Recurrent Mantle Cell LymphomaPhase 2NCT04484012
Modified Immune Cells (CD19 CAR T Cells) and Acalabrutinib for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma
A Phase 2 study testing Acalabrutinib and CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem-enriched T-lymphocytes in people with Recurrent Mantle Cell Lymphoma and Refractory Mantle Cell Lymphoma, run by City of Hope Medical Center at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Recurrent Mantle Cell Lymphoma, Refractory Mantle Cell Lymphoma
- What is being tested?
- Acalabrutinib and CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem-enriched T-lymphocytes
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Dec 2020to 23 Feb 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Allogeneic hematopoietic cell transplantation (HCT) within the last 6 months.
- Autologous HCT within the last 3 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).
- Participants known to have mutations associated with resistance to BTK inhibitors from prior studies.
- Concomitant therapies
- 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.
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- 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.
- Requires treatment with a strong cytochrome P450 3A4 (CYP3A4) inhibitor/inducer.
- Unable to discontinue anticoagulation with warfarin or equivalent vitamin K antagonists (e.g., phenprocoumon) within 7 days of leukapheresis and remain off through end of study treatment.
- Other illnesses or conditions
- Class III/IV cardiovascular disability according to the New York Heart Association Classification. Subjects with controlled, asymptomatic atrial fibrillation can enroll.
- Participants with clinically significant arrhythmia or arrhythmias not stable on medical management.
- Active auto-immune disease requiring systemic immunosuppressive therapy, including uncontrolled autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenic purpura (ITP).
- Suspected or confirmed progressive multifocal leukoencephalopathy (PML).
- Requires major surgical procedure within 28 days prior to first dose of study drug. If a subject has major surgery, they must have recovered adequately from any toxicity and/or complications from the intervention before the first dose of study drug.
- Participants with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system.
- Known history of drug-specific hypersensitivity or anaphylaxis to either study agent.
- Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel that is likely to affect absorption, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass.
- Known bleeding disorders (e.g., von Willebrand's disease or hemophilia)
- History of stroke or intracranial hemorrhage within 6 months prior to enrollment.
- History of other malignancies, except for the following: malignancy surgically resected (or treated with other modalities) with curative intent, adequately treated in situ carcinoma of the breast or cervix uteri, basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; early stage prostate cancer on expectant management; malignancy treated with curative intent with no known active disease present for ≥ 3 years.
- Lactating women.
- Active chronic graft-versus-host disease (GVHD) post-allogeneic HCT.
- Uncontrolled active infection:
- HIV positive or have active hepatitis B or C infection based on testing performed within 4 weeks of enrollment.
- Hepatitis B or C serologic status: subjects who are hepatitis B core antibody (anti-HBc) positive and who are surface antigen negative will need to have a negative polymerase chain reaction (PCR) result. Those who are hepatitis B surface antigen (HbsAg) positive or hepatitis B PCR positive will be excluded.
- Subjects who are hepatitis B core antibody positive (or have a known history of HBV infection) should be monitored quarterly with a quantitative PCR test for HBV DNA. HBV monitoring should last until 12 months after last dose of study drug. Any subject with a rising viral load (above lower limit of detection) should discontinue study drug and have antiviral therapy instituted and a consultation with a physician with expertise in managing hepatitis B. Subjects who are core Ab positive at study enrollment are strongly recommended to start Entecavir before start and until completion of study treatment.
- Subjects who are hepatitis C antibody positive will need to have a negative PCR result. Those who are hepatitis C PCR positive will be excluded.
- Subjects who are positive cytomegalovirus [CMV] DNA polymerase chain reaction [PCR]).
- Subject with any active significant bacterial, fungal or viral (other than those listed) infections.
- Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns with clinical study procedures.
- Noncompliance
- Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics).
- Eligibility should be confirmed per institutional policies.
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
About this study
Official title: A Phase 2 Study to Evaluate CD19-Specific Chimeric Antigen Receptor (CAR)-T Cells Combined With Acalabrutinib for Patients With Relapsed or Refractory Mantle Cell Lymphoma (MCL)
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.
Read the detailed description
PRIMARY OBJECTIVES:
- Evaluate the safety of adding CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem-enriched T-lymphocytes (CD19 CAR T cells) to acalabrutinib treatment. (Safety Lead-in) II. Estimate the complete response (CR) rate within 6 months after adding CD19 CAR T cells to acalabrutinib treatment. (Phase 2)
SECONDARY OBJECTIVES:
- Assess best response, time to and duration of CR. II. Estimate the 1-year progression free survival (PFS) rate and overall survival (OS).
III. Describe the full toxicity profile.
EXPLORATORY OBJECTIVES:
- Assess CD19-CAR T cell persistence. II. Assess CD19-CAR T cell activity as measured by CD19 B cell aplasia. III. Describe the duration of CR from completion of acalabrutinib. IV. Describe immunogenicity of CD19-CAR T cells in the presence of the BTK inhibitor.
