T-cell Acute Lymphoblastic LeukemiaNCT05509855
A Long-Term Safety Follow-Up Study for Patients Treat With WU-CART-007
An observational study of T-cell Acute Lymphoblastic Leukemia and T-cell Lymphoblastic Lymphoma, run by Allotera Therapeutics at 5 sites in 2 countries.
Trial summary
This study will provide long-term follow-up for patients who have received treatment with WU-CART-007 in a previous clinical trial. In this study, patients will be followed for up to 15 years after their last dose of WU-CART-007 for evaluation of delayed adverse events, presence of persisting WU-CART-007 vector… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- T-cell Acute Lymphoblastic Leukemia, T-cell Lymphoblastic Lymphoma
- What is being tested?
- Genetic: WU-CART-007
- How many people
- 44 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 22 Aug 2022to 1 Jul 2037
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The patient population will consist of patients who participated in a previous clinical trial where WU-CART-007 was administered.
Inclusion Criteria: Patients that received WU-CART-007 in the context of any investigational study will be eligible to participate in this long-term follow-up study.
Exclusion Criteria: Not Applicable
Trial locations and contacts
5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 2 countries
United States4 sites
City of Hope
Duarte, California, 91010
Childrens Hospital LA
Los Angeles, California, 90027
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Washington University
St Louis, Missouri, 63110
About this study
Official title: A Long-Term Safety Follow-Up Study for Patients Treated With Anti-CD7 Allogeneic CAR-T Cells (WU-CART-007)
This study will provide long-term follow-up for patients who have received treatment with WU-CART-007 in a previous clinical trial. In this study, patients will be followed for up to 15 years after their last dose of WU-CART-007 for evaluation of delayed adverse events, presence of persisting WU-CART-007 vector sequences, and overall survival and progression-free survival.
Read the detailed description
This long-term follow-up (LTFU) study is designed to follow patients for up to 15 years after WU-CART-007 infusion to evaluate the persistence of the WU-CART-007 cell clones and to explore any unanticipated genetic consequences secondary to the introduction of genetically modified cells. Long-term toxicity, subsequent anti-cancer therapy, and survival status will be monitored.
Patients will transition to this LTFU study when they meet the criteria for discontinuation from the main study or after completing 24 months of follow-up in the main study. Patients will be contacted every 6 months for the first 5 years following WU-CART-007 administration and then yearly, for up to 10 years, for a total of 15 years of follow-up after prior WU-CART-007 treatment or until death, whichever occurs first.
Patients will be evaluated either at the treating site or by the patient's primary Health Care Provider (HCP). Patients will be required to allow key sponsor contacts to continue to access medical records so that information related to their health condition and initial treatment response may be obtained.
- Being tested
- Genetic: WU-CART-007
- Keywords
- T-ALL, T-LBL
- Medical subject headings
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetic: WU-CART-007Genetic
No study drug is administered in this study. Patients who have received WU-CART-007 will be enrolled in this study for Long Term Safety and Efficacy
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with WU-CART-007 | Patients who received previous treatment with WU-CART-007 Receives: Genetic: Genetic: WU-CART-007 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delayed adverse events (AEs)/serious adverse events (SAEs)
assess the risk of delayed adverse events including serious events following exposure to WU-CART-007
Measured: up to 15 years
Persistence of WU-CART-007 cells
Peripheral blood samples will be monitored used polymerase chain reaction for persistence of WU-CART-007 cells
Measured: Every 6 months for up to 5 years and then yearly for up to 15 years
Tanner Staging
Tanner Staging will be used to evaluate growth and development outcomes and sexual maturity status for patients who were < 18 years of age at the time of treatment with WU CART-007
Measured: up to 15 years
Secondary outcomes (2)
Overall survival (OS)
To evaluate survival n patients previously treated with WU-CART-007
Measured: up to 15 years
Progression-free survival (PFS)
To evaluate profession free survival in patients previously treated with WU-CART-007
Measured: up to 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start22 Aug 2022
- Primary completion1 Jul 2037 (estimated)
- Study completion1 Jul 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T-cell Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Allotera Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cherry Thomas, MD, Study director, Allotera Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05509855
- Sponsor's protocol ID
- WUC007-02
- Status last verified
- Sep 2024
- First submitted
- 20 Jul 2022
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-Term Safety Follow-Up Study for Patients Treated With Anti-CD7 Allogeneic CAR-T Cells (WU-CART-007)
- ClinicalTrials.gov ID
- NCT05509855
- Acronym / sponsor ID
- WUC007-02
- Keywords
- T-ALL, T-LBL
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Allotera TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 22 Aug 2022 (actual)
- Primary completion
- 1 Jul 2037 (estimated)
- Study completion
- 1 Jul 2037 (estimated)
- First posted
- 22 Aug 2022 (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 will provide long-term follow-up for patients who have received treatment with WU-CART-007 in a previous clinical trial. In this study, patients will be followed for up to 15 years after their last dose of WU-CART-007 for evaluation of delayed adverse events, presence of persisting WU-CART-007 vector sequences, and overall survival and progression-free survival.
Detailed description
This long-term follow-up (LTFU) study is designed to follow patients for up to 15 years after WU-CART-007 infusion to evaluate the persistence of the WU-CART-007 cell clones and to explore any unanticipated genetic consequences secondary to the introduction of genetically modified cells. Long-term toxicity, subsequent anti-cancer therapy, and survival status will be monitored.
Patients will transition to this LTFU study when they meet the criteria for discontinuation from the main study or after completing 24 months of follow-up in the main study. Patients will be contacted every 6 months for the first 5 years following WU-CART-007 administration and then yearly, for up to 10 years, for a total of 15 years of follow-up after prior WU-CART-007 treatment or until death, whichever occurs first.
Patients will be evaluated either at the treating site or by the patient's primary Health Care Provider (HCP). Patients will be required to allow key sponsor contacts to continue to access medical records so that information related to their health condition and initial treatment response may be obtained.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated with WU-CART-007 | – | Genetic: Genetic: WU-CART-007Patients who received previous treatment with WU-CART-007 |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patient population will consist of patients who participated in a previous clinical trial where WU-CART-007 was administered.
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 |
|---|---|---|
| Genetic: WU-CART-007No study drug is administered in this study. Patients who have received WU-CART-007 will be enrolled in this study for Long Term Safety and Efficacy | Genetic | Patients treated with WU-CART-007 |
Primary outcome
Delayed adverse events (AEs)/serious adverse events (SAEs)
Time frame: up to 15 years
assess the risk of delayed adverse events including serious events following exposure to WU-CART-007
Persistence of WU-CART-007 cells
Time frame: Every 6 months for up to 5 years and then yearly for up to 15 years
Peripheral blood samples will be monitored used polymerase chain reaction for persistence of WU-CART-007 cells
Tanner Staging
Time frame: up to 15 years
Tanner Staging will be used to evaluate growth and development outcomes and sexual maturity status for patients who were < 18 years of age at the time of treatment with WU CART-007
2 secondary outcomes
Overall survival (OS)
Time frame: up to 15 years
Progression-free survival (PFS)
Time frame: up to 15 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 20 Nov 2024.
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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.
Cherry Thomas, MD study director
Allotera Therapeutics
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of T-cell Acute Lymphoblastic Leukemia and T-cell Lymphoblastic Lymphoma, run by Allotera Therapeutics at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: enrolling by invitation, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Australia. 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?
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?
Delayed adverse events (AEs)/serious adverse events (SAEs) (time frame: up to 15 years). The study lists 3 primary outcomes in all. 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 20 Nov 2024.