Extranodal Natural Killer/T-Cell Lymphoma, Nasal TypePhase 1NCT04952584
Allogeneic CD30 Chimeric Antigen Receptor Epstein-Barr Virus-Specific T Lymphocytes in Relapsed or Refractory CD30-Positive Lymphomas
A Phase 1 study testing CD30.CAR-EBVST cells in people with Extranodal Natural Killer/T-Cell Lymphoma, Nasal Type and Classical Hodgkin Lymphoma, run by Baylor College of Medicine at 2 sites in United States.
Trial summary
This study involved patients that have a cancer called diffuse large B cell lymphoma (DLBCL), NK and T cell lymphomas (NK/TL) or classical Hodgkin lymphoma (cHL) (hereafter these 3 diseases will be referred to as lymphoma). Patients lymphoma has come back or not gone away after treatment. Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Extranodal Natural Killer/T-Cell Lymphoma, Nasal Type, Classical Hodgkin Lymphoma
- What is being tested?
- CD30.CAR-EBVST cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2024to Jun 2040
- 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 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis and clinical course falling into one of the following categories:
- Hodgkin lymphoma
- Aggressive non-Hodgkin lymphoma
- ALK-negative anaplastic T cell lymphoma or other peripheral T-cell lymphoma
- ALK-positive anaplastic T cell lymphoma
- CD30-positive tumor as assayed in a CLIA certified Pathology Laboratory.
Show all 17Show fewer
- Age 12 to 75.
- Bilirubin 2 times (or 3 times if the patient has Gilbert syndrome) or less than the upper limit of normal.
- AST 3 times or less than the upper limit of normal.
- Estimated GFR > 70 mL/min.
- Pulse oximetry of > 90% on room air
- EKG shows no significant arrhythmias
- Karnofsky or Lansky score of > 60%.
- Available allogeneic T cells with ≥15% expression of CD30CAR determined by flow-cytometry.
- Recovered from all acute non-hematologic toxic effects of all prior chemotherapy.
- 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.
- Informed consent explained to, understood by and signed by patient or guardian. Patient or guardian given a copy of the informed consent form.
Who cannot join
- Currently receiving any investigational agents or received any tumor vaccines within the previous six weeks.
- Received CD30 antibody-based therapy within the previous 4 weeks.
- 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 at a dose equivalent to higher than 10 mg/day of prednisone.
- Active significant, uncontrolled bacterial, viral or fungal infection.
- Symptomatic cardiac disease (NYHA Class III or IV disease).
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: A Phase 1 Study Evaluating the Safety and Activity of Allogeneic CD30 Chimeric Antigen Receptor Epstein-Barr Virus-Specific T Lymphocytes (CD30.CAR-EBVSTs) in Patients With Relapsed or Refractory CD30-Positive Lymphomas
This study involved patients that have a cancer called diffuse large B cell lymphoma (DLBCL), NK and T cell lymphomas (NK/TL) or classical Hodgkin lymphoma (cHL) (hereafter these 3 diseases will be referred to as lymphoma). Patients lymphoma has come back or not gone away after treatment. Because there is no standard treatment for the patients cancer at this time or because the currently used treatments do not work fully in all cases, the patients are being asked to volunteer in this research study.
In this study the investigators want to test a type of T cell made from a normal donor. The T cells the investigators will use are called Epstein Barr virus (EBV) specific T cells (EBVSTs) and are cells that the investigators have trained in the laboratory to recognize a EBV which is the virus that causes mono or kissing disease. Some patients with lymphoma have EBV in their cancer cells. Researchers have given T cell lines from normal donor EBVSTs to lymphoma patients who have EBV in their lymphoma cells and have seen responses in about half the patients. The cells have have been generated and are frozen in a bank. The cells are called "allogeneic" (meaning the donor is not related to the patient). CD30.CAR in EBV-specific T cells (called allogeneic CD30.CAR-EBVST) from the blood of healthy donors. The investigators are giving the cells to patients with lymphoma cells that express CD30. If the lymphoma cells also express EBV there may be some benefit from targeting both proteins.
