CD30-Positive Diffuse Large B-Cell LymphomaPhase 1CABAL2NCT06176690
Constitutive IL7R (C7R) Modified Banked Allogeneic CD30.CAR EBVSTS for CD30-Positive Lymphomas
A Phase 1 study testing C7R.CD30.CAR-EBVST cells in people with CD30-Positive Diffuse Large B-Cell Lymphoma and Anaplastic Large Cell Lymphoma, T Cell and Null Cell Type, run by Baylor College of Medicine at 2 sites in United States.
Trial summary
This study involves patients with diffuse large B cell lymphoma (DLBCL), natural killer/T-cell lymphoma (NKTL), or classical Hodgkin lymphoma (cHL) (referred to collectively as lymphoma) whose disease has returned or not responded to treatment. Previous research combined antibodies and T cells to treat cancer. Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- CD30-Positive Diffuse Large B-Cell Lymphoma, Anaplastic Large Cell Lymphoma, T Cell and Null Cell Type, Anaplastic Large Cell Lymphoma, ALK-Positive
- What is being tested?
- C7R.CD30.CAR-EBVST cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Oct 2025to 27 Jun 2043
- 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 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
- CD30+ aggressive B-cell 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.
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- Age 12 to 75.
- Bilirubin less than or equal to 2 times the upper limit of normal (except for Gilbert syndrome, where the criteria will be Bilirubin less than or equal to 3 times the upper limit of normal).
- AST less than 3 times the upper limit of normal.
- Estimated GFR > 70 mL/min.
- Pulse oximetry of > 90% on room air
- Karnofsky or Lansky score of > 60%.
- 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
- Received an investigational cell therapy or vaccine within the past 6 weeks.
- Received an investigational small molecule drug within the past 2 weeks.
- Received anti-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 (determined at the investigators' discretion).
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- Current use of systemic corticosteroids at a dose equivalent to or 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. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Houston Methodist Hospital
Houston, Texas, 77030
Premal Lulla, MD, 713-441-1450, pdlulla@houstonmethodist.org
Vicky Torrano, RN, 832-824-7821, vxtorran@texaschildrens.org
- Not yet recruiting
Texas Children's Hospital
Houston, Texas, 77030
Helen Heslop, MD, hheslop@bcm.edu
Vicky Torrano, RN, 832-824-7821, vxtorran@texaschildrens.org
About this study
Official title: Constitutive IL7R (C7R) Modified Banked 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 involves patients with diffuse large B cell lymphoma (DLBCL), natural killer/T-cell lymphoma (NKTL), or classical Hodgkin lymphoma (cHL) (referred to collectively as lymphoma) whose disease has returned or not responded to treatment.
Previous research combined antibodies and T cells to treat cancer. Antibodies bind to foreign substances, and T cells are infection-fighting white blood cells that can kill tumor cells. Both approaches have shown promise but have not been sufficient to cure most patients. In prior studies, an antibody targeting CD30, a protein found on some T cells and cancer cells, was joined to T cells through gene transfer to create CD30.CAR T cells.
Read more
Another study showed encouraging responses using CD30.CAR T cells made from a patient's own blood and returned to the same patient (autologous cells). In an ongoing study, patients have been treated with CD30.CAR T cells derived from healthy donors (allogeneic cells), allowing use of banked cells without individualized manufacturing. This approach has shown promising clinical activity with no safety concerns to date.
In this study, investigators are evaluating CD30.CAR-EBVST cells modified with an additional molecule called C7R, which has been shown in laboratory studies to enhance anti-cancer effects. The study aims to assess the safety and effectiveness of these allogeneic, banked C7R-modified CD30.CAR-EBVST cells and determine whether they may help treat lymphoma.
As an added safety measure, the modified T cells include a marker called iC9. If significant side effects occur, patients may receive rimiducid, which can eliminate the infused T cells. Rimiducid is not yet FDA approved but has been tested in patients without significant side effects.
Read the detailed description
This is a Phase 1 dose-escalation study evaluating allogeneic C7R.CD30.CAR-EBVST cells in patients with relapsed or refractory CD30-positive lymphoma.
