Hodgkin Lymphoma, AdultNCT03914885
Compassionate Use Re-Infusion of ATLCAR.CD30
A study testing ATLCAR.CD30, Bendamustine and Fludarabine in people with Hodgkin Lymphoma, Adult, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
This protocol for compassionate use combines 2 different ways of fighting disease: antibodies and T cells. Both antibodies and T cells have been used to treat patients with cancers, and both have shown promise, but neither alone has been sufficient to cure most patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hodgkin Lymphoma, Adult
- What is being tested?
- ATLCAR.CD30, Bendamustine and Fludarabine
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Karnofsky or Lansky score of >60%.
- WOCBP must be willing to use 2 methods of birth control or be surgically sterile , or abstain from heterosexual activity for the course of the study, or for 6 months after the study is concluded. WOCBP are those who have not been surgically sterilized or have not been free from menses for > 1 year. The two birth control methods can be composed of: two barrier methods or a barrier method plus a hormonal method to prevent pregnancy. WOCBP subjects will also be instructed to tell their male partners to use a condom.
- Must not be pregnant or lactating.
- Must not have tumor in a location where enlargement could cause airway obstruction.
- Must not have current use of systemic corticosteroids at doses ≥10 mg prednisone daily or its equivalent; those receiving <10mg daily may be enrolled at discretion of the Investigator
- Evidence of adequate organ function as defined by:
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- ANC>1.0 × 109/L
- Platelets >75 × 109/L
- Total bilirubin ≤2 × ULN, unless attributed to Gilbert's syndrome
- AST ≤3 × ULN
- Serum creatinine ≤1.5 × ULN
- Pulse oximetry of >90% on room air Note: Patient may receive a second infusion without prior lymphodepletion if they meet the eligibility criteria in this Sections 3.1 and 3.2 at the time of infusion, but do not meet the eligibility requirements for adequate bone marrow function and platelet counts
- Negative serum pregnancy test within 72 hours prior to lymphodepletion or documentation that the patient is post-menopausal. Post-menopausal status must be confirmed with documentation of absence of menses for > 1 year or documentation of surgical menopause involving bilateral oophorectomy.
- Patient cannot be on strong inhibitors of CYP1A2 (e.g., fluvoxamine, ciprofloxacin) as these may increase plasma concentrations of bendamustine, and decrease plasma concentrations of its metabolites. See http://medicine.iupui.edu/clinpharm/ddis/ for an updated list of strong inhibitors of CYP1A2. (This applies to subjects who receive bendamustine for lymphodepletion (required) up through 72 hours after the last dose of bendamustine)
- Patient is a good candidate for treatment with ATLCAR.CD30 per the investigator's discretion.
Who cannot join
- No evidence of uncontrolled infection or sepsis.
- Evidence of adequate organ function as defined by:
- Total bilirubin ≤2 × ULN, unless attributed to Gilbert's syndrome
- AST ≤3 × ULN
- ALT ≤3 × ULN
- Serum creatinine ≤1.5 × ULN
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- Pulse oximetry of >90% on room air
- Patient has no clinical indication of rapidly progressing disease in the opinion of the treating physician
- Patient is a good candidate for treatment with ATLCAR.CD30 per the investigator's discretion.
- If Patient has had positive hepatitis B core antibody testing while on the LCCC 1532-ATL clinical trial, they must not have had re-activation of the Hepatitis B virus since baseline testing (i.e., they will be excluded if any of their hepatitis B viral load testing is positive up until the point of eligibility determination for re-infusion).
Trial locations and contacts
1 site in 1 country.
United States1 site
Lineberger Comprehensive Cancer Center at University of North Carolina
Chapel Hill, North Carolina, 27599
About this study
This protocol for compassionate use combines 2 different ways of fighting disease: antibodies and T cells. Both antibodies and T cells have been used to treat patients with cancers, and both have shown promise, but neither alone has been sufficient to cure most patients. This protocol combines both T cells and antibodies to create a more effective treatment. The investigational treatment is called autologous T lymphocyte chimeric antigen receptor cells targeted against the CD30 antigen (ATLCAR.CD30) administration.
Prior studies have shown that a new gene can be put into T cells and will increase their ability to recognize and kill cancer cells. The new gene that is put in the T cells in this study makes a piece of an antibody called anti-CD30. This antibody sticks to leukemia cells because they have a substance on the outside of the cells called CD30. For this protocol, the anti-CD30 antibody has been changed so that instead of floating free in the blood part of 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 CD30 chimeric (combination) receptor-activated T cells seem to kill some of the tumor, but they do not last very long in the body and so their chances of fighting the cancer are unknown.
The primary purpose of this protocol is to treat a single patient with a second dose of ATLCAR.CD30 T cells.
Read the detailed description
Lymphodepleting Chemotherapy:
The patient will receive a lymphodepleting regimen of bendamustine 70mg/m2/day over 3 consecutive days and fludarabine 30mg/m2/day over 2 consecutive days. Bendamustine and fludarabine will be administered concomitantly. Dose reduction of bendamustine may occur per treating physician discretion based on prior toxicities and the clinical status of the patient.
Administration of ATLCAR.CD30 T cells:
Post lymphodepletion, if the patient meets eligibility criteria for cellular therapy, then will receive ATLCAR.CD30 T cells within 2-14 days after completing the pre-conditioning chemotherapy regimen. We will administer ATLCAR.CD30 T cells post lymphodepletion at a dose of 2 x 10^8 cells/m2.
Duration of Therapy:
Therapy under this compassionate use protocol involves 1 infusion of ATLCAR.CD30 cells.
