Hodgkin's LymphomaPhase 1CARCD30NCT01192464
EBV CTLs Expressing CD30 Chimeric Receptors For CD 30+ Lymphoma
A Phase 1 study testing autologous CAR.CD30 EBV specific-CTLs in people with Hodgkin's Lymphoma and Non-Hodgkin's Lymphoma, run by Baylor College of Medicine at 2 sites in United States.
Trial summary
The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancer. This research study combines two different ways of fighting disease: antibodies and T cells. Antibodies are proteins the protect the body from diseases caused by germs or toxic substances. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma
- What is being tested?
- autologous CAR.CD30 EBV specific-CTLs
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 May 2011to Oct 2033
- 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
- PROCUREMENT Inclusion Criteria:
- Referred patients will initially be consented for procurement of blood for generation of the transduced CTL Line. Eligibility criteria at this stage include:
- Diagnosis of recurrent HL or NHL, or newly diagnosed patients unable to receive or complete standard therapy OR diagnosis of relapsed/refractory HL or NHL with a treatment plan that will include high dose therapy and stem cell transplantation
- CD30 positive tumor (can be pending at this time)
- EBV seropositivity (can be pending at this time)
- Hgb > 8.0
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- Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.
- TREAMENT Inclusion Criteria: Patients must meet the following eligibility criteria to be included for treatment:
- Diagnosis - CD30+ HL or CD30+ NHL
- During the dose escalation phase: only adult patients (age 18 and older) with active disease failing standard therapy
- After dose escalation: any patient (children or adults) with relapsed CD30+ HL or CD30+ NHL or newly diagnosed patients unable to receive or complete standard therapy OR diagnosis of relapsed/refractory CD30+ HL or CD30+ NHL with a treatment plan that will include high dose therapy and autologous stem cell transplantation.
- CD30 positive tumor
- EBV seropositivity.
- Recovered from acute toxic effects of all prior chemotherapy at least one week and 30 days from prior chemotherapy before entering this study.
- Bilirubin 1.5 times or less than upper limit of normal.
- AST 3 times or less than upper limit of normal.
- Serum creatinine 1.5 times or less than upper limit of normal.
- Pulse oximetry of > 90% on room air
- Karnofsky or Lansky score of > 60%.
- Available autologous transduced EBV-specific cytotoxic T lymphocytes with 15% or more expression of CD30CAR determined by flow-cytometry.
- Adequate pulmonary function with FEV1, FVC and DLCO 50% or greater of expected corrected for hemoglobin. Exceptions may be allowed for patients with pulmonary involvement after discussing with PI.
- Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after the study is concluded. The male partner should use a condom.
- Patients or legal guardians must 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.
Who cannot join
- PROCUREMENT Exclusion Criteria:
- Active infection with HIV, HTLV, HBV, HCV (can be pending at this time).
- Received rituximab within 4 months of blood collection for LCL initiation (unless circulating CD19+ B are =/>2%)
- TREATMENT Exclusion Criteria:
- Currently receiving any investigational agents or received any tumor vaccines within the previous six weeks.
- Received anti-CD30 antibody-based therapy within the previous 6 weeks.
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- History of hypersensitivity reactions to murine protein-containing products.
- Pregnant or lactating.
- Tumor in a location where enlargement could cause airway obstruction.
- Current use of systemic corticosteroids.
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 EBV CTLs Expressing CD30 Chimeric Receptors for Relapsed CD30+ Hodgkin's Lymphoma and CD30+ Non-Hodgkin's Lymphoma (CAR CD 30)
The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancer. This research study combines two different ways of fighting disease: antibodies and T cells. Antibodies are proteins the protect the body from diseases caused by germs or toxic substances. They work by binding those germs or substances, which stops them from growing and causing bad effects. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including tumor cells or cells that are infected with germs. Both antibodies and T cells have been used to treat patients with cancers: they both have been shown promise, but have not been strong enough to cure most patients. This study combines the two methods.
We have found from previous research that we can put a new gene into T cells that will make them recognize cancer cells and kill them. We now want to see if we can attach a new gene to T cells that will help them do a better job at recognizing and killing lymphoma cells.
Read more
The new gene we will put in T cells makes an antibody called anti-CD30. The antibody alone has not been strong enough to cure most patients. For this study, the anti-CD30 antibody has been changed so that instead of floating free in the blood it is now joined to the 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 kill some of the tumor, but they don't last very long and so their chances of fighting the cancer are unknown.
We have found that T cells that are also trained to recognize the EBV virus (that causes infectious mononucleosis) can stay in the blood stream for many years. These are called EBV specific Cytotoxic T Lymphocytes.
By joining the anti-CD30 antibody to the EBV CTLs, we believe that we will also be able to make a cell that can last a long time in the body and recognize and kill lymphoma cells. We call the final cells CD30 chimeric receptor EBV CTLs. T
We hope that these new cells may be able to work longer and target and kill lymphoma cells. However, we do not know that yet.