- Characterize CD19 expression on tumor cells. VI. Describe cytokine profile after CD19-CAR T cell infusion. VII. Determine BTK and PLCG2 mutational status prior to treatment.
OUTLINE:
Patients receive acalabrutinib orally (PO) twice daily (BID) on days -5 to 28 of cycle 1 and on days 1-28 of subsequent cycles. Patients also receive CD19 CAR T cells intravenously (IV) on day 0. Treatment with acalabrutinib repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients who have not attained CR after the first disease assessment and tolerated the initial CAR T cell infusion may receive a second CAR T cell infusion in cycle 2.
After completion of study treatment, patients are followed up at 3, 6 and 12 months, then yearly for up to 15 years post CAR T cells infusion.
- Being tested
- Acalabrutinib, CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem-enriched T-lymphocytes
- Medical subject headings
- Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcalabrutinibDrug
Also called ACP-196, Bruton Tyrosine Kinase Inhibitor ACP-196, Calquence
Given PO
CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem-enriched T-lymphocytesBiological
Also called CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem-enriched T Cells, CD19R(EQ)28zeta/EGFRt+ Naive and Memory T Cells, CD19R(EQ)28zetaEGFRt+ Tn/mem Cells
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Treatment (CD19 CAR T cells, acalabrutinib) | Experimental | Patients receive acalabrutinib PO BID on days -5 to 28 of cycle 1 and on days 1-28 of subsequent cycles. Patients also receive CD19 CAR T cells IV on day 0. Treatment with acalabrutinib repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients who have not attained CR after the first disease assessment and tolerated the initial CAR T cell infusion may receive a second CAR T cell infusion in cycle 2. Receives: Drug: Acalabrutinib; Biological: CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem-enriched T-lymphocytes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of dose-limiting toxicities (DLTs) (Safety Lead-in)
Rates and associated 95% Clopper and Pearson exact confidence interval (CI) will be estimated for DLTs at the safe dose.
Measured: Day 0 up to 28 days after the first chimeric antigen receptor (CAR) T cell infusion
Complete response (CR) (Phase II)
Response will be assessed based on Lugano classification. CR rate is defined as the proportion of response-evaluable participants who achieve a best response of CR within 6 months of CAR T-cell infusion and concurrent acalabrutinib therapy. Rates and associated 95% Clopper and Pearson exact CI will be estimated for CR within 6 months.
Measured: Within 6 months of CAR T-cell infusion and concurrent acalabrutinib therapy
Secondary outcomes (6)
Time to CR
Descriptive statistics will be used to summarize the time to CR among those who achieve CR.
Measured: From the first achievement of CR after CAR T cell infusion through disease relapse or progression or death, assessed up to 15 years
Duration of CR
Duration of CR will be assessed using Kaplan Meier methods.
Measured: From the first achievement of CR after CAR T cell infusion through disease relapse or progression or death, assessed up to 15 years
Best response
Defined as the best response documented at any time after CAR T cell infusion through 1 year after CAR T cell infusion or the start of any non-protocol anti-lymphoma therapy, whichever occurs first. Best response will be presented in tabular format including counts and percentages.
Measured: Up to 1 year post CAR T cell infusion
Progression-free survival (PFS)
Progression-free survival will be assessed using Kaplan Meier methods.
Measured: From start of protocol treatment (start of lymphodepletion) to the first observation of disease relapse/progression or death due to any cause, whichever occurs first, assessed at 1 year
Overall survival (OS)
OS will be assessed using Kaplan Meier methods.
Measured: From start of protocol treatment (start of lymphodepletion) to death due to any cause, assessed at 1 year
Incidence of adverse events
Toxicities will be recorded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5. Observed toxicities will be summarized by type, severity, date of onset (per each treatment cycle or follow-up period), and attribution.
Measured: Up to 15 year post CAR T cell infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start31 Dec 2020
- Primary completion23 Feb 2027 (estimated)
- Study completion23 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Mantle Cell LymphomaStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Lihua E Budde, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04484012
- Sponsor's protocol ID
- 19405
- Other IDs
- NCI-2020-04550, 19405, P30CA033572
- Status last verified
- Sep 2026
- First submitted
- 7 Jul 2020
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study to Evaluate CD19-Specific Chimeric Antigen Receptor (CAR)-T Cells Combined With Acalabrutinib for Patients With Relapsed or Refractory Mantle Cell Lymphoma (MCL)
- ClinicalTrials.gov ID
- NCT04484012
- Acronym / sponsor ID
- 19405
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 31 Dec 2020 (actual)
- Primary completion
- 23 Feb 2027 (estimated)
- Study completion
- 23 Feb 2027 (estimated)
- First posted
- 23 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- Evaluate the safety of adding CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem-enriched T-lymphocytes (CD19 CAR T cells) to acalabrutinib treatment. (Safety Lead-in) II. Estimate the complete response (CR) rate within 6 months after adding CD19 CAR T cells to acalabrutinib treatment. (Phase 2)
SECONDARY OBJECTIVES:
- Assess best response, time to and duration of CR. II. Estimate the 1-year progression free survival (PFS) rate and overall survival (OS).
