Status:
TERMINATED
A Phase I Study of CD19 Specific T Cells in CD19 Positive Malignancy
Lead Sponsor:
The Christie NHS Foundation Trust
Conditions:
CD19 Positive Non-Hodgkin Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 ...
Detailed Description
CD19 is an Immunoglobulin-like 95kDa glycoprotein that is expressed on all B lymphocytes until differentiation into terminal effector cells (Tedder and Isaacs 1989). It plays an important role in regu...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2019
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01493453
Start Date
March 1 2008
End Date
June 1 2019
Last Update
April 19 2023
Active Locations (1)
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1
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 3EE