B-Cell Non-Hodgkin LymphomaPhase 1NCT05432635
Genetically Modified T-cells (CMV-Specific CD19-CAR T-cells) Plus a Vaccine (CMV-MVA Triplex) Following Stem Cell Transplantation for the Treatment of Intermediate or High Grade B-cell Non-Hodgkin Lymphoma
A Phase 1 study testing Anti-CD19-CAR CMV-specific T-lymphocytes, Autologous Hematopoietic Stem Cell Transplantation and Multi-peptide CMV-Modified Vaccinia Ankara Vaccine in people with B-Cell Non-Hodgkin Lymphoma and Diffuse Large B-Cell Lymphoma, run by City of Hope Medical Center at 1 site in United States.
Trial summary
This phase I trial studies the safety and side effects of cytomegalovirus (CMV) specific CD19-chimeric antigen receptor (CAR) T-cells along with the CMV-modified vaccinia Ankara (MVA) triplex vaccine following a stem cell transplant in treating patients with high grade B-cell non-Hodgkin lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B-Cell Non-Hodgkin Lymphoma, Diffuse Large B-Cell Lymphoma, Mantle Cell Lymphoma
- What is being tested?
- Anti-CD19-CAR CMV-specific T-lymphocytes, Autologous Hematopoietic Stem Cell Transplantation and Multi-peptide CMV-Modified Vaccinia Ankara Vaccine
- Type of treatment
- Vaccines, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2023to 30 Dec 2028
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented informed consent of the participant and/or legally authorized representative.
- Assent, when appropriate, will be obtained per institutional guidelines
- Agreement 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 City of Hope (COH) certified interpreter/translator to proceed with screening and leukapheresis, while the request for a translated full consent is processed
- Age >= 18 years
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- Karnofsky performance status (KPS) >= 70
- Life expectancy >= 16 weeks at the time of enrollment
- Patients with an indication to be considered for HSCT, who are diagnosed with intermediate or high-grade B cell NHL (e.g., diffuse large B-cell lymphoma [DLBCL], mantle cell lymphoma [MCL], or transformed NHL) in first relapse after achieving complete remission (CR) or did not achieve CR after a first line therapy
- Note: COH pathology review should confirm that research participant's diagnostic material is consistent with history of intermediate or high-grade CD19+ malignancy
- No known contraindications to myeloablative HSCT, leukapheresis, steroids or tocilizumab, smallpox vaccine and any other modified vaccinia Ankara (MVA)-based vaccines
- Patient must be CMV seropositive
- Total serum bilirubin =< 2.0 mg/dL
- Participants with Gilbert syndrome may be included if their total bilirubin is =< 3.0
- Aspartate aminotransferase (AST) < 2.5 x upper limits of normal (ULN)
- Alanine aminotransferase (ALT) < 2.5 x ULN
- Serum creatinine =< 2.5 x ULN or estimated creatinine clearance of >= 40 mL/min per the Cockcroft-Gault formula, and the participant is not on hemodialysis
- Absolute neutrophil count >= 1000/uL (Transfusions and growth factors must not be used to meet this requirement at initial screening)
- Hemoglobin (Hb) >= 8 g/dl (Transfusions and growth factors must not be used to meet this requirement at initial screening)
- Platelet count >= 50,000/uL (>= 30,000/uL if bone marrow plasma cells are => 50 percent of cellularity) (Transfusions and growth factors must not be used to meet this requirement at initial screening)
- Left ventricular ejection fraction >= 45 percent within 8 weeks before enrollment
- Oxygen (O2) saturation > 92% without requiring supplemental oxygen
- Women of childbearing potential (WOCBP): negative urine or serum pregnancy test
- If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
- Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months after the last dose of protocol therapy.
- Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for > 1 year (women only)
Who cannot join
- Prior autologous/allogeneic stem cell transplant
- Growth factors within 14 days of enrollment
- Platelet transfusions within 7 days of enrollment
- Concurrent use of systemic steroids or chronic use of immunosuppressant medications. Recent or current use of inhaled or topical steroids in standard doses is not exclusionary. Physiologic replacement of steroids (prednisone =< 5 mg /day, or equivalent doses of other corticosteroids) is allowed
- Patients with active autoimmune disease requiring systemic immune suppressive therapy are not allowed
- Participants may not be receiving any other investigational agents or concurrent biological therapy, chemotherapy, or radiation therapy
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- Any standard contraindications to myeloablative HSCT per standard of care practices at COH
- Subjects with clinically significant arrhythmia or arrhythmias not stable on medical management within two weeks of screening
- Subjects with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system (CNS), including seizure disorder, any measurable masses of CNS, or any other active CNS disease. Note: Research participants with a history of CNS disease that has been effectively treated to complete remission (< 5 white blood cells [WBC] / mm^3 and no blasts in cerebrospinal fluid [CSF]) will be eligible
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents or cetuximab
- Known bleeding disorders (e.g., von Willebrand's disease) or hemophilia
- History of stroke or intracranial hemorrhage within 6 months prior to screening
- History of other malignancies, except for malignancy surgically resected (or treated with other modalities) with curative intent, basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; non-muscle invasive bladder cancer; malignancy treated with curative intent with no known active disease present for >= 3 years.
- Clinically significant uncontrolled illness
- Active infection requiring antibiotics
- Immunodeficiency virus (human immunodeficiency virus [HIV]) positive
- Active viral hepatitis
- Females only: Pregnant or breastfeeding
- 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
- Procedures (including compliance issues related to feasibility/logistics). Prospective participants who, in the opinion of the investigator, may not be able to comply with all study
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
City of Hope Medical Center
Duarte, California, 91010
Alex Herrera, 626-218-2405, aherrera@coh.org
Alex L. Herrera
About this study
Official title: Pilot/Feasibility Study of CMV-Specific CD19-CAR T Cells Plus CMV-MVA Triplex Following Autologous Hematopoietic Stem Cell Transplantation for Patients With Intermediate or High Grade B-Lineage Non-Hodgkin Lymphoma (B-NHL)
This phase I trial studies the safety and side effects of cytomegalovirus (CMV) specific CD19-chimeric antigen receptor (CAR) T-cells along with the CMV-modified vaccinia Ankara (MVA) triplex vaccine following a stem cell transplant in treating patients with high grade B-cell non-Hodgkin lymphoma. CAR T-cells are a type of treatment in which a patient's T-cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T-cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T-cells are grown in the laboratory and given to the patient by infusion. Vaccines such as CMV-MVA triplex are made from gene-modified viruses and may help the body build an effective immune response to kill cancer cells. Giving CMV-specific CD19-CAR T-cells plus the CMV-MVA triplex vaccine following a stem cell transplant may help prevent the cancer from coming back.
Read the detailed description
PRIMARY OBJECTIVE:
- Assess the safety and describe the toxicity profile of anti-CD19-CAR CMV-specific T-lymphocytes (CMV-specific CD19-CAR T cells) alone and when given in combination with multi-peptide CMV-modified vaccinia Ankara vaccine (CMV-modified vaccinia Ankara [MVA] triplex vaccine) following autologous hematopoietic cell transplantation (autoHSCT) to treat participants with intermediate or high grade B-lineage non-Hodgkin lymphoma (NHL) who are in first relapse after achieving complete remission (CR) or did not achieve CR after a first line therapy.
SECONDARY OBJECTIVES:
- Determine the feasibility of autologous CMV-specific CD19-CAR T cell manufacturing, as assessed by the ability to meet the required cell dose and product release requirements in 5 out of 6 enrolled participants.
II. Determine short- and longer-term CMV-specific CD19-CAR T cell in vivo expansion and persistence.
III. Assess whether the CMV-specific CD19-CAR T cells respond to CMV-MVA triplex vaccine.
IV. Estimate the rate of CMV reactivation after CAR T cell infusion. V. Estimate the rate of progression-free survival (PFS) and median overall survival (OS) at 12 months post-autoHSCT.
EXPLORATORY OBJECTIVES:
- Assess whether the CMV-specific CD19-CAR T cells respond to CMV-MVA triplex vaccine when administered to participants that received CAR T cells only in the safety lead-in portion in the expansion phase of the study (i.e., once safety of the CMV-MVA triplex vaccine is established in the feasibility portion of the study).
Ia. Participants who receive CMV-specific CD19-CAR T cells in the safety lead-in portion of the study may be eligible to receive the CMV-MVA Triplex vaccine in the expansion portion of the study per principal investigator (PI) discretion and if all other criteria to proceed with vaccine administration are met.
OUTLINE:
CONDITIONING REGIMEN: Patients receive standard conditioning regimen (typically carmustine, etoposide, cytarabine, melphalan) beginning approximately on day -9 in the absence of disease progression or unacceptable toxicity.