The purpose of this study is to find out the highest safe dose of allogeneic CD30.CAR-EBVST cells given following chemotherapy and used to treat lymphoma. The investigators will learn the side effects of CD30.CAR-EBVST cells in patients and see whether this therapy may help lymphoma patients.
Read the detailed description
Earlier, healthy donors gave blood for us to make CD30.CAR-EBVST cells in the laboratory. These cells were grown and frozen and the investigators will select the donor which the investigators think is the best match for the patient. This is a dose escalation study. This means that at the beginning, patients will be started on the lowest dose (1 of 3 different levels) of CD30.CAR-EBVST cells. Once the lower dose schedule proves safe, the next group of patients will be started at a higher dose. This process will continue until all 3 dose levels are studied. If the side effects are too severe, the dose will be lowered or the T cell infusion will be stopped. Both the risks and benefits of this study may be dose related. The investigators don't know the best dose that will provide benefit while minimizing the risks.
To enroll on this study, patients will need to have recovered from toxic effects of previous chemotherapy and not be receiving any other investigational agents. Patients cannot have received any tumor vaccines within the previous six weeks.
If patients agree to take part in this study, the investigators will ask the patients to adhere to the following study visits and procedure. After patients have signed the consent form, patients are required to come to the hospital for a series of standard medical screening tests, lymphodepletion chemotherapy with cyclophosphamide and fludarabine, infusion with CD30.CAR-EBVST cell treatment and follow-up visits (See details below).
- Screening tests Screening tests include:
- Blood tests [Human Leukocyte Antigen (HLA) testing] to help us identify the best match for the patient from the banked CD30.CAR-EBVST cells.
- Blood tests for viruses such as human immunodeficiency virus [HIV], human T cell lymphotropic virus [HTLV], hepatitis B virus and hepatitis C virus.
- Tumor biopsy test to check the status of CD30. Once the investigators find that patients are eligible for this study, patients will be called for additional screening tests before treatment day. The screening tests include:
- Physical examination
- Vital signs tests to measure temperature, pulse, respiratory rate and blood pressure
- Blood tests to measure blood cells, kidney and liver functions
- Urine test
- Pregnancy test for women of child-bearing potential
- Measurements of tumor by routine imaging studies
- Lymphodepletion chemotherapy Several studies suggest that the infused T cells need room to be able to multiply and grow to accomplish their functions and that this may not happen if there are too many other T cells in the blood stream. Because of that, if patients have NOT had a bone marrow or stem cell transplant recently, patients will receive treatment with cyclophosphamide and fludarabine (chemotherapy drugs) before patients receive the CD30.CAR-EBVST cells if patients doctor thinks this is appropriate. This is called "lymphodepletion". These drugs will decrease the numbers of patients own T cells before the investigators inject the CD30.CAR-EBVST cells. Although the investigators do not expect any effect on the patients tumor with the dose that the patients will receive, these drugs are part of many regimens that are used to treat lymphoma.
- Treatment with CD30.CAR-EBVST cells Patients will be given one injection of CD30.CAR-EBVST cells. The CD30.CAR-EBVST cells will be injected into the vein through an IV line at the assigned dose. Before patients receive the injection, patients may be given a dose of acetaminophen or anti-histamine (Benadryl for example) to minimize any possible allergic reaction. The injection of CD30.CAR-EBVST cells will take within 10 minutes. The investigators will follow patients in the clinic after each injection for up to 3 hours. The patient will need to stay less than 2 hours away from the Medical Center for 4 weeks after the CD30.CAR-EBVST cell infusion so the investigator can monitor them for side effects. At the discretion of the study doctor, if patients have stable disease (the lymphoma did not grow) or there is a reduction in the size of the patients lymphoma on imaging studies at week 6 after T-cell infusion or on subsequent evaluations, then patients may receive up to two additional doses of the CD30.CAR-EBVST cells at approximately 6 weeks intervals if patients wish to. Lymphodepletion chemotherapy may also be administered before additional doses of CD30.CAR-EBVST infusion. After each T-cell infusion, patients will be monitored to ensure that participants don't have a reaction to the infusion.
