Modified Immune Cells (CD19 CAR T Cells) and Acalabrutinib for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma
Eligible age
18–75 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: City of Hope Medical Center
You may qualify if…
- ✓ 1. All participants must have the ability to understand and the willingness to sign a written informed consent.
- ✓ 2. Participants must agree to allow the use of archival tissue from diagnostic tumor biopsies.
- ✓ If unavailable, exceptions may be granted with Study PI approval. Note: For research participants who do not speak English, a short form consent may be used with a COH certified interpreter/translator to proceed with screening and leukapheresis, while the request for a translated full consent is processed.
- ✓ Age Criteria
- ✓ 3. Age 18 years and older. Performance Status
- ✓ 4. ECOG Performance status ≤ 2 or KPS ≥ 70% (Appendix A) Nature of Illness and Treatment-Related Criteria
- ✓ 5. Documented CD19+ MCL by flow cytometry or IHC (from biopsy) if prior CD19 directed therapy was previously used
- ✓ a. BM is optional at enrollment IF patient already has biopsy proven disease.
You may not qualify if…
- ✕ 1. Allogeneic hematopoietic cell transplantation (HCT) within the last 6 months.
- ✕ 2. Autologous HCT within the last 3 months.
- ✕ 3. 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).
- ✕ 4. Participants known to have mutations associated with resistance to BTK inhibitors from prior studies.
- ✕ Concomitant therapies
- ✕ 5. Concurrent use of systemic steroids or chronic use of immunosuppressant medications. Recent or current use of inhaled steroids is not exclusionary. Physiologic replacement of steroids (i.e., prednisone ≤ 7.5 mg /day, or hydrocortisone ≤ 20 mg /day) is allowed. During study participation, participants may receive systemic corticosteroids as needed for treatment-emergent comorbid conditions.
- ✕ 6. Approved anti-cancer therapies other than acalabrutinib are not allowed after enrollment, with the exception of steroids or involved field radiation to control progressive disease during cell manufacturing, prior to lymphodepletion/start of protocol therapy.
- ✕ 7. Requires treatment with a strong cytochrome P450 3A4 (CYP3A4) inhibitor/inducer.
Where it's recruiting
Duarte
Source: ClinicalTrials.gov · NCT04484012 · last updated 2025-11-26