Participants are treated in sequential cohorts at one of four dose levels of C7R.CD30.CAR-EBVST cells. Treatment begins at the lowest dose level, and subsequent cohorts are treated at higher dose levels if the preceding dose is determined to be safe. If significant toxicity is observed, dose escalation may be halted, reduced, or discontinued. The relationship between dose level and both safety and potential clinical benefit is evaluated.
Prior to treatment, participants undergo screening evaluations including laboratory testing, imaging studies, and confirmation of CD30 expression. Human leukocyte antigen (HLA) testing is performed to identify the most appropriate partially matched cell line from a bank of allogeneic C7R.CD30.CAR-EBVST products.
Participants may receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine prior to infusion, as clinically appropriate, to reduce endogenous lymphocytes and support expansion of the infused cells.
C7R.CD30.CAR-EBVST cells are administered as a single intravenous infusion at the assigned dose level. Premedication may be given to reduce the risk of infusion-related reactions. Participants are monitored in the clinical setting following infusion and are required to remain within close proximity to the treatment center for a defined period to allow for monitoring of potential adverse events.
Following treatment, participants undergo scheduled follow-up evaluations including physical examinations, laboratory testing, and imaging studies to assess safety and disease status. Blood samples are collected at multiple time points after infusion to evaluate persistence of the infused cells. Tumor assessments are performed using imaging and, when clinically indicated, biopsy.
Participants demonstrating an objective clinical response following initial dosing may be considered for up to three (3) additional infusions of C7R.CD30.CAR-EBVST cells, at the discretion of the treating clinical team.
Participants are followed longitudinally after treatment, with more frequent assessments early after infusion and less frequent long-term follow-up, for up to 15 years after the most recent infusion.
- Conditions
- CD30-Positive Diffuse Large B-Cell Lymphoma, Anaplastic Large Cell Lymphoma, T Cell and Null Cell Type, Anaplastic Large Cell Lymphoma, ALK-Positive, Peripheral T-cell Lymphoma, Anaplastic Large Cell Lymphoma, ALK-negative, Non-Hodgkin Lymphoma
- Being tested
- C7R.CD30.CAR-EBVST cells
- Keywords
- CD30-Positive Lymphoma, Hodgkin lymphoma, non-Hodgkin lymphoma, CD30 CAR
- Medical subject headings
- Lymphoma, Large-Cell, Anaplastic, Lymphoma, T-Cell, Peripheral, Lymphoma, Non-Hodgkin, Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C7R.CD30.CAR-EBVST cellsBiological
Also called Allogeneic CR7.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 4 × 10^8 cells/m2 and we did not reach an MTD. On Day 0, patients will receive their planned 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 | Four dose levels will be evaluated based on safety data from our current study of CD30 CAR T cells.
Cohorts of three 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: 4 × 10^7 C7R.CD30.CAR-EBVST cells
* Dose Level 2: 1 × 10^8 C7R.CD30.CAR-EBVST cells
* Dose Level 3: 4 × 10^8 C7R.CD30.CAR-EBVST cells
* Dose Level 4: 8 × 10^8 C7R.CD30.CAR-EBVST cells Receives: Biological: C7R.CD30.CAR-EBVST cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity (DLT)
Dose-limiting toxicity (DLT) is defined as any of the following considered possibly, probably, or definitely related to study cellular products: (1) Grade 5 event without disease progression; (2) CRS: Grade 4, or Grade 3 not improving to ≤Grade 2 within 72 hours despite therapy; (3) ICANS: Grade 4, or Grade 3 not improving within 72 hours despite therapy; (4) Grade ≥3 IEC-HS; (5) Grade ≥3 acute GvHD requiring corticosteroids and not resolving within 7 days, or steroid-refractory Grade 2 GvHD; (6) Grade 4 neutropenia or thrombocytopenia not resolving to ≤Grade 2 within 42 days, or Grade 3 thrombocytopenia with major bleeding; (7) Grade ≥3 vital organ toxicity (except transient hepatic/renal abnormalities resolving within 7 days); (8) other Grade 3 toxicities not resolving within 72 hours; (9) Grade ≥2 allergic reaction.