- Follow-up visits
On follow-up visits after treatment, patients will also receive a series of standard medical tests:
- Physical examination
- Vital sign tests to measure temperature, pulse, respiratory rate and blood pressure
- Blood tests to measure blood cells, kidney and liver functions
- Urine tests (if clinically necessary)
- Pregnancy test for women of child-bearing potential (if clinically necessary)
- Measurements of tumor by routine imaging studies
After infusion of CD30.CAR-EBVST cells,the patients blood will be collected on follow-up visits at week 1, week 2, week 3, week 4, week 8, every 3 months for 1 year, every 6 months for 4 more years. Blood samples and tumor biopsies will also be periodically collected, based on the patients doctor's discretion for exploratory tests in the laboratory. After 5 years, in the event there is suspected or new cancer is detected, additional blood sample will also be collected for additional tests.
To learn more about the way the CD30.CAR-EBVST cells are working and how long they last in the body, the investigators will draw blood. The total amount of blood collected on any day is about 4-18 teaspoons (18-87 ml). This volume is considered safe but may be decreased if the patients are anemic. Patients blood will be drawn from a central line if participants have one. The total blood drawn during the patients participation in this study will not exceed 110 teaspoons (546 ml).
The investigators will also look at any scans or biopsies patients have had as standard of care.
- Being tested
- CD30.CAR-EBVST cells
- Keywords
- CD30-Positive Lymphoma, Hodgkin lymphoma, Non-Hodgkin lymphoma, CD30 CAR
- Medical subject headings
- Lymphoma, Extranodal NK-T-Cell, Hodgkin Disease, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD30.CAR-EBVST cellsBiological
Also called Allogeneic CD30 Chimeric Antigen Receptor Epstein-Barr Virus-Specific T Lymphocytes
The dose is based on the number of CD30.CAR-expressing cells. In our previous study the highest dose was 2 × 10^8 cells/m2 and we did not reach a MTD.
There will be a gap of 4 weeks between the first and second patient on each dose level.
On Day 0 of study, patients will receive their planned single dose of investigational T cell product by IV infusion over approximately 1 to 10 minutes in an expected volume of 1 to 50 mL.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Phase | Experimental | Three dose levels will be evaluated based on safety data from our current study of CD30 CAR T cells. Cohorts of three to six patients will be enrolled at each dose level The dose is based on the number of CD.30 CAR-EBVT-expressing cells administered. The total number of dose levels evaluated will depend upon toxicities experienced. Dose level cohorts will be numbered sequentially.
Dose Level 1: 1 × 10^8 CD30.CAR-EBVST cells
Dose Level 2: 4 × 10^8 CD30.CAR-EBVST cells
Dose Level 3: 1 × 10^9 CD30.CAR-EBVST cells Receives: Biological: CD30.CAR-EBVST cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity rate (DLT) by CTCAE 5.0
Any Grade 5 event, / Non-hematologic dose-limiting toxicity is any Grade 3 or Grade 4 non-hematologic toxicity that fails to return to Grade 2 within 72 hours, / Grade 2-4 allergic reaction to T-Cells, / Grade 3-4 GVHD, / Grade 3-4 CRS. Toxicity will be evaluated according to the CTCAE Version 5.0. GVHD will be graded by the method of Przepiorka et al.
Measured: 28 Days
Secondary outcomes (5)
Rate of Anti-Tumor effect Objective Response (OR)
Objective response rate is defined as complete response and partial response
Measured: 4 to 12 weeks post CTL infusion
Duration of Response
Response duration will be measured from the time of initial response until documented tumor progression.
