Non-Hodgkin LymphomaPhase 1ATECRABNCT00709033
T-cells or EBV Specific CTLs, Advanced B-Cell NHL and CLL
A Phase 1 study testing autologous or syngeneic PBTLs and EBV-CTLs in people with Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia, run by Baylor College of Medicine at 2 sites in United States.
Trial summary
Patients on this study have a type of lymph gland cancer called non-Hodgkin Lymphoma or chronic Lymphocytic Leukemia. Their lymphoma or CLL has come back or has not gone away after treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia
- What is being tested?
- autologous or syngeneic PBTLs and EBV-CTLs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2009to May 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- FOR TREATMENT:
- Recurrent low or intermediate grade B-cell lymphoma or B-CLL, or newly diagnosed patients unable to receive or complete standard therapy OR diagnosis of relapsed/refractory intermediate B cell lymphoma with a treatment plan that will include high dose therapy and autologous stem cell transplantation.
- CD19-positive tumor
- EBV seropositivity (in patient and donor, as applicable)
- Recovered from the acute toxic effects of all prior chemotherapy at least a week before entering this study.
- Not be currently receiving any investigational agents or have not received any tumor vaccines within the previous six weeks.
Show all 17Show fewer
- No treatment with rituximab within the previous 8 weeks.
- ANC > 500, Hgb > 8.0*
- Bilirubin less than 3 times the upper limit of normal*
- AST less than 5 times the upper limit of normal*
- Serum creatinine less than 3 times upper limit of normal*
- Pulse oximetry of > 90% on room air*
- Adequate pulmonary function with FEV1, FVC and DLCO >35%* of expected corrected for hemoglobin
- Karnofsky or Lansky score of > 60%.
- Available autologous or syngeneic transduced EBV-specific cytotoxic T lymphocytes and peripheral blood T-cells with 15% or greater expression of CD19CAR determined by flow-cytometry.
- Patients or legal guardians must understand and sign an informed consent indicating that they are aware this is a research study and have been told of its possible benefits and toxic side effects. Patients or their guardians will be given a copy of the consent form.
- Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 3 months after the study is concluded. The male partner should use a condom.
Who cannot join
- History of hypersensitivity reactions to murine protein-containing products.
- Pregnant or lactating.
- Tumor in a location where enlargement could cause airway obstruction.
- Active infection with HIV, HBV, HCV or CMV.
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 Peripheral Activated T-Cells and EBV Specific CTLs Expressing CD19 Chimeric Receptors For Advanced B-Cell Non-Hodgkin's Lymphoma And Chronic Lymphocytic Leukemia (ATECRAB)
Patients on this study have a type of lymph gland cancer called non-Hodgkin Lymphoma or chronic Lymphocytic Leukemia. Their lymphoma or CLL has come back or has not gone away after treatment. Because there is no standard treatment for the cancer at this time or because the currently used treatments do not work fully in all cases, patients are being asked to volunteer to take part in a gene transfer research study using special immune cells.
The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancers. This research study combines two different ways of fighting disease: antibodies and T cells. Antibodies are types of proteins that protect the body from infectious diseases and possibly cancer. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including cells infected with viruses and tumor cells. Both antibodies and T cells have been used to treat patients with cancers. They have shown promise, but have not been strong enough to cure most patients.
Read more
The antibody used in this study is called anti-CD19. This antibody sticks to lymphoma cells because of a substance on the outside of these cells called CD19. CD19 antibodies have been used to treat people with lymphoma and CLL. For this study, the anti-CD19 antibody has been changed so that instead of floating free in the blood it is now attached to T cells. When an antibody is joined to a T cell in this way it is called a chimeric receptor. These chimeric receptor-T cells seem to be able to kill tumors, but they don't last very long and so their chances of fighting the cancer are limited.
Investigators found that T cells work better if they also attach a protein called CD28 to the T cells. This protein makes the T cells more active and survive longer.
Also they found that T cells that are also trained to recognize the virus that causes infectious mononucleosis (called Epstein Barr Virus or EBV) can stay in the blood stream for many years.