TRANSPLANTATION: Patients undergo autoHSCT on day -2.
CAR T-CELLS AND VACCINATION: Patients receive CMV-specific CD19-CAR T cells intravenously (IV) on day 0 and CMV-MVA triplex vaccine intramuscularly (IM) on days 28 and 56 in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 18-24 hours, weeks 1-3, at 1 month, at day 84, months 4-11, and at 1 year. Patients with disease progression or starting a prohibited therapy are also followed up on months 2-4, 6, and 12 after CAR T cell infusion, and then yearly for up to 15 years.
- Conditions
- B-Cell Non-Hodgkin Lymphoma, Diffuse Large B-Cell Lymphoma, Mantle Cell Lymphoma, Recurrent B-Cell Non-Hodgkin Lymphoma, Recurrent Diffuse Large B-Cell Lymphoma, Recurrent Mantle Cell Lymphoma
- Being tested
- Anti-CD19-CAR CMV-specific T-lymphocytes, Autologous Hematopoietic Stem Cell Transplantation, Multi-peptide CMV-Modified Vaccinia Ankara Vaccine, Myeloablative Conditioning
- Medical subject headings
- Lymphoma, B-Cell, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-CD19-CAR CMV-specific T-lymphocytesBiological
Also called CMV-specific CD19-CAR T Cells (SY); CMV-specific CD19 CAR-T Cells (SY); Anti-CD19-CAR CMV-specific T-cells (SY)
Given IV
Autologous Hematopoietic Stem Cell TransplantationProcedure or surgery
Undergo autoHSCT
Multi-peptide CMV-Modified Vaccinia Ankara VaccineBiological
Given IM
Myeloablative ConditioningProcedure or surgery
Given standard conditioning regimen
| Study group | Role | What they receive |
|---|---|---|
| Treatment (CMV-specific CD19-CAR T cells, triplex vaccine) | Experimental | CONDITIONING REGIMEN: Patients receive standard conditioning regimen (typically carmustine, etoposide, cytarabine, melphalan) beginning approximately on day -9 in the absence of disease progression or unacceptable toxicity.
TRANSPLANTATION: Patients undergo autoHSCT on day -2.
CAR T-CELLS AND VACCINATION: Patients receive CMV-specific CD19-CAR T cells IV on day 0 and CMV-MVA triplex vaccine IM on days 28 and 56 in the absence of disease progression or unacceptable toxicity. Receives: Biological: Anti-CD19-CAR CMV-specific T-lymphocytes; Procedure: Autologous Hematopoietic Stem Cell Transplantation; Biological: Multi-peptide CMV-Modified Vaccinia Ankara Vaccine; Procedure: Myeloablative Conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0 from data obtained at each clinical assessment. Will be summarized in terms of type (organ affected or laboratory determination), severity, time of onset, duration, probable association with the study treatment and reversibility or outcome.
Measured: Up to 15 years
Secondary outcomes (5)
Achievement of proposed 10×10^6 cytomegalovirus (CMV)-specific CD19-chimeric antigen receptor (CAR) T cells per product and meeting product release requirements for enrolled participants
Yield of at least 10×10^6 cytomegalovirus (CMV)-specific CD19-chimeric antigen receptor (CAR) T cells per product meeting product release requirements
Measured: Up to 56 days
Short- and long-term CMV-specific CD19-CAR T cell expansion and persistence
Will be assessed longitudinally. Persistence is defined as detection of >= 0.1% of CMV-specific CD19-CAR T cells in CD3+ cells in peripheral blood, 28 days after vaccine administration, by flow cytometry and Woodchuck Hepatitis Virus Posttranscriptional Regulatory Element (WPRE) quantitative polymerase chain reaction (Q-PCR). Expansion is defined as an increase of 2-fold in CMV-specific CD19-CAR T cells after Triplex administration compared with pre-vaccination cell number. Response to Triplex will be assessed based on numbers of EGFR+, pp65-specific IFNgamma+ and CD137+T cells.
Measured: Up to 15 years
Clinically significant CMV reactivation
Clinically significant defined as > 1250 IU/ml or 500 GC/mL) CMV reactivation requiring management treatment after CAR T cell infusion as assessed by PCR.
Measured: Up to 15 years
Progression-free survival (PFS)
Participants are considered a failure for this endpoint if they die (regardless of cause) or experience disease relapse.