Measured: Up to 5 years
Stable disease (SD) rate
SD will be defined as the proportion of patients that have stable disease
Measured: 4 to 12 weeks post CTL infusion
Duration of SD
Stable disease is measured from the start of the treatment until the criteria for progression are met.
Measured: Up to 5 years
Progression free survival (PFS)
PFS is defined as the time from treatment until objective tumor progression or death, whichever occurs first.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study startMar 2024 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionJun 2040 (estimated)
Why it stopped: Study was not activated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extranodal Natural Killer/T-Cell Lymphoma, Nasal TypeStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The Methodist Hospital Research Institute
- Responsible party
- Principal investigator, Premal Lulla, Baylor College of Medicine
- Investigators
- Premal Lulla, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04952584
- Sponsor's protocol ID
- H-49736 TESTA
- Status last verified
- Sep 2023
- First submitted
- 28 Jun 2021
- Last updated
- 7 Sep 2023
- 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 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study Evaluating the Safety and Activity of Allogeneic CD30 Chimeric Antigen Receptor Epstein-Barr Virus-Specific T Lymphocytes (CD30.CAR-EBVSTs) in Patients With Relapsed or Refractory CD30-Positive Lymphomas
- ClinicalTrials.gov ID
- NCT04952584
- Acronym / sponsor ID
- H-49736 TESTA
- Keywords
- CD30-Positive Lymphoma, Hodgkin lymphoma, Non-Hodgkin lymphoma, CD30 CAR
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was not activated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- The Methodist Hospital Research Institute
- Study start
- Mar 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2040 (estimated)
- First posted
- 7 Jul 2021 (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 study involved patients that have a cancer called diffuse large B cell lymphoma (DLBCL), NK and T cell lymphomas (NK/TL) or classical Hodgkin lymphoma (cHL) (hereafter these 3 diseases will be referred to as lymphoma). Patients lymphoma has come back or not gone away after treatment. Because there is no standard treatment for the patients cancer at this time or because the currently used treatments do not work fully in all cases, the patients are being asked to volunteer in this research study.
In this study the investigators want to test a type of T cell made from a normal donor. The T cells the investigators will use are called Epstein Barr virus (EBV) specific T cells (EBVSTs) and are cells that the investigators have trained in the laboratory to recognize a EBV which is the virus that causes mono or kissing disease. Some patients with lymphoma have EBV in their cancer cells. Researchers have given T cell lines from normal donor EBVSTs to lymphoma patients who have EBV in their lymphoma cells and have seen responses in about half the patients. The cells have have been generated and are frozen in a bank. The cells are called "allogeneic" (meaning the donor is not related to the patient). CD30.CAR in EBV-specific T cells (called allogeneic CD30.CAR-EBVST) from the blood of healthy donors. The investigators are giving the cells to patients with lymphoma cells that express CD30. If the lymphoma cells also express EBV there may be some benefit from targeting both proteins.
The purpose of this study is to find out the highest safe dose of allogeneic CD30.CAR-EBVST cells given following chemotherapy and used to treat lymphoma. The investigators will learn the side effects of CD30.CAR-EBVST cells in patients and see whether this therapy may help lymphoma patients.
Detailed description
Earlier, healthy donors gave blood for us to make CD30.CAR-EBVST cells in the laboratory. These cells were grown and frozen and the investigators will select the donor which the investigators think is the best match for the patient. This is a dose escalation study. This means that at the beginning, patients will be started on the lowest dose (1 of 3 different levels) of CD30.CAR-EBVST cells. Once the lower dose schedule proves safe, the next group of patients will be started at a higher dose. This process will continue until all 3 dose levels are studied. If the side effects are too severe, the dose will be lowered or the T cell infusion will be stopped. Both the risks and benefits of this study may be dose related. The investigators don't know the best dose that will provide benefit while minimizing the risks.
