T cell therapy for cancer: current challenges and future directions.
    Zugasti I, Espinosa-Aroca L, Fidyt K, Mulens-Arias V, et al · · 2025 · cited 81× · PMID 40610404 · DOI 10.1038/s41392-025-02269-w
  2. Targeting MYC-driven lymphoma: lessons learned and future directions.
    Martínez-Martín S, Beaulieu ME, Soucek L. · · 2023 · cited 11× · PMID 37457123 · DOI 10.20517/cdr.2022.127
  3. Immune checkpoint blockade and CAR T-cell therapy in T-cell/histiocyte-rich large B-cell lymphoma: Challenges and opportunities.
    Sahin TK, Akin S. · · 2024 · cited 8× · PMID 39328551 · DOI 10.1016/j.heliyon.2024.e38023
  4. Updates on Chimeric Antigen Receptor T-Cells in Large B-Cell Lymphoma.
    Saleh K, Khalife N, Arbab A, Khoury R, et al · · 2024 · cited 2× · PMID 39767716 · DOI 10.3390/biomedicines12122810
  5. Adoptive T‐cell therapies in the clinic
    Shaha S, Lourenco L, Zhao Z, Mitragotri S. · · 2025

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Trials by the same sponsor.

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing