Acute Lymphoblastic Leukemia (ALL)Phase 1MULTIPRATNCT00840853
Multi-virus CTLs Expressing CD19 Chimeric Receptors, CD19 Positive Malignancies Post SCT, MULTIPRAT
A Phase 1 study testing CD19CAR/virus specific T cells and Benadryl and Tylenol in people with Acute Lymphoblastic Leukemia (ALL) and Chronic Lymphocytic Leukemia (CLL), run by Baylor College of Medicine at 2 sites in United States.
Trial summary
Subjects are having a bone marrow or SCT for either a type of cancer of the blood called Leukemia or a cancer of the lymph nodes called non- Hodgkin's Lymphoma. Although a transplant can cure leukemia or lymphoma, some people will relapse. In those who relapse, current treatment cures only a very small percentage. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Lymphoblastic Leukemia (ALL), Chronic Lymphocytic Leukemia (CLL), Non Hodgkin's Lymphoma
- What is being tested?
- CD19CAR/virus specific T cells and Benadryl and Tylenol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2009to Apr 2031
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Any patient regardless of sex or age with CD19+ B-ALL undergoing allogeneic HSCT (Group A)
- OR Any patient regardless of sex or age with CD19+ B-CLL or NHL undergoing allogeneic HSCT (Group B).
- AND
- With minimal residual disease (MRD) or relapse post-HSCT (for the phase I dose escalation)
- OR
- With no evidence of ALL or CLL/NHL post-HSCT (to be included in the expansion cohort
Show all 16Show fewer
- Patients with life expectancy greater than or equal to 6 weeks
- Patients with a Karnofsky/Lansky score greater than or equal to 50
- Donor HIV negative
- Patient or parent/guardian capable of providing informed consent
- Patients with bilirubin 2x normal or less, AST 3x normal or less, creatinine less than or equal to 2x normal for age and Hgb greater than 8.0
- Pulse oximetry of greater than 90% on room air
- Sexually active patients must be willing to utilize one of the more effective birth control methods for 6 months after the CTL infusion. The male partner should use a condom.
- Available allogeneic CD19CAR transduced tri-virus-specific cytotoxic T lymphocytes with greater than or equal to15% expression of CD19CAR determined by flow-cytometry and greater than 10% killing of one or more viral antigen pulsed targets in a cytotoxicity assay at an effector:target ratio of 20:1.*
- Patients should have been off other investigational antiviral or antitumor therapy for one month prior to entry in this study.
- Note: Cell dose is based on total cell numbers and not individual antivirus or antileukemic cell numbers.
Who cannot join
- Severe intercurrent infection
- Evidence of graft versus host disease >grade II
- Pregnant or lactating
- History of hypersensitivity reactions to murine protein-containing products.
- Currently taking corticosteroids for therapy of GVHD.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Houston Methodist Hospital
Houston, Texas, 77030
Texas Children's Hospital
Houston, Texas, 77030
About this study
Official title: Phase I Study of the Administration of Multi-Virus-Specific Cytotoxic T Lymphocytes Expressing CD19 Chimeric Receptors for Prophylaxis or Therapy of Relapse of CD19 Positive Malignancies Post Hematopoietic Stem Cell Transplantation
Subjects are having a bone marrow or SCT for either a type of cancer of the blood called Leukemia or a cancer of the lymph nodes called non- Hodgkin's Lymphoma. Although a transplant can cure leukemia or lymphoma, some people will relapse. In those who relapse, current treatment cures only a very small percentage. Although giving patients a dose of donor immune cells before relapse can prevent relapse of the leukemia or lymphoma, DLI can also cause a serious complication called graft versus host disease (GVHD). This is a gene transfer research study using special immune cells which are specific for these cancer cells.
The body has different ways of fighting infection and disease. This study combines 2 of those ways, antibodies and T cells. T cells (CTLs or cytotoxic T cells) are infection-fighting blood cells that can kill cells, including tumor cells. Antibodies and T cells have been used to treat patients with cancers; they have shown promise, but haven't been strong enough to cure most patients.
Read more
The antibody used in this study is called anti-CD19. This antibody sticks to leukemia cells because of a substance on the outside of these cells called CD19. For this study, the anti-CD19 antibody has been changed so that instead of floating free in the blood it is now joined to T cells. When an antibody is joined to a T cell in this way it's called a chimeric receptor.
In the laboratory, investigators found that T cells that are trained to recognize common viruses can stay in the blood stream for many years. By joining the anti-CD19 antibody to CTLs that recognize viruses, they believe that they will also be able to make a cell that can last a long time in the body, provide protection from viruses, and recognize and kill leukemia. The CTLs which we will join the anti-CD19 antibody to attack 3 viruses (trivirus-specific CTLs), CMV, EBV, and adenovirus.
Studies have shown that trivirus-specific CTLs grown from the stem cell donor can be given safely to transplant recipients and can stop these viruses from causing severe infections. These CD19 chimeric receptor trivirus specific T cells are an investigational product not approved by the FDA.
The purpose of this study is to find the biggest dose of chimeric T cells that is safe, to assess the side effects, to see how long the T cells last and to evaluate whether this therapy might help prevent infections and relapse in people with CD19+ leukemia or lymphoma having a SCT.
Read the detailed description
The donor gave us blood to make CD19 chimeric receptor trivirus specific T cells in the laboratory. These cells were grown and frozen for the subject. To make these special T cells they are grown with stimulator cells. Stimulator cells are also made from the donor's blood but they are irradiated so that they can no longer grow. Stimulator cells have been infected with viruses so that they carry proteins from 3 viruses (CMV, adenovirus, and EBV). These cells are cultured with the T cells so that they can learn to see and attack cells infected with CMV, EBV and adenovirus.
To get the CD19 antibody to attach to the surface of the T cell, an antibody gene was inserted into the T cell. This is done with a virus called a retrovirus that has been made for this study and will carry the antibody gene into the T cell. This virus also helps to find the T cells in the blood after injected. Once sufficient numbers of T cells are made, the investigators freeze the cells and test them to make sure they kill CD19+ tumors cells and cells infected with CMV, EBV and adenovirus. Once testing is completed the cells will be ready to give to the subject.
When the subject enrolls on this study, they will be assigned a dose of CD19 chimeric receptor trivirus specific T cells. The subject will be given an injection of cells into the vein through an IV line at the assigned dose. The injection will take about 20 minutes. Investigators will monitor the subject in the clinic after the injection for up to 3 hours. The treatment will be given by the Center for Cell and Gene Therapy at Texas Children's Hospital or The Methodist Hospital.
To learn more about the way the CD19 chimeric receptor trivirus specific T cells are working and how long they last in the body, extra blood will be drawn. The total blood drawn during this study will not exceed 300 tsp.
For subjects receiving the CTLs for treatment of their disease: If the subject has stable disease (the tumor did not grow) or there is a reduction in the size of the tumor on imaging studies or by blood count after the T-cell infusion, the subject can receive up to six additional doses of the T cells if they wish. After each T-cell infusion, the subject will be monitored.
Because the subject will have received cells with a new gene in them the subject will be followed for a total of 15 years to see if there are any long term side effects of gene transfer.
- Conditions
- Acute Lymphoblastic Leukemia (ALL), Chronic Lymphocytic Leukemia (CLL), Non Hodgkin's Lymphoma
- Being tested
- CD19CAR/virus specific T cells, Benadryl and Tylenol
- Keywords
- Stem cell transplant, Acute Lymphoblastic Leukemia (ALL), Chronic Lymphocytic Leukemia (CLL), Non Hodgkin's Lymphoma, Cytotoxic T lymphocytes, CTL, CD-19, chimeric receptor
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD19CAR/virus specific T cellsGenetic
CD19CAR/virus specific T cells will be thawed and given by intravenous injection from day +30 post transplant.
Benadryl and TylenolDrug
Also called Diphenhydramine and acetaminophen
Patients may be premedicated with Benadryl and Tylenol before receiving the injection of cells.
| Study group | Role | What they receive |
|---|---|---|
| Group A with disease | Experimental | CD19+ B-ALL undergoing allogeneic HSCT, with minimal residual disease or relapse post-HSCT
Patients will receive one of the following dose levels of CD19CAR/virus specific T cells:
Dose Level 1: 1.5 x 10^7/m2
Dose Level 2: 4.5 x 10^7/m2
Dose Level 3: 1.2 x 10^8/m2
Patients will be evaluated in the clinic and a single dose of CTL will be administered from day +30 post-HSCT.
Patients may be premedicated with Benadryl and Tylenol before receiving the injection of cells.
If patients with relapse have a partial response or have stable disease they will be eligible to receive up to 6 further doses of CTLs, each of which will consist of the same number or less than as their first injection. Receives: Genetic: CD19CAR/virus specific T cells; Drug: Benadryl and Tylenol |
| Group A without disease | Experimental | CD19+ B-ALL undergoing allogeneic HSCT, without detectable disease post-HSCT.
Patients will receive CD19CAR/virus specific T cells - Dose Level 1: 1.5 x 10^7/m2
Patients will be evaluated in the clinic and a single dose of CTL will be administered from day +30 post-HSCT.
Patients may be premedicated with Benadryl and Tylenol before receiving the injection of cells. Receives: Genetic: CD19CAR/virus specific T cells; Drug: Benadryl and Tylenol |
| Group B with disease | Experimental | CD19+ B cell CLL or NHL undergoing allogeneic HSCT, with minimal residual disease or relapse post-HSCT
Patients will receive one of the following dose levels of CD19CAR/virus specific T cells:
Dose Level 1: 1.5 x 10^7/m2
Dose Level 2: 4.5 x 10^7/m2
Dose Level 3: 1.2 x 10^8/m2
Patients will be evaluated in the clinic and a single dose of CTL will be administered from day +30 post-HSCT.
Patients may be premedicated with Benadryl and Tylenol before receiving the injection of cells.
If patients with relapse have a partial response or have stable disease they will be eligible to receive up to 6 further doses of CTLs, each of which will consist of the same number or less than as their first injection. Receives: Genetic: CD19CAR/virus specific T cells; Drug: Benadryl and Tylenol |
| Group B without disease | Experimental | CD19+ B cell CLL or NHL undergoing allogeneic HSCT, without detectable disease post-HSCT
Patients will receive CD19CAR/virus specific T cells -
Dose Level 1: 1.5 x 10^7/m2
Patients will be evaluated in the clinic and a single dose of CTL will be administered from day +30 post-HSCT.
Patients may be premedicated with Benadryl and Tylenol before receiving the injection of cells. Receives: Genetic: CD19CAR/virus specific T cells; Drug: Benadryl and Tylenol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of dose limiting toxicities
Dose limiting toxicity (DLT) is defined as development of grade III-IV GVHD or NCI CTC grade 3-5 toxicity that is not preexisting and/or not due to the underlying malignancy or infection or treatment of relapse within 30 days of study drug administration. DLTs will be graded according to NCI CTCAE v3.0.
Measured: 6 weeks
Secondary outcomes (3)
Tumor response to gene modified CTL on measurable disease.
When appropriate, serial measurements of tumor burden will be performed either using absolute tumor cell numbers in marrow and peripheral blood or percentage of cells positive for specific cytogenetic abnormalities and/or levels of minimal residual disease by flow cytometry and molecular methods. These measures of disease activity before and after CTL infusion will be analyzed descriptively. In patients with detectable tumors and/or lymphadenopathy - response and progression will be evaluated in this study using the international criteria proposed by RECIST.
Measured: up to 15 years
Frequency of T-cells expressing gene-modified CTLs.
To evaluate the impact of the gene modified CTL on virus-specific T-lymphocyte immune reconstitution. The repeat measurements on proliferation, immune function, etc. on each patient. Descriptive statistics using mean ± SD, medians and ranges will be calculated to summarize repeated measurements of CTL expansion, persistence, and function following infusion. Immune response to viral and leukemic antigens measured by ELISPOT will be analyzed. Plots of growth curves will be generated to graphically illustrate patterns of survival and expansion of T cells as well as immune response.
Measured: up to 15 years
Frequency of CD19+ B-Cells post HSCT expressing gene-modified CTLs
To evaluate the impact of the gene modified CTL on normal CD19+ B-cell immune reconstitution post-HSCT. The repeat measurements on proliferation, immune function, etc. on each patient will be analyzed. Descriptive statistics using mean ± SD, medians and ranges will be calculated to summarize repeated measurements of CTL expansion, persistence, and function following infusion. Immune response to viral and leukemic antigens measured by ELISPOT will be analyzed. Plots of growth curves will be generated to graphically illustrate patterns of survival and expansion of T cells as well as immune response.
Measured: 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 posted10 Feb 2009 (estimated)
- Study startApr 2009
- Primary completionApr 2016
- Study completionApr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Lymphoblastic Leukemia (ALL)Studies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The Methodist Hospital Research Institute, Center for Cell and Gene Therapy, Baylor College of Medicine
- Responsible party
- Principal investigator, Helen Heslop, Baylor College of Medicine
- Investigators
- Helen E Heslop, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00840853
- Sponsor's protocol ID
- 23637-MULTIPRAT
- Other IDs
- MultiPRAT
- Acronym
- MULTIPRAT
- Status last verified
- Sep 2026
- First submitted
- 9 Feb 2009
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Sun J, Huye LE, Lapteva N, Mamonkin M, Hiregange M, Ballard B, Dakhova O, Raghavan D, Durett AG, Perna SK, Omer B, Rollins LA, Leen AM, Vera JF, Dotti G, Gee AP, Brenner MK, Myers DG, Rooney CM. Early transduction produces highly functional chimeric antigen receptor-modified virus-specific T-cells with central memory markers: a Production Assistant for Cell Therapy (PACT) translational application. J Immunother Cancer. 2015 Feb 18;3:5. doi: 10.1186/s40425-015-0049-1. eCollection 2015.
PubMed 25734008Cruz CR, Micklethwaite KP, Savoldo B, Ramos CA, Lam S, Ku S, Diouf O, Liu E, Barrett AJ, Ito S, Shpall EJ, Krance RA, Kamble RT, Carrum G, Hosing CM, Gee AP, Mei Z, Grilley BJ, Heslop HE, Rooney CM, Brenner MK, Bollard CM, Dotti G. Infusion of donor-derived CD19-redirected virus-specific T cells for B-cell malignancies relapsed after allogeneic stem cell transplant: a phase 1 study. Blood. 2013 Oct 24;122(17):2965-73. doi: 10.1182/blood-2013-06-506741. Epub 2013 Sep 12.
PubMed 24030379
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of the Administration of Multi-Virus-Specific Cytotoxic T Lymphocytes Expressing CD19 Chimeric Receptors for Prophylaxis or Therapy of Relapse of CD19 Positive Malignancies Post Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT00840853
- Acronym / sponsor ID
- MULTIPRAT / 23637-MULTIPRAT
- Conditions
- Acute Lymphoblastic Leukemia (ALL), Chronic Lymphocytic Leukemia (CLL), Non Hodgkin's Lymphoma
- Keywords
- Stem cell transplant, Acute Lymphoblastic Leukemia (ALL), Chronic Lymphocytic Leukemia (CLL), Non Hodgkin's Lymphoma, Cytotoxic T lymphocytes, CTL, CD-19, chimeric receptor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- The Methodist Hospital Research Institute, Center for Cell and Gene Therapy, Baylor College of Medicine
- Study start
- Apr 2009
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2031 (estimated)
- First posted
- 10 Feb 2009 (estimated)
- 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.
Subjects are having a bone marrow or SCT for either a type of cancer of the blood called Leukemia or a cancer of the lymph nodes called non- Hodgkin's Lymphoma. Although a transplant can cure leukemia or lymphoma, some people will relapse. In those who relapse, current treatment cures only a very small percentage. Although giving patients a dose of donor immune cells before relapse can prevent relapse of the leukemia or lymphoma, DLI can also cause a serious complication called graft versus host disease (GVHD). This is a gene transfer research study using special immune cells which are specific for these cancer cells.
The body has different ways of fighting infection and disease. This study combines 2 of those ways, antibodies and T cells. T cells (CTLs or cytotoxic T cells) are infection-fighting blood cells that can kill cells, including tumor cells. Antibodies and T cells have been used to treat patients with cancers; they have shown promise, but haven't been strong enough to cure most patients.
The antibody used in this study is called anti-CD19. This antibody sticks to leukemia cells because of a substance on the outside of these cells called CD19. For this study, the anti-CD19 antibody has been changed so that instead of floating free in the blood it is now joined to T cells. When an antibody is joined to a T cell in this way it's called a chimeric receptor.
In the laboratory, investigators found that T cells that are trained to recognize common viruses can stay in the blood stream for many years. By joining the anti-CD19 antibody to CTLs that recognize viruses, they believe that they will also be able to make a cell that can last a long time in the body, provide protection from viruses, and recognize and kill leukemia. The CTLs which we will join the anti-CD19 antibody to attack 3 viruses (trivirus-specific CTLs), CMV, EBV, and adenovirus.