These CD19-CD28 chimeric receptor T cells and CD19 chimeric-EBV specific T cells are investigational products not approved by the FDA.
The purpose of this study is to find the biggest dose of chimeric T cells that is safe to administer, to see how long each of the T cell populations (CD19-CD28 and CD19-EBV-specific) last, to assess what the side effects are, and to evaluate whether this therapy might help people with lymphoma or CLL.
Read the detailed description
The patient or their donor will give us blood to make CD19-CD28 chimeric receptor T cells and CD19 chimeric-EBV specific T cells in the laboratory. These cells are grown and frozen for the patient. Because the patient will have received cells with a new gene in them they will be followed for a total of 15 years to see if there are any long term side effects of gene transfer.
The patient will be assigned a dose of CD19-CD28 chimeric receptor-T cells and CD19 chimeric receptor-EBV specific T cells. Several studies suggest that the infused T cells need room to be able to proliferate and accomplish their functions and that this may not happen if there are too many other T cells in circulation. Because of that, if the patient's level of circulating T cells is relatively high, they will receive one treatment of cyclophosphamide. This drug will decrease the numbers of the patient's own T cells before the infusion the CD19 chimeric receptor T cells. Although it's not expected to have any effect on the tumor with the dose that the subject will receive, this drug is part of many regimens that are used to treat lymphoma or CLL. If the subject is already receiving chemotherapy, this may not be needed.
The patient will be given an injection of cells into the vein through an IV line at the assigned dose. The patient will be followed in the clinic after the injection for up to 3 hours. If after a 4-6 week evaluation period after the infusion, the patient seems to be experiencing a benefit (confirmed by radiological studies, physical exam and/or symptoms), they may be able to receive up to three additional doses of the T cells. These additional infusions would be at least 4-6 weeks apart and at the same dose level the patient received the first time.
- Conditions
- Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia
- Being tested
- autologous or syngeneic PBTLs and EBV-CTLs
- Keywords
- refractory, relapsed, low, intermediate-grade, Non-Hodgkin lymphoma, Chronic Lymphocytic Leukemia
- Medical subject headings
- Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, Chronic, B-Cell, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous or syngeneic PBTLs and EBV-CTLsBiological
Three dose levels are being evaluated namely:
GROUP 1
PBTL CD19CAR-28 zeta 2x10exp7 cells/m2 and EBV-CTL CD19CAR zeta 2x10exp7 cells/m2
GROUP 2
PBTL CD19CAR-28 zeta 1x10exp8cells/m2 and EBV-CTL CD19CAR zeta 1x10exp8 cells/m2
GROUP 3
PBTL CD19CAR-28 zeta 2x10exp8 cells/m2 and EBV-CTL CD19CAR zeta 2x10exp8 cells/m2
| Study group | Role | What they receive |
|---|---|---|
| autologous or syngeneic PBTLs and EBV-CTLs | Experimental | The subject will be assigned a dose of CD19-CD28 chimeric receptor T cells at study entry. Receives: Biological: autologous or syngeneic PBTLs and EBV-CTLs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with dose limiting toxicity
Dose-limiting toxicity is defined as development of NCI grade III - IV non-hematologic or grade IV hematologic toxicity that can be attributed to the study treatment
Measured: 6 weeks
Secondary outcomes (2)
Survival and function of CD19CAR PBTLs and EBV-CTLs
To measure the differential survival and function of CD19CAR transduced PBTLs and EBV-CTLs in vivo, in particular to determine if CD19CAR transduced EBV-CTLs survive longer than CD19CAR-CD28 transduced PBTLs.