Measured: From the start of treatment to the date of death, disease relapse, or last follow-up whichever occurs first, assessed up to 15 years
Overall survival (OS)
Participants are considered a failure for this endpoint if they die, regardless of cause. Will be estimated using the product-limit method of Kaplan and Meier.
Measured: From start of protocol therapy to death, or last follow-up, whichever comes first, assessed up to 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start1 Aug 2023
- Primary completion7 Mar 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-Cell Non-Hodgkin 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 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
- Alex Herrera, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05432635
- Sponsor's protocol ID
- 20695
- Other IDs
- NCI-2022-04622, 20695, P30CA033572, P50CA107399
- Status last verified
- Feb 2026
- First submitted
- 21 Jun 2022
- Last updated
- 23 Feb 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 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot/Feasibility Study of CMV-Specific CD19-CAR T Cells Plus CMV-MVA Triplex Following Autologous Hematopoietic Stem Cell Transplantation for Patients With Intermediate or High Grade B-Lineage Non-Hodgkin Lymphoma (B-NHL)
- ClinicalTrials.gov ID
- NCT05432635
- Acronym / sponsor ID
- 20695
- Conditions
- B-Cell Non-Hodgkin Lymphoma, Diffuse Large B-Cell Lymphoma, Mantle Cell Lymphoma, Recurrent B-Cell Non-Hodgkin Lymphoma, Recurrent Diffuse Large B-Cell Lymphoma, Recurrent Mantle Cell Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 7 Mar 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 27 Jun 2022 (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 I trial studies the safety and side effects of cytomegalovirus (CMV) specific CD19-chimeric antigen receptor (CAR) T-cells along with the CMV-modified vaccinia Ankara (MVA) triplex vaccine following a stem cell transplant in treating patients with high grade B-cell non-Hodgkin lymphoma. CAR T-cells are a type of treatment in which a patient's T-cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T-cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T-cells are grown in the laboratory and given to the patient by infusion. Vaccines such as CMV-MVA triplex are made from gene-modified viruses and may help the body build an effective immune response to kill cancer cells. Giving CMV-specific CD19-CAR T-cells plus the CMV-MVA triplex vaccine following a stem cell transplant may help prevent the cancer from coming back.
Detailed description
PRIMARY OBJECTIVE:
- Assess the safety and describe the toxicity profile of anti-CD19-CAR CMV-specific T-lymphocytes (CMV-specific CD19-CAR T cells) alone and when given in combination with multi-peptide CMV-modified vaccinia Ankara vaccine (CMV-modified vaccinia Ankara [MVA] triplex vaccine) following autologous hematopoietic cell transplantation (autoHSCT) to treat participants with intermediate or high grade B-lineage non-Hodgkin lymphoma (NHL) who are in first relapse after achieving complete remission (CR) or did not achieve CR after a first line therapy.
SECONDARY OBJECTIVES:
- Determine the feasibility of autologous CMV-specific CD19-CAR T cell manufacturing, as assessed by the ability to meet the required cell dose and product release requirements in 5 out of 6 enrolled participants.
II. Determine short- and longer-term CMV-specific CD19-CAR T cell in vivo expansion and persistence.
III. Assess whether the CMV-specific CD19-CAR T cells respond to CMV-MVA triplex vaccine.
IV. Estimate the rate of CMV reactivation after CAR T cell infusion. V. Estimate the rate of progression-free survival (PFS) and median overall survival (OS) at 12 months post-autoHSCT.
EXPLORATORY OBJECTIVES:
- Assess whether the CMV-specific CD19-CAR T cells respond to CMV-MVA triplex vaccine when administered to participants that received CAR T cells only in the safety lead-in portion in the expansion phase of the study (i.e., once safety of the CMV-MVA triplex vaccine is established in the feasibility portion of the study).
Ia. Participants who receive CMV-specific CD19-CAR T cells in the safety lead-in portion of the study may be eligible to receive the CMV-MVA Triplex vaccine in the expansion portion of the study per principal investigator (PI) discretion and if all other criteria to proceed with vaccine administration are met.
OUTLINE:
CONDITIONING REGIMEN: Patients receive standard conditioning regimen (typically carmustine, etoposide, cytarabine, melphalan) beginning approximately on day -9 in the absence of disease progression or unacceptable toxicity.
TRANSPLANTATION: Patients undergo autoHSCT on day -2.
