Clinical trial · Interventional
A Phase I Study of CD19 Specific T Cells in CD19 Positive Malignancy
A Phase I Study of Adoptive Transfer of Autologous Tumour Antigen-Specific T Cells With Pre-conditioning Chemotherapy and Intravenous IL2 in Patients With CD19 Positive Malignancy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Investigation into serious breach
Summary
Brief summary (as posted)
In particular circumstances T cells can be an effective treatment for malignant disease, for example, donor lymphocyte infusions following allogeneic transplants or treatment of EBV related lymphomas post allograft. However, many common cancers are poorly recognised by the immune system in part because of a lack of suitable T cell targets and in part because of defects in antigen presentation by tumours (Garrido, et al 1997). Genetically modified T cells engineered to express chimeric immune receptors (CIRs) on their cell surface can bypass the need for MHC presentation and thus represent an attractive approach to immunotherapy (Gross, et al 1989).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CD19 Positive Non-Hodgkin Lymphoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aCD19z cells, IL2, pre conditioning Cyclophosphamide & Fludarabine | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Arm - aCD19z cells, interleukin 2, Chemotherapy
- interventionNames
- Genetic: aCD19z cells, IL2, pre conditioning Cyclophosphamide & Fludarabine
Primary outcomes (1)
- measure
- To asses aCD19z T cell survival and aCD19z T cell toxicity in patients, & The dose of aCD19z T cells required to give optimal survival of these cells in the circulation
- timeFrame
- Week 6
Secondary outcomes (1)
- measure
- To assess whether aCD19z T cells in the circulation are functional
- timeFrame
- 6 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have histologically confirmed CD19 positive non-Hodgkin Lymphoma with evidence of persistent or progressive disease and poor prognosis as discussed in detail in section 1.5 * Written informed consent and the ability of the patient to co-operate with study treatment, procedures and follow up must be ensured and documented. * Age equal to or greater than 18 years. * World Health Organisation (WHO) performance status of 0 or 1 (appendix 1). * Life expectancy \>3months. * LVEF \> 50% as measured by MUGA scan * Haematological and biochemical indices: Haemoglobin (Hb)≥ 10.0 g/dl neutrophils ≥ 1.0 x 109/L platelets (Plts)≥ 100 x 109/L Any of the following abnormal baseline liver function tests: serum bilirubin ≤ 1.5 x upper limit of normal (ULN) alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) and /or alkaline phosphatase (ALP)≤ 5 x ULN Serum creatinine ≤ 0.14 mmol/L * Female patients of child-bearing potential are eligible, provided they have a negative serum or urine pregnancy test prior to enrolment and agree to use appropriate medically approved contraceptive precautions for four weeks prior to entering the trial, during the trial, and for six months afterwards. * Male patients must agree to use barrier method contraception during the trial and for six months afterwards. * Measurable disease as defined by RECIST criteria (appendix 3). Exclusion Criteria: * Radiotherapy, biological therapy, endocrine therapy, immunotherapy, systemic steroids, or chemotherapy during the previous four weeks (six weeks for nitrosoureas and Mitomycin-C) prior to treatment or during the course of the trial. * All toxic manifestations of previous treatment must have resolved. Exceptions to this are alopecia or certain Grade 1 toxicities which in the opinion of the Investigator and Trial Sponsor should not exclude the patient. * Participation in any other clinical trial within the previous 30 days or during the course of this trial. * Previous participation in a Gene Therapy trial. * Previous allogeneic transplant. * Patients who are high medical risks because of non-malignant systemic disease, including those with active infection, uncontrolled cardiac or respiratory disease, or other serious medical or psychiatric disorders which in the Investigator's opinion would not make the patient a good candidate for the clinical trial. * Concurrent serious infections within the 28 days prior to entry to the trial. * Current malignancies at other sites, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin. * Patients known or found to be serologically positive for Hepatitis B, C, HIV or HTLV. * History of autoimmune disease. * Evidence of CNS involvement. * Patients who are likely to require systemic steroids or other immunosuppressive therapy. * Pregnant and lactating women. * Radiotherapy to \>25% skeleton.
References
Publications (0)
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