Duration of Follow-up:
The patient will be followed for up to 15 years for replication-competent retrovirus evaluation or until death, whichever occurs first.
- Conditions
- Hodgkin Lymphoma, Adult
- Being tested
- ATLCAR.CD30, Bendamustine, Fludarabine
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATLCAR.CD30Genetic
Also called CD30 CAR T cells
Administered at a dose of 2 x 10^8 cells/m2
BendamustineDrug
Also called Bendeka, Treanda
Administered as a dose of 70mg/m2/day over 3 consecutive days; maybe dose reduced per treating physician discretion based on prior toxicities and the patient's clinical status
FludarabineDrug
Also called Fludara
Administered at a dose of 30mg/m2/day over 3 consecutive days; given concomitantly with bendamustine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin Lymphoma, AdultStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Natalie Grover, MD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03914885
- Sponsor's protocol ID
- LCCC1907-ATL-COM
- Status last verified
- Dec 2019
- First submitted
- 10 Apr 2019
- Last updated
- 3 Dec 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compassionate Use Re-Infusion of ATLCAR.CD30
- ClinicalTrials.gov ID
- NCT03914885
- Acronym / sponsor ID
- LCCC1907-ATL-COM
- Conditions
- Hodgkin Lymphoma, Adult
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- First posted
- 16 Apr 2019 (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 protocol for compassionate use combines 2 different ways of fighting disease: antibodies and T cells. Both antibodies and T cells have been used to treat patients with cancers, and both have shown promise, but neither alone has been sufficient to cure most patients. This protocol combines both T cells and antibodies to create a more effective treatment. The investigational treatment is called autologous T lymphocyte chimeric antigen receptor cells targeted against the CD30 antigen (ATLCAR.CD30) administration.
Prior studies have shown that a new gene can be put into T cells and will increase their ability to recognize and kill cancer cells. The new gene that is put in the T cells in this study makes a piece of an antibody called anti-CD30. This antibody sticks to leukemia cells because they have a substance on the outside of the cells called CD30. For this protocol, the anti-CD30 antibody has been changed so that instead of floating free in the blood part of 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 CD30 chimeric (combination) receptor-activated T cells seem to kill some of the tumor, but they do not last very long in the body and so their chances of fighting the cancer are unknown.
The primary purpose of this protocol is to treat a single patient with a second dose of ATLCAR.CD30 T cells.
Detailed description
Lymphodepleting Chemotherapy:
The patient will receive a lymphodepleting regimen of bendamustine 70mg/m2/day over 3 consecutive days and fludarabine 30mg/m2/day over 2 consecutive days. Bendamustine and fludarabine will be administered concomitantly. Dose reduction of bendamustine may occur per treating physician discretion based on prior toxicities and the clinical status of the patient.
Administration of ATLCAR.CD30 T cells:
Post lymphodepletion, if the patient meets eligibility criteria for cellular therapy, then will receive ATLCAR.CD30 T cells within 2-14 days after completing the pre-conditioning chemotherapy regimen. We will administer ATLCAR.CD30 T cells post lymphodepletion at a dose of 2 x 10^8 cells/m2.
Duration of Therapy:
Therapy under this compassionate use protocol involves 1 infusion of ATLCAR.CD30 cells.
Duration of Follow-up:
The patient will be followed for up to 15 years for replication-competent retrovirus evaluation or until death, whichever occurs first.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Karnofsky or Lansky score of >60%.
- WOCBP must be willing to use 2 methods of birth control or be surgically sterile , or abstain from heterosexual activity for the course of the study, or for 6 months after the study is concluded. WOCBP are those who have not been surgically sterilized or have not been free from menses for > 1 year. The two birth control methods can be composed of: two barrier methods or a barrier method plus a hormonal method to prevent pregnancy. WOCBP subjects will also be instructed to tell their male partners to use a condom.
- Must not be pregnant or lactating.
- Must not have tumor in a location where enlargement could cause airway obstruction.
- Must not have current use of systemic corticosteroids at doses ≥10 mg prednisone daily or its equivalent; those receiving <10mg daily may be enrolled at discretion of the Investigator
Key exclusion criteria (10 listed)
- No evidence of uncontrolled infection or sepsis.
- Evidence of adequate organ function as defined by:
- Patient has no clinical indication of rapidly progressing disease in the opinion of the treating physician
- Patient is a good candidate for treatment with ATLCAR.CD30 per the investigator's discretion.
- If Patient has had positive hepatitis B core antibody testing while on the LCCC 1532-ATL clinical trial, they must not have had re-activation of the Hepatitis B virus since baseline testing (i.e., they will be excluded if any of their hepatitis B viral load testing is positive up until the point of eligibility determination for re-infusion).
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 |
|---|---|---|
| ATLCAR.CD30Also: CD30 CAR T cellsAdministered at a dose of 2 x 10^8 cells/m2 | Genetic | – |
| BendamustineAlso: Bendeka, TreandaAdministered as a dose of 70mg/m2/day over 3 consecutive days; maybe dose reduced per treating physician discretion based on prior toxicities and the patient's clinical status | Drug | – |
| FludarabineAlso: FludaraAdministered at a dose of 30mg/m2/day over 3 consecutive days; given concomitantly with bendamustine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2021.
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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.
Natalie Grover, MD principal investigator
UNC Lineberger Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ATLCAR.CD30, Bendamustine and Fludarabine in people with Hodgkin Lymphoma, Adult, run by UNC Lineberger Comprehensive Cancer Center at 1 site 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 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: status not confirmed, as of the sponsor's last update on 3 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Results are not available in the source record.
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.
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 3 Dec 2021; AzTrials last refreshed its copy on 7 Nov 2026.