T Cell Acute Lymphoblastic LeukemiaPhase 1FRACTALLNCT07300683
Anti-CCR9 CAR T Cells for T Cell Leukaemia/Lymphoma
A Phase 1 study testing CARCCR9 T cells in people with T Cell Acute Lymphoblastic Leukemia and T Cell Lymphoblastic Lymphoma, run by University College, London at 1 site in United Kingdom.
Trial summary
The goal of this clinical trial is to learn if anti-CCR9 CAR T cells (which will be made using the patient's own blood cells) are safe and which dose should be used in children and adults with T cell leukaemia and lymphoma. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- T Cell Acute Lymphoblastic Leukemia, T Cell Lymphoblastic Lymphoma
- What is being tested?
- CARCCR9 T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Nov 2025to Dec 2042
- 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
- Relapsed or refractory T-ALL/T-LBL following at least one (≥18 years old) or two (<18 years old) standard prior lines of combination cytotoxic therapy
- CCR9-positive disease as assessed by flow cytometry
- T-LBL patients only: Patients must have measurable disease
- Agreement to have a pregnancy test, use adequate contraception (if applicable)
- Written informed consent
Who cannot join
- ECOG performance score >2 (patients aged ≥10 years old) OR Lanksy score ≤50% (patients aged <10 years old)
- Stem Cell Transplant patients only: active significant acute GvHD or moderate/severe chronic GvHD requiring immunosuppressive therapy and/or systemic steroids
- Active CNS involvement of disease
- Active hepatitis B, C or HIV infection
- Oxygen saturation ≤90% on air
- Bilirubin >3 x upper limit of normal
Show all 14Show fewer
- GFR <30 ml/min
- Cardiac dysfunction
- Patients receiving corticosteroids at a supraphysiological dose that cannot be discontinued
- Known allergy to any component of the ATIMP
- Any contraindications to lymphodepletion or to the use of cyclophosphamide or fludarabine as per local SmPC
- Women who are pregnant or breastfeeding
- Life expectancy <3 months
- Fulminant or rapidly progressive disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University College London Hospitals
London
About this study
Official title: Fratricide-Resistant Autologous Chimeric Antigen Receptor T Cells Targeting CCR9 for the Treatment of T Cell Acute Lymphoblastic Leukaemia/ Lymphoma
The goal of this clinical trial is to learn if anti-CCR9 CAR T cells (which will be made using the patient's own blood cells) are safe and which dose should be used in children and adults with T cell leukaemia and lymphoma.
Participants will:
- have T cells collected from their blood and these T cells will be used to make the CAR-T cells in a specialized laboratory.
- be admitted at the hospital a week before the CAR T cells infusion to receive a short course of chemotherapy drugs which prepare the body to receive the CAR T cells.
- be given the CAR T cells into their vein.
- stay in the hospital for a minimum of 2 weeks to be closely monitored
- following discharge, participants will come to the clinic for check-ups (approximately 12 visits in the first two years)
- during screening, treatment and follow up visits, participants will have physical examination, collection of blood samples and bone marrow biopsies and/or imaging tests (CT/PET-CT scans) depending on their type of T-cell cancer.
- Being tested
- CARCCR9 T cells
- Keywords
- FRACTALL, Fratricide-Resistant, CCR9, CAR T cells
- 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.
CARCCR9 T cellsBiological
Anti-CCR9 CAR T cells
| Study group | Role | What they receive |
|---|---|---|
| Autologous anti-CCR9 CAR T cells | Experimental | Patients will receive autologous anti-CCR9 CAR T cells intravenously. Receives: Biological: CARCCR9 T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of generation of CARCCR9 T cells as evaluated by the number of therapeutic products generated.
To determine the feasibility of semi-automated autologous CARCCR9 T cells manufacture in patients with r/r T-ALL/T-LBL, in the setting of a Phase I trial.
Measured: 2 years
Incidence of treatment-related adverse events (safety and tolerability)
Incidence of grade 3-5 toxicity causally related to the ATIMP.
Measured: From CAR T cells infusion until 28 days post infusion
Secondary outcomes (7)
Persistence of CARCCR9 T cells
Persistence of circulating CARCCR9 T cells in peripheral blood
Measured: From CAR T cells infusion until 2 years post infusion
Expansion of CARCCR9 T cells
Frequency of circulating CARCCR9 T cells in peripheral blood
Measured: From CAR T cells infusion until 2 years post infusion
Potential efficacy of CARCCR9 T cells
Proportion of responders
Measured: At 1 and 2 years post CAR T cells infusion
Potential efficacy of CARCCR9 T cells
Depth of response
Measured: At 1 and 2 years post CAR T cells infusion
Time to disease progression
Length of time from CAR T cells infusion until disease progression
Measured: From CAR T cells infusion (Day 0) until the date of first documented progression, assessed up to 15 years post CAR T cells infusion.
Event free survival
Length of time after a patient receives the CAR T cells and remain free from disease progression, recurrence, or death from any cause.
Measured: From CAR T cells infusion (Day 0) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 15 years post CAR T cells infusion.
Overall survival
Length of time from the CAR T cells infusion until death, regardless of the cause
Measured: From CAR T cells infusion (Day 0) until the date of death from any cause, assessed up to 15 years post CAR T cells infusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start11 Nov 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2042 (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.