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: 6 to 8 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: 6 to 8 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 posted20 Dec 2023
- Study start27 Oct 2025
- Primary completion27 Jul 2028 (estimated)
- Study completion27 Jun 2043 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CD30-Positive Diffuse Large B-Cell 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
- 90 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
- Premal Lulla, MD, Principal investigator, The Methodist Hospital Research InstituteHelen Heslop, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06176690
- Sponsor's protocol ID
- H-56523, CABAL2
- Acronym
- CABAL2
- Status last verified
- Aug 2026
- First submitted
- 11 Dec 2023
- Last updated
- 2 Oct 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 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Constitutive IL7R (C7R) Modified Banked 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
- NCT06176690
- Acronym / sponsor ID
- CABAL2 / H-56523, CABAL2
- Conditions
- CD30-Positive Diffuse Large B-Cell Lymphoma, Anaplastic Large Cell Lymphoma, T Cell and Null Cell Type, Anaplastic Large Cell Lymphoma, ALK-Positive, Peripheral T-cell Lymphoma, Anaplastic Large Cell Lymphoma, ALK-negative, Non-Hodgkin Lymphoma
- Keywords
- CD30-Positive Lymphoma, Hodgkin lymphoma, non-Hodgkin lymphoma, CD30 CAR
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 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
- 27 Oct 2025 (actual)
- Primary completion
- 27 Jul 2028 (estimated)
- Study completion
- 27 Jun 2043 (estimated)
- First posted
- 20 Dec 2023 (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 involves patients with diffuse large B cell lymphoma (DLBCL), natural killer/T-cell lymphoma (NKTL), or classical Hodgkin lymphoma (cHL) (referred to collectively as lymphoma) whose disease has returned or not responded to treatment.
Previous research combined antibodies and T cells to treat cancer. Antibodies bind to foreign substances, and T cells are infection-fighting white blood cells that can kill tumor cells. Both approaches have shown promise but have not been sufficient to cure most patients. In prior studies, an antibody targeting CD30, a protein found on some T cells and cancer cells, was joined to T cells through gene transfer to create CD30.CAR T cells.
Another study showed encouraging responses using CD30.CAR T cells made from a patient's own blood and returned to the same patient (autologous cells). In an ongoing study, patients have been treated with CD30.CAR T cells derived from healthy donors (allogeneic cells), allowing use of banked cells without individualized manufacturing. This approach has shown promising clinical activity with no safety concerns to date.
In this study, investigators are evaluating CD30.CAR-EBVST cells modified with an additional molecule called C7R, which has been shown in laboratory studies to enhance anti-cancer effects. The study aims to assess the safety and effectiveness of these allogeneic, banked C7R-modified CD30.CAR-EBVST cells and determine whether they may help treat lymphoma.
As an added safety measure, the modified T cells include a marker called iC9. If significant side effects occur, patients may receive rimiducid, which can eliminate the infused T cells. Rimiducid is not yet FDA approved but has been tested in patients without significant side effects.
Detailed description
This is a Phase 1 dose-escalation study evaluating allogeneic C7R.CD30.CAR-EBVST cells in patients with relapsed or refractory CD30-positive lymphoma.
Participants are treated in sequential cohorts at one of four dose levels of C7R.CD30.CAR-EBVST cells. Treatment begins at the lowest dose level, and subsequent cohorts are treated at higher dose levels if the preceding dose is determined to be safe. If significant toxicity is observed, dose escalation may be halted, reduced, or discontinued. The relationship between dose level and both safety and potential clinical benefit is evaluated.
Prior to treatment, participants undergo screening evaluations including laboratory testing, imaging studies, and confirmation of CD30 expression. Human leukocyte antigen (HLA) testing is performed to identify the most appropriate partially matched cell line from a bank of allogeneic C7R.CD30.CAR-EBVST products.
