OncoMatch/Clinical Trials/NCT04484012
Modified Immune Cells (CD19 CAR T Cells) and Acalabrutinib for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma
Is NCT04484012 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem-enriched T-lymphocytes and Acalabrutinib for recurrent mantle cell lymphoma.
Treatment: Acalabrutinib · CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem-enriched T-lymphocytes — This phase II trial investigates the side effects of CD19 chimeric antigen receptor (CAR) T cells and acalabrutinib, and to see how well they work in treating patients with mantle cell lymphoma that has come back (relapsed) or does not respond to treatment (refractory). T cells are infection fighting blood cells that can kill cancer cells. The T cells given in this study will come from the patient and will have a new gene put in them that makes them able to recognize CD19, a protein on the surface of the cancer cells. These CD19-specific T cells may help the body's immune system identify and kill CD19 positive cancer cells. Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving CD19 CAR T cells together with acalabrutinib may kill more cancer cells.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD19 positive
Documented CD19+ MCL by flow cytometry or IHC (from biopsy) if prior CD19 directed therapy was previously used
Excluded: BTK resistance mutation
Participants known to have mutations associated with resistance to BTK inhibitors from prior studies
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: BTK inhibitor (acalabrutinib) — current
Participants must be currently receiving acalabrutinib and have been taking acalabrutinib for between 3 and 7 months prior to initiating screening procedures
Cannot have received: allogeneic hematopoietic cell transplantation
Exception: allowed if >6 months prior
Allogeneic hematopoietic cell transplantation (HCT) within the last 6 months
Cannot have received: autologous hematopoietic cell transplantation
Exception: allowed if >3 months prior
Autologous HCT within the last 3 months
Cannot have received: BTK inhibitor
Exception: allowed if switched to acalabrutinib prior to lymphodepletion and total BTK inhibitor therapy ≤ 3-7 months
Prior failure of any BTK inhibitor therapy. (Participant WILL be allowed if, after administration of other BTK inhibitors they have switched to acalabrutinib prior to lymphodepletion, and if the duration of all BTK inhibitor therapy was ≤ 3-7 months).
Lab requirements
Blood counts
ANC ≥1000 cells/ul (exception: not required if bone marrow involvement); Platelet count ≥75,000/ul (exception: not required if bone marrow involvement)
Kidney function
Creatinine clearance of ≥ 50 mL/min per the Cockcroft-Gault formula
Liver function
Total serum bilirubin ≤ 2.0 mg/dL (Gilbert syndrome exception: total bilirubin ≥ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN); AST < 3 x ULN; ALT < 3 x ULN
Cardiac function
QTc ≤ 480 msec; Left ventricular ejection fraction >40%
Total serum bilirubin ≤ 2.0 mg/dL...AST < 3 x ULN...ALT < 3 x ULN...Creatinine clearance of ≥ 50 mL/min...ANC ≥1000 cells/ul...Platelet count ≥75,000/ul...QTc ≤ 480 msec; Left ventricular ejection fraction >40%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope Comprehensive Cancer Center · Duarte, California
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