To enroll on this study, patients will need to have recovered from toxic effects of previous chemotherapy and not be receiving any other investigational agents. Patients cannot have received any tumor vaccines within the previous six weeks.
If patients agree to take part in this study, the investigators will ask the patients to adhere to the following study visits and procedure. After patients have signed the consent form, patients are required to come to the hospital for a series of standard medical screening tests, lymphodepletion chemotherapy with cyclophosphamide and fludarabine, infusion with CD30.CAR-EBVST cell treatment and follow-up visits (See details below).
- Screening tests Screening tests include:
- Blood tests [Human Leukocyte Antigen (HLA) testing] to help us identify the best match for the patient from the banked CD30.CAR-EBVST cells.
- Blood tests for viruses such as human immunodeficiency virus [HIV], human T cell lymphotropic virus [HTLV], hepatitis B virus and hepatitis C virus.
- Tumor biopsy test to check the status of CD30. Once the investigators find that patients are eligible for this study, patients will be called for additional screening tests before treatment day. The screening tests include:
- Physical examination
- Vital signs tests to measure temperature, pulse, respiratory rate and blood pressure
- Blood tests to measure blood cells, kidney and liver functions
- Urine test
- Pregnancy test for women of child-bearing potential
- Measurements of tumor by routine imaging studies
- Lymphodepletion chemotherapy Several studies suggest that the infused T cells need room to be able to multiply and grow to accomplish their functions and that this may not happen if there are too many other T cells in the blood stream. Because of that, if patients have NOT had a bone marrow or stem cell transplant recently, patients will receive treatment with cyclophosphamide and fludarabine (chemotherapy drugs) before patients receive the CD30.CAR-EBVST cells if patients doctor thinks this is appropriate. This is called "lymphodepletion". These drugs will decrease the numbers of patients own T cells before the investigators inject the CD30.CAR-EBVST cells. Although the investigators do not expect any effect on the patients tumor with the dose that the patients will receive, these drugs are part of many regimens that are used to treat lymphoma.
- Treatment with CD30.CAR-EBVST cells Patients will be given one injection of CD30.CAR-EBVST cells. The CD30.CAR-EBVST cells will be injected into the vein through an IV line at the assigned dose. Before patients receive the injection, patients may be given a dose of acetaminophen or anti-histamine (Benadryl for example) to minimize any possible allergic reaction. The injection of CD30.CAR-EBVST cells will take within 10 minutes. The investigators will follow patients in the clinic after each injection for up to 3 hours. The patient will need to stay less than 2 hours away from the Medical Center for 4 weeks after the CD30.CAR-EBVST cell infusion so the investigator can monitor them for side effects. At the discretion of the study doctor, if patients have stable disease (the lymphoma did not grow) or there is a reduction in the size of the patients lymphoma on imaging studies at week 6 after T-cell infusion or on subsequent evaluations, then patients may receive up to two additional doses of the CD30.CAR-EBVST cells at approximately 6 weeks intervals if patients wish to. Lymphodepletion chemotherapy may also be administered before additional doses of CD30.CAR-EBVST infusion. After each T-cell infusion, patients will be monitored to ensure that participants don't have a reaction to the infusion.
- Follow-up visits
On follow-up visits after treatment, patients will also receive a series of standard medical tests:
- Physical examination
- Vital sign tests to measure temperature, pulse, respiratory rate and blood pressure
- Blood tests to measure blood cells, kidney and liver functions
- Urine tests (if clinically necessary)
- Pregnancy test for women of child-bearing potential (if clinically necessary)
- Measurements of tumor by routine imaging studies
After infusion of CD30.CAR-EBVST cells,the patients blood will be collected on follow-up visits at week 1, week 2, week 3, week 4, week 8, every 3 months for 1 year, every 6 months for 4 more years. Blood samples and tumor biopsies will also be periodically collected, based on the patients doctor's discretion for exploratory tests in the laboratory. After 5 years, in the event there is suspected or new cancer is detected, additional blood sample will also be collected for additional tests.
