CAR T cells to fight T cell leukaemia

Phase 1

• Conditions: Relapsed/refractory T-cell acute lymphoid leukaemia; Cancer

• Registration Number: ISRCTN15323014
• Lead Sponsor: Great Ormond Street Hospital

Brief Summary

2023 Interim results article in https://pubmed.ncbi.nlm.nih.gov/37314354/ (added 15/06/2023)

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-06
• Last Update Posted: 29 April 2024
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Demographic characteristics:
1. Male or female patients
2. Age ranging between 6 months and <16 years

Medical and therapeutic criteria:
1. Relapsed/refractory T cell malignancy ahead of planned allogeneic haematopoietic stem cell transplantation (allo-SCT). Morphologically confirmed with leukemic blasts in the bone marrow (>5%) or a quantifiable MRD load (by multiparameter flow cytometry and/or quantitative polymerase chain reaction)
2. CD7+ (>99%) leukaemia associated immunophenotype (LAIP)
3. Eligible and fit for allogeneic hematopoietic stem cells transplantation with suitable donor available
4. Estimated life expectancy =12 weeks
5. Lansky (age <16 years at the time of assent/consent) or Karnofsky (age =16 years at the time of assent/consent) performance status =70; Eastern Cooperative Oncology Group ECOG performance status < 2

Exclusion Criteria

1. Patients/parents unwilling to undergo a follow-up for 15 years
2. Foreseeable poor compliance to the study procedures
3. Evidence of disease progression after cytoreduction
4. Uncontrollable CNS leukaemia or neurological symptoms defined as CNS grade 3 (per National Comprehensive Cancer Network guidelines)
5. Absence of suitable HLA matched or mismatched donor
6. Weight <6 kg
7. Presence of donor-specific anti-HLA antibodies directed against BE-CAR7
8. GvHD requiring systemic therapy
9. Systemic steroid therapy prednisolone >0.5 mg/kg/day
10. Known hypersensitivity to any of the test materials or related compounds
11. Active bacterial, fungal or viral infection not controlled by standard of care anti-microbial or anti-viral treatment. Uncontrolled bacteraemia/ fungaemia is defined as the ongoing detection of bacteria/fungus on blood cultures despite antibiotic or antifungal therapy. Uncontrolled viraemia is defined as rising viral loads on two consecutive occasions despite antiviral therapy.
12. Risk of pregnancy or non-compliance with contraception (if applicable). Girls of childbearing potential must have been tested negative in a pregnancy test within 14 days prior to inclusion.
13. Lactating female participants unwilling to stop breastfeeding
14. Prior CAR therapy known to be associated with =Grade 3 cytokine release syndrome (CRS) or =Grade 3 drug-related CNS toxicity

Study & Design

• Study Type: Interventional
• Study Design: Not specified