CAR T-CELLS AND VACCINATION: Patients receive CMV-specific CD19-CAR T cells intravenously (IV) on day 0 and CMV-MVA triplex vaccine intramuscularly (IM) on days 28 and 56 in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 18-24 hours, weeks 1-3, at 1 month, at day 84, months 4-11, and at 1 year. Patients with disease progression or starting a prohibited therapy are also followed up on months 2-4, 6, and 12 after CAR T cell infusion, and then yearly for up to 15 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (CMV-specific CD19-CAR T cells, triplex vaccine) | Experimental | Biological: Anti-CD19-CAR CMV-specific T-lymphocytes, Procedure: Autologous Hematopoietic Stem Cell Transplantation, Biological: Multi-peptide CMV-Modified Vaccinia Ankara Vaccine, Procedure: Myeloablative ConditioningCONDITIONING REGIMEN: Patients receive standard conditioning regimen (typically carmustine, etoposide, cytarabine, melphalan) beginning approximately on day -9 in the absence of disease progression or unacceptable toxicity. TRANSPLANTATION: Patients undergo autoHSCT on day -2. CAR T-CELLS AND VACCINATION: Patients receive CMV-specific CD19-CAR T cells IV on day 0 and CMV-MVA triplex vaccine IM on days 28 and 56 in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Documented informed consent of the participant and/or legally authorized representative.
- Agreement to allow the use of archival tissue from diagnostic tumor biopsies.
- Note: For research participants who do not speak English, a short form consent may be used with a City of Hope (COH) certified interpreter/translator to proceed with screening and leukapheresis, while the request for a translated full consent is processed
- Age >= 18 years
- Karnofsky performance status (KPS) >= 70
Key exclusion criteria (21 listed)
- Prior autologous/allogeneic stem cell transplant
- Growth factors within 14 days of enrollment
- Platelet transfusions within 7 days of enrollment
- Concurrent use of systemic steroids or chronic use of immunosuppressant medications. Recent or current use of inhaled or topical steroids in standard doses is not exclusionary. Physiologic replacement of steroids (prednisone =< 5 mg /day, or equivalent doses of other corticosteroids) is allowed
- Patients with active autoimmune disease requiring systemic immune suppressive therapy are not allowed
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 |
|---|---|---|
| Anti-CD19-CAR CMV-specific T-lymphocytesAlso: CMV-specific CD19-CAR T Cells (SY); CMV-specific CD19 CAR-T Cells (SY); Anti-CD19-CAR CMV-specific T-cells (SY)Given IV | Biological | Treatment (CMV-specific CD19-CAR T cells, triplex vaccine) |
| Autologous Hematopoietic Stem Cell TransplantationUndergo autoHSCT | Procedure or surgery | Treatment (CMV-specific CD19-CAR T cells, triplex vaccine) |
| Multi-peptide CMV-Modified Vaccinia Ankara VaccineGiven IM | Biological | Treatment (CMV-specific CD19-CAR T cells, triplex vaccine) |
| Myeloablative ConditioningGiven standard conditioning regimen | Procedure or surgery | Treatment (CMV-specific CD19-CAR T cells, triplex vaccine) |
Primary outcome
Incidence of adverse events
Time frame: Up to 15 years
Will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0 from data obtained at each clinical assessment. Will be summarized in terms of type (organ affected or laboratory determination), severity, time of onset, duration, probable association with the study treatment and reversibility or outcome.
5 secondary outcomes
Achievement of proposed 10×10^6 cytomegalovirus (CMV)-specific CD19-chimeric antigen receptor (CAR) T cells per product and meeting product release requirements for enrolled participants
Time frame: Up to 56 days
Short- and long-term CMV-specific CD19-CAR T cell expansion and persistence
Time frame: Up to 15 years
Clinically significant CMV reactivation
Time frame: Up to 15 years
Progression-free survival (PFS)
Time frame: From the start of treatment to the date of death, disease relapse, or last follow-up whichever occurs first, assessed up to 15 years
Overall survival (OS)
Time frame: From start of protocol therapy to death, or last follow-up, whichever comes first, assessed up to 15 years
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 23 Feb 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.
Alex Herrera 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 1 study testing Anti-CD19-CAR CMV-specific T-lymphocytes, Autologous Hematopoietic Stem Cell Transplantation and Multi-peptide CMV-Modified Vaccinia Ankara Vaccine in people with B-Cell Non-Hodgkin Lymphoma and Diffuse Large B-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 26 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 23 Feb 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: Up to 15 years). 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 23 Feb 2026.