Measured: 15 years
Number of patients with tumor response
To measure the anti-tumor effects of CD19CAR transduced T- lymphocytes in patients with low and intermediate-grade NHL or B-CLL.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2008 (estimated)
- Study startJul 2009
- Primary completionMay 2012
- Study completionMay 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Hodgkin LymphomaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Cell and Gene Therapy, Baylor College of Medicine, The Methodist Hospital Research Institute
- Responsible party
- Principal investigator, Carlos Ramos, Baylor College of Medicine
- Investigators
- Carlos Ramos, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00709033
- Sponsor's protocol ID
- 22899-ATECRAB
- Other IDs
- ATECRAB
- Acronym
- ATECRAB
- Status last verified
- Jan 2026
- First submitted
- 1 Jul 2008
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Xu Y, Zhang M, Ramos CA, Durett A, Liu E, Dakhova O, Liu H, Creighton CJ, Gee AP, Heslop HE, Rooney CM, Savoldo B, Dotti G. Closely related T-memory stem cells correlate with in vivo expansion of CAR.CD19-T cells and are preserved by IL-7 and IL-15. Blood. 2014 Jun 12;123(24):3750-9. doi: 10.1182/blood-2014-01-552174. Epub 2014 Apr 29.
PubMed 24782509
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study Of The Administration Of Peripheral Activated T-Cells and EBV Specific CTLs Expressing CD19 Chimeric Receptors For Advanced B-Cell Non-Hodgkin's Lymphoma And Chronic Lymphocytic Leukemia (ATECRAB)
- ClinicalTrials.gov ID
- NCT00709033
- Acronym / sponsor ID
- ATECRAB / 22899-ATECRAB
- Conditions
- Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia
- Keywords
- refractory, relapsed, low, intermediate-grade, Non-Hodgkin lymphoma, Chronic Lymphocytic Leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Center for Cell and Gene Therapy, Baylor College of Medicine, The Methodist Hospital Research Institute
- Study start
- Jul 2009
- Primary completion
- May 2012 (actual)
- Study completion
- May 2025 (actual)
- First posted
- 3 Jul 2008 (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.
Patients on this study have a type of lymph gland cancer called non-Hodgkin Lymphoma or chronic Lymphocytic Leukemia. Their lymphoma or CLL has come back or has not gone away after treatment. Because there is no standard treatment for the cancer at this time or because the currently used treatments do not work fully in all cases, patients are being asked to volunteer to take part in a gene transfer research study using special immune cells.
The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancers. This research study combines two different ways of fighting disease: antibodies and T cells. Antibodies are types of proteins that protect the body from infectious diseases and possibly cancer. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including cells infected with viruses and tumor cells. Both antibodies and T cells have been used to treat patients with cancers. They have shown promise, but have not been strong enough to cure most patients.
The antibody used in this study is called anti-CD19. This antibody sticks to lymphoma cells because of a substance on the outside of these cells called CD19. CD19 antibodies have been used to treat people with lymphoma and CLL. For this study, the anti-CD19 antibody has been changed so that instead of floating free in the blood it is now attached to T cells. When an antibody is joined to a T cell in this way it is called a chimeric receptor. These chimeric receptor-T cells seem to be able to kill tumors, but they don't last very long and so their chances of fighting the cancer are limited.
Investigators found that T cells work better if they also attach a protein called CD28 to the T cells. This protein makes the T cells more active and survive longer.
Also they found that T cells that are also trained to recognize the virus that causes infectious mononucleosis (called Epstein Barr Virus or EBV) can stay in the blood stream for many years.
These CD19-CD28 chimeric receptor T cells and CD19 chimeric-EBV specific T cells are investigational products not approved by the FDA.
The purpose of this study is to find the biggest dose of chimeric T cells that is safe to administer, to see how long each of the T cell populations (CD19-CD28 and CD19-EBV-specific) last, to assess what the side effects are, and to evaluate whether this therapy might help people with lymphoma or CLL.
Detailed description
The patient or their donor will give us blood to make CD19-CD28 chimeric receptor T cells and CD19 chimeric-EBV specific T cells in the laboratory. These cells are grown and frozen for the patient. Because the patient will have received cells with a new gene in them they will be followed for a total of 15 years to see if there are any long term side effects of gene transfer.