To learn more about the way the CD30.CAR-EBVST cells are working and how long they last in the body, the investigators will draw blood. The total amount of blood collected on any day is about 4-18 teaspoons (18-87 ml). This volume is considered safe but may be decreased if the patients are anemic. Patients blood will be drawn from a central line if participants have one. The total blood drawn during the patients participation in this study will not exceed 110 teaspoons (546 ml).
The investigators will also look at any scans or biopsies patients have had as standard of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Phase | Experimental | Biological: CD30.CAR-EBVST cellsThree dose levels will be evaluated based on safety data from our current study of CD30 CAR T cells. Cohorts of three to six patients will be enrolled at each dose level The dose is based on the number of CD.30 CAR-EBVT-expressing cells administered. The total number of dose levels evaluated will depend upon toxicities experienced. Dose level cohorts will be numbered sequentially. Dose Level 1: 1 × 10^8 CD30.CAR-EBVST cells Dose Level 2: 4 × 10^8 CD30.CAR-EBVST cells Dose Level 3: 1 × 10^9 CD30.CAR-EBVST cells |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (17 listed)
- Diagnosis and clinical course falling into one of the following categories:
- CD30-positive tumor as assayed in a CLIA certified Pathology Laboratory.
- Age 12 to 75.
- Bilirubin 2 times (or 3 times if the patient has Gilbert syndrome) or less than the upper limit of normal.
- AST 3 times or less than the upper limit of normal.
Key exclusion criteria (8 listed)
- Currently receiving any investigational agents or received any tumor vaccines within the previous six weeks.
- Received CD30 antibody-based therapy within the previous 4 weeks.
- History of hypersensitivity reactions to murine protein-containing products.
- Pregnant or lactating.
- Tumor in a location where enlargement could cause airway obstruction.
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 |
|---|---|---|
| CD30.CAR-EBVST cellsAlso: Allogeneic CD30 Chimeric Antigen Receptor Epstein-Barr Virus-Specific T LymphocytesThe dose is based on the number of CD30.CAR-expressing cells. In our previous study the highest dose was 2 × 10^8 cells/m2 and we did not reach a MTD. There will be a gap of 4 weeks between the first and second patient on each dose level. On Day 0 of study, patients will receive their planned single dose of investigational T cell product by IV infusion over approximately 1 to 10 minutes in an expected volume of 1 to 50 mL. | Biological | Treatment Phase |
Primary outcome
Dose limiting toxicity rate (DLT) by CTCAE 5.0
Time frame: 28 Days
Any Grade 5 event, / Non-hematologic dose-limiting toxicity is any Grade 3 or Grade 4 non-hematologic toxicity that fails to return to Grade 2 within 72 hours, / Grade 2-4 allergic reaction to T-Cells, / Grade 3-4 GVHD, / Grade 3-4 CRS. Toxicity will be evaluated according to the CTCAE Version 5.0. GVHD will be graded by the method of Przepiorka et al.
5 secondary outcomes
Rate of Anti-Tumor effect Objective Response (OR)
Time frame: 4 to 12 weeks post CTL infusion
Duration of Response
Time frame: Up to 5 years
Stable disease (SD) rate
Time frame: 4 to 12 weeks post CTL infusion
Duration of SD
Time frame: Up to 5 years
Progression free survival (PFS)
Time frame: Up to 5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
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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.
Premal Lulla, 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 CD30.CAR-EBVST cells in people with Extranodal Natural Killer/T-Cell Lymphoma, Nasal Type and Classical Hodgkin 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 17 inclusion and 8 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: withdrawn, as of the sponsor's last update on 7 Sep 2023. 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 was withdrawn before enrolling participants, so there are no results.
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?
Dose limiting toxicity rate (DLT) by CTCAE 5.0 (time frame: 28 Days). 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 7 Sep 2023.