- More trials run by University College, LondonThe 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
- Model description
- This is a multi-centre, non-randomised, open-label Phase I clinical trial of an Advanced Therapy Investigational Medicinal Product (ATIMP) for patients with high-risk, relapsed/refractory (r/r) T-ALL/T-LBL. The trial will have 2 cohorts: Adult (≥18 years old) and Paediatric (\<18 years old).
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Great Ormond Street Hospital Charity, Medical Research Council
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07300683
- Sponsor's protocol ID
- UCL/150854
- Other IDs
- 2022-003497-23, ISRCTN15341827
- Acronym
- FRACTALL
- Status last verified
- Nov 2025
- First submitted
- 15 Sep 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fratricide-Resistant Autologous Chimeric Antigen Receptor T Cells Targeting CCR9 for the Treatment of T Cell Acute Lymphoblastic Leukaemia/ Lymphoma
- ClinicalTrials.gov ID
- NCT07300683
- Acronym / sponsor ID
- FRACTALL / UCL/150854
- Keywords
- FRACTALL, Fratricide-Resistant, CCR9, CAR T cells
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Great Ormond Street Hospital Charity, Medical Research Council
- Study start
- 11 Nov 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2042 (estimated)
- First posted
- 24 Dec 2025 (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.
The goal of this clinical trial is to learn if anti-CCR9 CAR T cells (which will be made using the patient's own blood cells) are safe and which dose should be used in children and adults with T cell leukaemia and lymphoma.
Participants will:
- have T cells collected from their blood and these T cells will be used to make the CAR-T cells in a specialized laboratory.
- be admitted at the hospital a week before the CAR T cells infusion to receive a short course of chemotherapy drugs which prepare the body to receive the CAR T cells.
- be given the CAR T cells into their vein.
- stay in the hospital for a minimum of 2 weeks to be closely monitored
- following discharge, participants will come to the clinic for check-ups (approximately 12 visits in the first two years)
- during screening, treatment and follow up visits, participants will have physical examination, collection of blood samples and bone marrow biopsies and/or imaging tests (CT/PET-CT scans) depending on their type of T-cell cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a multi-centre, non-randomised, open-label Phase I clinical trial of an Advanced Therapy Investigational Medicinal Product (ATIMP) for patients with high-risk, relapsed/refractory (r/r) T-ALL/T-LBL. The trial will have 2 cohorts: Adult (≥18 years old) and Paediatric (<18 years old).
| Arm | Type | Receives |
|---|---|---|
| Autologous anti-CCR9 CAR T cells | Experimental | Biological: CARCCR9 T cellsPatients will receive autologous anti-CCR9 CAR T cells intravenously. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Relapsed or refractory T-ALL/T-LBL following at least one (≥18 years old) or two (<18 years old) standard prior lines of combination cytotoxic therapy
- CCR9-positive disease as assessed by flow cytometry
- T-LBL patients only: Patients must have measurable disease
- Agreement to have a pregnancy test, use adequate contraception (if applicable)
- Written informed consent
Key exclusion criteria (14 listed)
- ECOG performance score >2 (patients aged ≥10 years old) OR Lanksy score ≤50% (patients aged <10 years old)
- Stem Cell Transplant patients only: active significant acute GvHD or moderate/severe chronic GvHD requiring immunosuppressive therapy and/or systemic steroids
- Active CNS involvement of disease
- Active hepatitis B, C or HIV infection
- Oxygen saturation ≤90% on air
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 |
|---|---|---|
| CARCCR9 T cellsAnti-CCR9 CAR T cells | Biological | Autologous anti-CCR9 CAR T cells |
Primary outcome
Feasibility of generation of CARCCR9 T cells as evaluated by the number of therapeutic products generated.
Time frame: 2 years
To determine the feasibility of semi-automated autologous CARCCR9 T cells manufacture in patients with r/r T-ALL/T-LBL, in the setting of a Phase I trial.
Incidence of treatment-related adverse events (safety and tolerability)
Time frame: From CAR T cells infusion until 28 days post infusion
Incidence of grade 3-5 toxicity causally related to the ATIMP.
7 secondary outcomes
Persistence of CARCCR9 T cells
Time frame: From CAR T cells infusion until 2 years post infusion
Expansion of CARCCR9 T cells
Time frame: From CAR T cells infusion until 2 years post infusion
Potential efficacy of CARCCR9 T cells
Time frame: At 1 and 2 years post CAR T cells infusion
Potential efficacy of CARCCR9 T cells
Time frame: At 1 and 2 years post CAR T cells infusion
Time to disease progression
Time frame: From CAR T cells infusion (Day 0) until the date of first documented progression, assessed up to 15 years post CAR T cells infusion.
Event free survival
Time frame: From CAR T cells infusion (Day 0) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 15 years post CAR T cells infusion.
Overall survival
Time frame: From CAR T cells infusion (Day 0) until the date of death from any cause, assessed up to 15 years post CAR T cells infusion.
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 24 Dec 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CARCCR9 T cells in people with T Cell Acute Lymphoblastic Leukemia and T Cell Lymphoblastic Lymphoma, run by University College, London at 1 site in United Kingdom.
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 5 inclusion and 14 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 24 Dec 2025. 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 Kingdom. 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 FRACTALL Trial Manager (+44 (0)20 76705748, ctc.fractall@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of generation of CARCCR9 T cells as evaluated by the number of therapeutic products generated. (time frame: 2 years). The study lists 2 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 24 Dec 2025.