Studies have shown that trivirus-specific CTLs grown from the stem cell donor can be given safely to transplant recipients and can stop these viruses from causing severe infections. These CD19 chimeric receptor trivirus specific T cells are an investigational product not approved by the FDA.
The purpose of this study is to find the biggest dose of chimeric T cells that is safe, to assess the side effects, to see how long the T cells last and to evaluate whether this therapy might help prevent infections and relapse in people with CD19+ leukemia or lymphoma having a SCT.
Detailed description
The donor gave us blood to make CD19 chimeric receptor trivirus specific T cells in the laboratory. These cells were grown and frozen for the subject. To make these special T cells they are grown with stimulator cells. Stimulator cells are also made from the donor's blood but they are irradiated so that they can no longer grow. Stimulator cells have been infected with viruses so that they carry proteins from 3 viruses (CMV, adenovirus, and EBV). These cells are cultured with the T cells so that they can learn to see and attack cells infected with CMV, EBV and adenovirus.
To get the CD19 antibody to attach to the surface of the T cell, an antibody gene was inserted into the T cell. This is done with a virus called a retrovirus that has been made for this study and will carry the antibody gene into the T cell. This virus also helps to find the T cells in the blood after injected. Once sufficient numbers of T cells are made, the investigators freeze the cells and test them to make sure they kill CD19+ tumors cells and cells infected with CMV, EBV and adenovirus. Once testing is completed the cells will be ready to give to the subject.
When the subject enrolls on this study, they will be assigned a dose of CD19 chimeric receptor trivirus specific T cells. The subject will be given an injection of cells into the vein through an IV line at the assigned dose. The injection will take about 20 minutes. Investigators will monitor the subject in the clinic after the injection for up to 3 hours. The treatment will be given by the Center for Cell and Gene Therapy at Texas Children's Hospital or The Methodist Hospital.
To learn more about the way the CD19 chimeric receptor trivirus specific T cells are working and how long they last in the body, extra blood will be drawn. The total blood drawn during this study will not exceed 300 tsp.
For subjects receiving the CTLs for treatment of their disease: If the subject has stable disease (the tumor did not grow) or there is a reduction in the size of the tumor on imaging studies or by blood count after the T-cell infusion, the subject can receive up to six additional doses of the T cells if they wish. After each T-cell infusion, the subject will be monitored.
Because the subject will have received cells with a new gene in them the subject will be followed for a total of 15 years to see if there are any long term side effects of gene transfer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A with disease | Experimental | Genetic: CD19CAR/virus specific T cells, Drug: Benadryl and TylenolCD19+ B-ALL undergoing allogeneic HSCT, with minimal residual disease or relapse post-HSCT Patients will receive one of the following dose levels of CD19CAR/virus specific T cells: Dose Level 1: 1.5 x 10^7/m2 Dose Level 2: 4.5 x 10^7/m2 Dose Level 3: 1.2 x 10^8/m2 Patients will be evaluated in the clinic and a single dose of CTL will be administered from day +30 post-HSCT. Patients may be premedicated with Benadryl and Tylenol before receiving the injection of cells. If patients with relapse have a partial response or have stable disease they will be eligible to receive up to 6 further doses of CTLs, each of which will consist of the same number or less than as their first injection. |
| Group A without disease | Experimental | Genetic: CD19CAR/virus specific T cells, Drug: Benadryl and TylenolCD19+ B-ALL undergoing allogeneic HSCT, without detectable disease post-HSCT. Patients will receive CD19CAR/virus specific T cells - Dose Level 1: 1.5 x 10^7/m2 Patients will be evaluated in the clinic and a single dose of CTL will be administered from day +30 post-HSCT. Patients may be premedicated with Benadryl and Tylenol before receiving the injection of cells. |
| Group B with disease | Experimental | Genetic: CD19CAR/virus specific T cells, Drug: Benadryl and TylenolCD19+ B cell CLL or NHL undergoing allogeneic HSCT, with minimal residual disease or relapse post-HSCT Patients will receive one of the following dose levels of CD19CAR/virus specific T cells: Dose Level 1: 1.5 x 10^7/m2 Dose Level 2: 4.5 x 10^7/m2 Dose Level 3: 1.2 x 10^8/m2 Patients will be evaluated in the clinic and a single dose of CTL will be administered from day +30 post-HSCT. Patients may be premedicated with Benadryl and Tylenol before receiving the injection of cells. If patients with relapse have a partial response or have stable disease they will be eligible to receive up to 6 further doses of CTLs, each of which will consist of the same number or less than as their first injection. |
| Group B without disease | Experimental | Genetic: CD19CAR/virus specific T cells, Drug: Benadryl and TylenolCD19+ B cell CLL or NHL undergoing allogeneic HSCT, without detectable disease post-HSCT Patients will receive CD19CAR/virus specific T cells - Dose Level 1: 1.5 x 10^7/m2 Patients will be evaluated in the clinic and a single dose of CTL will be administered from day +30 post-HSCT. Patients may be premedicated with Benadryl and Tylenol before receiving the injection of cells. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- Any patient regardless of sex or age with CD19+ B-ALL undergoing allogeneic HSCT (Group A)
- OR Any patient regardless of sex or age with CD19+ B-CLL or NHL undergoing allogeneic HSCT (Group B).