Participants may receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine prior to infusion, as clinically appropriate, to reduce endogenous lymphocytes and support expansion of the infused cells.
C7R.CD30.CAR-EBVST cells are administered as a single intravenous infusion at the assigned dose level. Premedication may be given to reduce the risk of infusion-related reactions. Participants are monitored in the clinical setting following infusion and are required to remain within close proximity to the treatment center for a defined period to allow for monitoring of potential adverse events.
Following treatment, participants undergo scheduled follow-up evaluations including physical examinations, laboratory testing, and imaging studies to assess safety and disease status. Blood samples are collected at multiple time points after infusion to evaluate persistence of the infused cells. Tumor assessments are performed using imaging and, when clinically indicated, biopsy.
Participants demonstrating an objective clinical response following initial dosing may be considered for up to three (3) additional infusions of C7R.CD30.CAR-EBVST cells, at the discretion of the treating clinical team.
Participants are followed longitudinally after treatment, with more frequent assessments early after infusion and less frequent long-term follow-up, for up to 15 years after the most recent infusion.
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: C7R.CD30.CAR-EBVST cellsFour dose levels will be evaluated based on safety data from our current study of CD30 CAR T cells. Cohorts of three 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: 4 × 10^7 C7R.CD30.CAR-EBVST cells * Dose Level 2: 1 × 10^8 C7R.CD30.CAR-EBVST cells * Dose Level 3: 4 × 10^8 C7R.CD30.CAR-EBVST cells * Dose Level 4: 8 × 10^8 C7R.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 (15 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 less than or equal to 2 times the upper limit of normal (except for Gilbert syndrome, where the criteria will be Bilirubin less than or equal to 3 times the upper limit of normal).
- AST less than 3 times the upper limit of normal.
Key exclusion criteria (9 listed)
- Received an investigational cell therapy or vaccine within the past 6 weeks.
- Received an investigational small molecule drug within the past 2 weeks.
- Received anti-CD30 antibody-based therapy within the previous 4 weeks.
- History of hypersensitivity reactions to murine protein-containing products.
- Pregnant or lactating.
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 |
|---|---|---|
| C7R.CD30.CAR-EBVST cellsAlso: Allogeneic CR7.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 4 × 10^8 cells/m2 and we did not reach an MTD. On Day 0, patients will receive their planned 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 (DLT)
Time frame: 28 days
Dose-limiting toxicity (DLT) is defined as any of the following considered possibly, probably, or definitely related to study cellular products: (1) Grade 5 event without disease progression; (2) CRS: Grade 4, or Grade 3 not improving to ≤Grade 2 within 72 hours despite therapy; (3) ICANS: Grade 4, or Grade 3 not improving within 72 hours despite therapy; (4) Grade ≥3 IEC-HS; (5) Grade ≥3 acute GvHD requiring corticosteroids and not resolving within 7 days, or steroid-refractory Grade 2 GvHD; (6) Grade 4 neutropenia or thrombocytopenia not resolving to ≤Grade 2 within 42 days, or Grade 3 thrombocytopenia with major bleeding; (7) Grade ≥3 vital organ toxicity (except transient hepatic/renal abnormalities resolving within 7 days); (8) other Grade 3 toxicities not resolving within 72 hours; (9) Grade ≥2 allergic reaction.
5 secondary outcomes
Rate of Anti-Tumor effect Objective Response (OR)
Time frame: 6 to 8 weeks post CTL infusion
Duration of response
Time frame: Up to 5 years
Stable disease (SD) rate
Time frame: 6 to 8 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
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.
Related trials for CD30-Positive Diffuse Large B-Cell Lymphoma
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DLBCL
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.
Premal Lulla, MD principal investigator
The Methodist Hospital Research Institute
Helen 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 C7R.CD30.CAR-EBVST cells in people with CD30-Positive Diffuse Large B-Cell Lymphoma and Anaplastic Large Cell Lymphoma, T Cell and Null Cell Type, 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 15 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 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?
Contact Premal Lulla, MD (713-441-1450, pdlulla@houstonmethodist.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicity (DLT) (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 2 Oct 2026.