Our Pipeline

Hematologic Malignancies

Monotherapy Clinical Development

Phase 01

Multiple myeloma (MM)

NCT02211014: acalabrutinib +/- dexamethasone
R/R MM

Diffuse large B-cell lymphoma (DLBCL) (recruitment complete)

NCT02112526: acalabrutinib +/- rituximab
R/R de novo ABC DLBCL

Phase 02

Chronic lymphocytic leukemia (CLL)
Small lymphocytic lymphoma (SLL)

NCT02717611: acalabrutinib
R/R Ibrutinib intolerant CLL

Chronic lymphocytic leukemia (CLL)
Small lymphocytic lymphoma (SLL)

NCT02337829: acalabrutinib
Treatment naïve and R/R Del 17p CLL/SLL

Chronic lymphocytic leukemia (CLL)
Small lymphocytic lymphoma (SLL)
(recruitment complete)

NCT02029443: acalabrutinib first-in-human study
Treatment naïve and R/R CLL

Mantle cell lymphoma (MCL)
(recruitment complete)

NCT02213926: acalabrutinib
R/R MCL

Waldenström macroglobulinemia (WM) (recruitment complete)

NCT02180724: acalabrutinib
R/R WM

Phase 03

Chronic lymphocytic leukemia (CLL)
Small lymphocytic lymphoma (SLL)

NCT02477696: acalabrutinib vs ibrutinib
R/R CLL

Chronic lymphocytic leukemia (CLL) small lymphocytic leukemia

NCT02970318: acalabrutinib vs investigator's choice of idelalisib + rituximab or bendamustine + rituximab in R/R CLL

Combination Clinical Development

Phase 01 

Mantle cell lymphoma (MCL)

NCT02717624: acalabrutinib + (bendamustine or venetoclax) + rituximab
Treatment naïve and R/R MCL

Non-Hodgkins Lymphoma (NHL)

NCT02180711: acalabrutinib +/- rituximab
R/R FL

NCT02180711: acalabrutinib +/- rituximab (TN and R/R FL)

NCT02180711: acalabrutinib +/- rituximab (R/R MZL)

NCT02180711: acalabrutinib + rituximab + lenalidomide (R/R FL)

NCT02180711: acalabrutinib + rituximab + lenalidomide (R/R DLBCL)

Chronic lymphocytic leukemia (CLL)
Small lymphocytic lymphoma (SLL) (recruitment complete)

NCT02157324: acalabrutinib + ACP-319
R/R CLL

NCT02296918: acalabrutinib + obinutuzumab
Previously Untreated CLL and R/R CLL/SLL/PLL

Phase 02 

Other hematologic malignancies

NCT02362035: acalabrutinib + pembrolizumab
Hematologic malignancies

NCT02328014: acalabrutinib + ACP-319
B-cell malignancies

Phase 03 

Chronic lymphocytic leukemia (CLL)
Small lymphocytic lymphoma (SLL)

NCT02475681: acalabrutinib vs acalabrutinib + obinutuzumab vs obinutuzumab + clb
Treatment naïve CLL

Previously Untreated CLL

NCT03836261: acalabrutinib + venetoclax +/- obinutuzumab vs chemoimmunotherapy

Mantle Cell Lymphoma

NCT02972840: bendamustine and rituximab alone vs in combination with acalabrutinib in subjects with previously untreated mantle cell lymphoma

Acerta Pharma is also conducting multiple healthy volunteer trials and planning additional combination trials in conjunction with AstraZeneca targeted inhibitors.

The information provided here regarding acalabrutinib is for indications that are currently under investigation.

Acalabrutinib is an investigational product and as such is not approved by the US Food and Drug Administration, European Medicines Agency or any other regulatory agency for the uses under investigation.