- AND
- With minimal residual disease (MRD) or relapse post-HSCT (for the phase I dose escalation)
- OR
Key exclusion criteria (5 listed)
- Severe intercurrent infection
- Evidence of graft versus host disease >grade II
- Pregnant or lactating
- History of hypersensitivity reactions to murine protein-containing products.
- Currently taking corticosteroids for therapy of GVHD.
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 |
|---|---|---|
| CD19CAR/virus specific T cellsCD19CAR/virus specific T cells will be thawed and given by intravenous injection from day +30 post transplant. | Genetic | Group A with disease, Group A without disease, Group B with disease, Group B without disease |
| Benadryl and TylenolAlso: Diphenhydramine and acetaminophenPatients may be premedicated with Benadryl and Tylenol before receiving the injection of cells. | Drug | Group A with disease, Group A without disease, Group B with disease, Group B without disease |
Primary outcome
Number of dose limiting toxicities
Time frame: 6 weeks
Dose limiting toxicity (DLT) is defined as development of grade III-IV GVHD or NCI CTC grade 3-5 toxicity that is not preexisting and/or not due to the underlying malignancy or infection or treatment of relapse within 30 days of study drug administration. DLTs will be graded according to NCI CTCAE v3.0.
3 secondary outcomes
Tumor response to gene modified CTL on measurable disease.
Time frame: up to 15 years
Frequency of T-cells expressing gene-modified CTLs.
Time frame: up to 15 years
Frequency of CD19+ B-Cells post HSCT expressing gene-modified CTLs
Time frame: 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 2 Oct 2026.
- Derived from this study: PubMed 25734008Sun J, Huye LE, Lapteva N, Mamonkin M, Hiregange M, Ballard B, Dakhova O, Raghavan D, Durett AG, Perna SK, Omer B, Rollins LA, Leen AM, Vera JF, Dotti G, Gee AP, Brenner MK, Myers DG, Rooney CM. Early transduction produces highly functional chimeric antigen receptor-modified virus-specific T-cells with central memory markers: a Production Assistant for Cell Therapy (PACT) translational application. J Immunother Cancer. 2015 Feb 18;3:5. doi: 10.1186/s40425-015-0049-1. eCollection 2015.
- Derived from this study: PubMed 24030379Cruz CR, Micklethwaite KP, Savoldo B, Ramos CA, Lam S, Ku S, Diouf O, Liu E, Barrett AJ, Ito S, Shpall EJ, Krance RA, Kamble RT, Carrum G, Hosing CM, Gee AP, Mei Z, Grilley BJ, Heslop HE, Rooney CM, Brenner MK, Bollard CM, Dotti G. Infusion of donor-derived CD19-redirected virus-specific T cells for B-cell malignancies relapsed after allogeneic stem cell transplant: a phase 1 study. Blood. 2013 Oct 24;122(17):2965-73. doi: 10.1182/blood-2013-06-506741. Epub 2013 Sep 12.
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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.
Helen E Heslop, MD principal investigator
Baylor College of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CD19CAR/virus specific T cells and Benadryl and Tylenol in people with Acute Lymphoblastic Leukemia (ALL) and Chronic Lymphocytic Leukemia (CLL), run by Baylor College of Medicine at 2 sites 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 16 inclusion and 5 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 2 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 2 sites 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?
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?
Number of dose limiting toxicities (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00840853, which also lists 2 linked publications.
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 2 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.