Anti-CCR9 CAR T-cell therapy for T‑cell acute lymphoblastic leukaemia and lymphoblastic lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 trial uses autologous CAR T cells engineered to target CCR9 and modified to resist fratricide. After blood collection, patients receive a short course of lymphodepleting chemotherapy and a single intravenous CAR T-cell infusion, followed by at least two weeks of inpatient monitoring. The study follows a dose-escalation format to identify safety, tolerability, and a recommended dose while monitoring for expected side effects such as cytokine release syndrome and neurologic events. Participants return for approximately a dozen clinic visits over two years with blood tests, bone marrow biopsies and imaging as needed.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* 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:

* 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
* 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

Where it's running

• University College London Hospitals
  London, United Kingdom Recruiting

Study contacts

• Study coordinator: FRACTALL Trial Manager
• Email: ctc.fractall@ucl.ac.uk
• Phone: +44 (0)20 76705748

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• In Vivo CD19/CD20 CAR T-Cell Therapy for Relapsed or Refractory B-Cell Lymphoma

  This early-phase trial tests a one-time in vivo CAR T-cell therapy (SL1617) for people with relapsed or refractory B-cell lymphoma to see if it is safe and tolerable.

  Recruiting Phase 1 Chinese PLA General Hospital · Beijing · NCT07775508

• CD7 CAR T therapy for high-risk T-cell cancers

  This study tests a patient’s own edited T cells, engineered to target CD7, in people with relapsed or high-risk T-cell leukemia or lymphoma.

  Recruiting Phase 1 Baylor College of Medicine · Houston, Texas and 1 other locations · NCT07220993

• CD5 CAR T-cell therapy for relapsed or refractory T-cell lymphoma

  This trial tries CD5 CAR T-cell therapy, using either the patient's own cells or donor cells, and may bridge to stem-cell transplant for people 14–70 with relapsed or refractory T-cell lymphoma.

  Recruiting at 3 sites Phase 1/2 Beijing GoBroad Hospital · Beijing and 2 other locations · NCT07022964

• Glofitamab plus obinutuzumab for mantle cell lymphoma after CAR‑T

  This trial tests whether the antibody drug glofitamab given with obinutuzumab can shrink or control mantle cell lymphoma that returned or didn't respond after CD19 CAR‑T therapy in adults.

  Recruiting at 11 sites Phase 2 National Cancer Institute (NCI) · Duarte, California and 10 other locations · NCT07003295

• CD7 CAR T-Cell Therapy for T-Cell Lymphomas

  This study is testing a new CAR T-cell therapy for people with T-cell lymphomas that haven't responded to regular treatments to see if it is safe and effective.

  Recruiting at 4 sites Phase 1/2 Beijing GoBroad Hospital · Beijing, Beijing Municipality and 3 other locations · NCT06925464

• Using golcadomide and rituximab to prepare patients for CAR T-cell therapy in aggressive B-cell lymphoma

  This study is testing if a combination of golcadomide and rituximab can help patients with aggressive B-cell lymphoma get ready for CAR T-cell therapy.

  Recruiting at 7 sites Phase 2 Mayo Clinic · Scottsdale, Arizona and 6 other locations · NCT06834373

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.