III. Describe the full toxicity profile.
EXPLORATORY OBJECTIVES:
- Assess CD19-CAR T cell persistence. II. Assess CD19-CAR T cell activity as measured by CD19 B cell aplasia. III. Describe the duration of CR from completion of acalabrutinib. IV. Describe immunogenicity of CD19-CAR T cells in the presence of the BTK inhibitor.
- Characterize CD19 expression on tumor cells. VI. Describe cytokine profile after CD19-CAR T cell infusion. VII. Determine BTK and PLCG2 mutational status prior to treatment.
OUTLINE:
Patients receive acalabrutinib orally (PO) twice daily (BID) on days -5 to 28 of cycle 1 and on days 1-28 of subsequent cycles. Patients also receive CD19 CAR T cells intravenously (IV) on day 0. Treatment with acalabrutinib repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients who have not attained CR after the first disease assessment and tolerated the initial CAR T cell infusion may receive a second CAR T cell infusion in cycle 2.
After completion of study treatment, patients are followed up at 3, 6 and 12 months, then yearly for up to 15 years post CAR T cells infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (CD19 CAR T cells, acalabrutinib) | Experimental | Drug: Acalabrutinib, Biological: CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem-enriched T-lymphocytesPatients receive acalabrutinib PO BID on days -5 to 28 of cycle 1 and on days 1-28 of subsequent cycles. Patients also receive CD19 CAR T cells IV on day 0. Treatment with acalabrutinib repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients who have not attained CR after the first disease assessment and tolerated the initial CAR T cell infusion may receive a second CAR T cell infusion in cycle 2. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (34 listed)
- Allogeneic hematopoietic cell transplantation (HCT) within the last 6 months.
- Autologous HCT within the last 3 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).
- Participants known to have mutations associated with resistance to BTK inhibitors from prior studies.
- Concomitant therapies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcalabrutinibAlso: ACP-196, Bruton Tyrosine Kinase Inhibitor ACP-196, CalquenceGiven PO | Drug | Treatment (CD19 CAR T cells, acalabrutinib) |
| CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem-enriched T-lymphocytesAlso: CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem-enriched T Cells, CD19R(EQ)28zeta/EGFRt+ Naive and Memory T Cells, CD19R(EQ)28zetaEGFRt+ Tn/mem CellsGiven IV | Biological | Treatment (CD19 CAR T cells, acalabrutinib) |
Primary outcome
Occurrence of dose-limiting toxicities (DLTs) (Safety Lead-in)
Time frame: Day 0 up to 28 days after the first chimeric antigen receptor (CAR) T cell infusion
Rates and associated 95% Clopper and Pearson exact confidence interval (CI) will be estimated for DLTs at the safe dose.
Complete response (CR) (Phase II)
Time frame: Within 6 months of CAR T-cell infusion and concurrent acalabrutinib therapy
Response will be assessed based on Lugano classification. CR rate is defined as the proportion of response-evaluable participants who achieve a best response of CR within 6 months of CAR T-cell infusion and concurrent acalabrutinib therapy. Rates and associated 95% Clopper and Pearson exact CI will be estimated for CR within 6 months.
6 secondary outcomes
Time to CR
Time frame: From the first achievement of CR after CAR T cell infusion through disease relapse or progression or death, assessed up to 15 years
Duration of CR
Time frame: From the first achievement of CR after CAR T cell infusion through disease relapse or progression or death, assessed up to 15 years
Best response
Time frame: Up to 1 year post CAR T cell infusion
Progression-free survival (PFS)
Time frame: From start of protocol treatment (start of lymphodepletion) to the first observation of disease relapse/progression or death due to any cause, whichever occurs first, assessed at 1 year
Overall survival (OS)
Time frame: From start of protocol treatment (start of lymphodepletion) to death due to any cause, assessed at 1 year
Incidence of adverse events
Time frame: Up to 15 year post CAR T cell infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lihua E Budde principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Acalabrutinib and CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem-enriched T-lymphocytes in people with Recurrent Mantle Cell Lymphoma and Refractory Mantle Cell Lymphoma, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of dose-limiting toxicities (DLTs) (Safety Lead-in) (time frame: Day 0 up to 28 days after the first chimeric antigen receptor (CAR) T cell infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.