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Modified Immune Cells (CD19 CAR T Cells) and Acalabrutinib for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma

StatusActive, Not Recruiting
PhasePhase 2
Started2020-12-31
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Sep 2, 2026 → Feb 23, 2027
See other at-risk trials from City of Hope Medical Center

Amendment history

2026-10-02
Enrollment closed, study ongoing
Primary completion pushed: 2026-09-02 → 2027-02-23
Completion pushed: 2026-09-02 → 2027-02-23
2025-11-24
Study Status v9
Primary completion date2025-09-02→2026-09-02
Completion date2025-09-02→2026-09-02
2024-12-18
Study Status v8
Primary completion date2024-12-02→2025-09-02
Completion date2024-12-02→2025-09-02
2024-10-21
Study Status v7
Primary completion date2024-09-02→2024-12-02
Completion date2024-09-02→2024-12-02
2024-06-21
Study Status, Eligibility v6
Eligibility criteria+1,149 characters
Inclusion Criteria: Informed Consent and Willingness to Participate All participants must have the ability to understand and the willingness to sign a written informed consent. Participants must agree to allow the use of archival tissue from diagnostic tumor biopsies. If unavailable, exceptions may be granted with studyStudy principal investigator (PI) approval. EasternNote: CooperativeFor Oncologyresearch Groupparticipants (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 [...] [...]
Show 5 earlier versions
2023-06-19
Study Status v5
Primary completion date2023-12-31→2024-09-02
Completion date2023-12-31→2024-09-02
2022-06-16
Study Status v4
Re-verified, no change to tracked fields
2021-06-15
Study Identification, Study Status, Oversight, Outcome Measures, Eligibility, Contacts/Locations v3
Primary completion date2023-09-04→2023-12-31
Completion date2023-09-04→2023-12-31
Eligibility criteria+12 characters
[...] by flow cytometry or immunohistochemistry (IHC) (from biopsy) conductedif withinprior 3CD19 monthsdirected oftherapy screening)was previously used Participants must be currently receiving acalabrutinib and [...]
Secondary endpointsdetails revised at 1 of 6 entries
Study sitescontacts updated at 1 of 1 site
2021-02-09
Study Status v2
Start dateestimated 2021-01-15→confirmed 2020-12-31
2020-12-15
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start date2020-09-04→2021-01-15
Study sitesdetails revised at 1 of 1 site
2020-07-21
Original filing
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.
Trial Details
NCT Number NCT04484012
Lead Sponsor City of Hope Medical Center
Collaborators: National Cancer Institute (NCI)
Conditions Recurrent Mantle Cell Lymphoma, Refractory Mantle Cell Lymphoma
Enrollment 36 participants
Start Date 2020-12-31
Primary Completion 2027-02-23 (estimated)
Study Completion 2027-02-23 (estimated)
Updated on ClinicalTrials.gov 2026-10-01