The patient will be assigned a dose of CD19-CD28 chimeric receptor-T cells and CD19 chimeric receptor-EBV specific T cells. Several studies suggest that the infused T cells need room to be able to proliferate and accomplish their functions and that this may not happen if there are too many other T cells in circulation. Because of that, if the patient's level of circulating T cells is relatively high, they will receive one treatment of cyclophosphamide. This drug will decrease the numbers of the patient's own T cells before the infusion the CD19 chimeric receptor T cells. Although it's not expected to have any effect on the tumor with the dose that the subject will receive, this drug is part of many regimens that are used to treat lymphoma or CLL. If the subject is already receiving chemotherapy, this may not be needed.
The patient will be given an injection of cells into the vein through an IV line at the assigned dose. The patient will be followed in the clinic after the injection for up to 3 hours. If after a 4-6 week evaluation period after the infusion, the patient seems to be experiencing a benefit (confirmed by radiological studies, physical exam and/or symptoms), they may be able to receive up to three additional doses of the T cells. These additional infusions would be at least 4-6 weeks apart and at the same dose level the patient received the first time.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| autologous or syngeneic PBTLs and EBV-CTLs | Experimental | Biological: autologous or syngeneic PBTLs and EBV-CTLsThe subject will be assigned a dose of CD19-CD28 chimeric receptor T cells at study entry. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (17 listed)
- Recurrent low or intermediate grade B-cell lymphoma or B-CLL, or newly diagnosed patients unable to receive or complete standard therapy OR diagnosis of relapsed/refractory intermediate B cell lymphoma with a treatment plan that will include high dose therapy and autologous stem cell transplantation.
- CD19-positive tumor
- EBV seropositivity (in patient and donor, as applicable)
- Recovered from the acute toxic effects of all prior chemotherapy at least a week before entering this study.
- Not be currently receiving any investigational agents or have not received any tumor vaccines within the previous six weeks.
Key exclusion criteria (4 listed)
- History of hypersensitivity reactions to murine protein-containing products.
- Pregnant or lactating.
- Tumor in a location where enlargement could cause airway obstruction.
- Active infection with HIV, HBV, HCV or CMV.
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 |
|---|---|---|
| autologous or syngeneic PBTLs and EBV-CTLsThree dose levels are being evaluated namely: GROUP 1 PBTL CD19CAR-28 zeta 2x10exp7 cells/m2 and EBV-CTL CD19CAR zeta 2x10exp7 cells/m2 GROUP 2 PBTL CD19CAR-28 zeta 1x10exp8cells/m2 and EBV-CTL CD19CAR zeta 1x10exp8 cells/m2 GROUP 3 PBTL CD19CAR-28 zeta 2x10exp8 cells/m2 and EBV-CTL CD19CAR zeta 2x10exp8 cells/m2 | Biological | autologous or syngeneic PBTLs and EBV-CTLs |
Primary outcome
Number of patients with dose limiting toxicity
Time frame: 6 weeks
Dose-limiting toxicity is defined as development of NCI grade III - IV non-hematologic or grade IV hematologic toxicity that can be attributed to the study treatment
2 secondary outcomes
Survival and function of CD19CAR PBTLs and EBV-CTLs
Time frame: 15 years
Number of patients with tumor response
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Derived from this study: PubMed 24782509Xu Y, Zhang M, Ramos CA, Durett A, Liu E, Dakhova O, Liu H, Creighton CJ, Gee AP, Heslop HE, Rooney CM, Savoldo B, Dotti G. Closely related T-memory stem cells correlate with in vivo expansion of CAR.CD19-T cells and are preserved by IL-7 and IL-15. Blood. 2014 Jun 12;123(24):3750-9. doi: 10.1182/blood-2014-01-552174. Epub 2014 Apr 29.
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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.
Carlos Ramos, 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 autologous or syngeneic PBTLs and EBV-CTLs in people with Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia, 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 17 inclusion and 4 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: finished, as of the sponsor's last update on 30 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 patients with dose limiting toxicity (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 NCT00709033, which also lists 1 linked publication.
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 30 Jan 2026; AzTrials last refreshed its copy on 31 Oct 2026.