Read the detailed description
The EBV CTLs will be made for specific patients. First blood will be collected from the patient and then the the CD30 chimeric-EBV CTLs will be created in the lab. The cells will then be grown and frozen for the patient.
To get the CD30 antibody to attach to the surface of the T cell, the lab will insert the antibody gene 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. 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.
When the patient is enrolled on this study, they will be assigned to one of the following dose levels of CD30 chimeric receptor-EBV CTLs.
- 2×10^7 cells/m2
- 5x10^7 cells/m2
- 1×10^8 cells/m2
The dose level of cells that they will receive will not be based on a medical determination of what is best for them, instead the dose is based on the order in which the patient enrolls on the study relative to other participants. Subjects enrolled earlier in the study will receive a lower dose of cells than those enrolled later in the study. The risks of harm and discomfort from the study treatment may bear some relationship to the dose level. The potential for direct benefit, if any, may also vary with the dose level. To enroll on this study they will need to have recovered from toxic effects of previous chemotherapy for at least one week and not be receiving any other investigational agents. Patients cannot have received any tumor vaccines within the previous six weeks.
- Conditions
- Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma
- Being tested
- autologous CAR.CD30 EBV specific-CTLs
- Keywords
- Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma
- Medical subject headings
- Hodgkin Disease, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous CAR.CD30 EBV specific-CTLsDrug
Also called CD30 EBV CTL
Three dose levels will be evaluated. Using the modified continual reassessment method, cohorts of size two will be enrolled at each dose level. Each patient will receive one injection.
| Study group | Role | What they receive |
|---|---|---|
| autologous CAR.CD30 EBV specific-CTLs | Experimental | Group One Dose (CTLs CAR.CD30) at Day 0: 2x10^7 cells/m2
Group Two Dose (CTLs CAR.CD30) at Day 0: 5x10^7 cells/m2
Group Three Dose (CTLs CAR.CD30) at Day 0: 1x10^8 cells/m2 Receives: Drug: autologous CAR.CD30 EBV specific-CTLs |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety of escalating doses of autologous EBV-specific cytotoxic T-lymphocytes (CTLs),
To evaluate the safety of escalating doses of autologous EBV-specific cytotoxic T-lymphocytes (CTLs), genetically modified to express an artificial T-cell receptor (CAR) targeting the CD30 molecule (CAR.CD30), in patients with CD30+ refractory/relapsed Hodgkin lymphoma (HL) or non-Hodgkin lymphoma (NHL)
Measured: 6 weeks
Secondary outcomes (2)
To measure the survival of CAR.CD30 transduced EBV-CTLs in vivo.
To measure the survival of CAR.CD30 transduced EBV-CTLs in vivo.
Measured: 15 years
To measure the anti-tumor effects of CAR.CD30 transduced CTLs
To measure the anti-tumor effects of CAR.CD30 transduced CTLs in patients with patients with CD30+ refractory/relapsed Hodgkin lymphoma (HL) or non-Hodgkin lymphoma (NHL)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2010 (estimated)
- Study start10 May 2011
- Primary completion29 May 2012
- Study completionOct 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin's 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
- 18 participants (estimated)
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, Helen Heslop, Baylor College of Medicine
- Investigators
- Helen E Heslop, MD, Principal investigator, Baylor College of Medicine/Center for Cell and Gene Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01192464
- Sponsor's protocol ID
- H-26617 CAR CD 30
- Acronym
- CARCD30
- Status last verified
- Feb 2026
- First submitted
- 16 Aug 2010
- Last updated
- 6 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 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of the Administration of EBV CTLs Expressing CD30 Chimeric Receptors for Relapsed CD30+ Hodgkin's Lymphoma and CD30+ Non-Hodgkin's Lymphoma (CAR CD 30)
- ClinicalTrials.gov ID
- NCT01192464
- Acronym / sponsor ID
- CARCD30 / H-26617 CAR CD 30
- Conditions
- Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma
- Keywords
- Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 18 participants (estimated)
- 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
- 10 May 2011 (actual)
- Primary completion
- 29 May 2012 (actual)
- Study completion
- Oct 2033 (estimated)
- First posted
- 1 Sep 2010 (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.
The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancer. This research study combines two different ways of fighting disease: antibodies and T cells. Antibodies are proteins the protect the body from diseases caused by germs or toxic substances. They work by binding those germs or substances, which stops them from growing and causing bad effects. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including tumor cells or cells that are infected with germs. Both antibodies and T cells have been used to treat patients with cancers: they both have been shown promise, but have not been strong enough to cure most patients. This study combines the two methods.
We have found from previous research that we can put a new gene into T cells that will make them recognize cancer cells and kill them. We now want to see if we can attach a new gene to T cells that will help them do a better job at recognizing and killing lymphoma cells.
The new gene we will put in T cells makes an antibody called anti-CD30. The antibody alone has not been strong enough to cure most patients. For this study, the anti-CD30 antibody has been changed so that instead of floating free in the blood it is now joined to the 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 kill some of the tumor, but they don't last very long and so their chances of fighting the cancer are unknown.
We have found that T cells that are also trained to recognize the EBV virus (that causes infectious mononucleosis) can stay in the blood stream for many years. These are called EBV specific Cytotoxic T Lymphocytes.
By joining the anti-CD30 antibody to the EBV CTLs, we believe that we will also be able to make a cell that can last a long time in the body and recognize and kill lymphoma cells. We call the final cells CD30 chimeric receptor EBV CTLs. T
We hope that these new cells may be able to work longer and target and kill lymphoma cells. However, we do not know that yet.
Detailed description
The EBV CTLs will be made for specific patients. First blood will be collected from the patient and then the the CD30 chimeric-EBV CTLs will be created in the lab. The cells will then be grown and frozen for the patient.
To get the CD30 antibody to attach to the surface of the T cell, the lab will insert the antibody gene 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. 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.
When the patient is enrolled on this study, they will be assigned to one of the following dose levels of CD30 chimeric receptor-EBV CTLs.
- 2×10^7 cells/m2
- 5x10^7 cells/m2
- 1×10^8 cells/m2
The dose level of cells that they will receive will not be based on a medical determination of what is best for them, instead the dose is based on the order in which the patient enrolls on the study relative to other participants. Subjects enrolled earlier in the study will receive a lower dose of cells than those enrolled later in the study. The risks of harm and discomfort from the study treatment may bear some relationship to the dose level. The potential for direct benefit, if any, may also vary with the dose level. To enroll on this study they will need to have recovered from toxic effects of previous chemotherapy for at least one week and not be receiving any other investigational agents. Patients cannot have received any tumor vaccines within the previous six weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| autologous CAR.CD30 EBV specific-CTLs | Experimental | Drug: autologous CAR.CD30 EBV specific-CTLsGroup One Dose (CTLs CAR.CD30) at Day 0: 2x10^7 cells/m2 Group Two Dose (CTLs CAR.CD30) at Day 0: 5x10^7 cells/m2 Group Three Dose (CTLs CAR.CD30) at Day 0: 1x10^8 cells/m2 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (23 listed)
- Referred patients will initially be consented for procurement of blood for generation of the transduced CTL Line. Eligibility criteria at this stage include:
- Diagnosis of recurrent HL or NHL, or newly diagnosed patients unable to receive or complete standard therapy OR diagnosis of relapsed/refractory HL or NHL with a treatment plan that will include high dose therapy and stem cell transplantation
- CD30 positive tumor (can be pending at this time)
- EBV seropositivity (can be pending at this time)
- Hgb > 8.0
Key exclusion criteria (10 listed)
- Active infection with HIV, HTLV, HBV, HCV (can be pending at this time).
- Received rituximab within 4 months of blood collection for LCL initiation (unless circulating CD19+ B are =/>2%)
- Currently receiving any investigational agents or received any tumor vaccines within the previous six weeks.
- Received anti-CD30 antibody-based therapy within the previous 6 weeks.
- History of hypersensitivity reactions to murine protein-containing products.
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 CAR.CD30 EBV specific-CTLsAlso: CD30 EBV CTLThree dose levels will be evaluated. Using the modified continual reassessment method, cohorts of size two will be enrolled at each dose level. Each patient will receive one injection. | Drug | autologous CAR.CD30 EBV specific-CTLs |
Primary outcome
To evaluate the safety of escalating doses of autologous EBV-specific cytotoxic T-lymphocytes (CTLs),
Time frame: 6 weeks
To evaluate the safety of escalating doses of autologous EBV-specific cytotoxic T-lymphocytes (CTLs), genetically modified to express an artificial T-cell receptor (CAR) targeting the CD30 molecule (CAR.CD30), in patients with CD30+ refractory/relapsed Hodgkin lymphoma (HL) or non-Hodgkin lymphoma (NHL)
2 secondary outcomes
To measure the survival of CAR.CD30 transduced EBV-CTLs in vivo.
Time frame: 15 years
To measure the anti-tumor effects of CAR.CD30 transduced CTLs
Time frame: 8 weeks
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 6 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. This study is not recruiting at the moment.
Helen E Heslop, MD principal investigator
Baylor College of Medicine/Center for Cell and Gene Therapy
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 CAR.CD30 EBV specific-CTLs in people with Hodgkin's Lymphoma and Non-Hodgkin's Lymphoma, 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 23 inclusion and 10 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 6 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 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?
To evaluate the safety of escalating doses of autologous EBV-specific cytotoxic T-lymphocytes (CTLs), (time frame: 6 weeks). 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 6 Feb 2026.