We'd like your feedback
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Alka
Lal
Alka.Lal@cancer.org.uk
Emma
Ingleson
aleta@cancer.org.uk
Sridhar
Chaganti
sridhar.chaganti@uhb.nhs.uk
Alka
Lal
Alka.Lal@cancer.org.uk
Malignant neoplasms, stated or presumed to be primary, of lymphoid, haematopoietic and related tissue
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
ALETA-001 is a type of drug called a T cell engager. T cell engagers aim to boost the activity of specific T cells in the body. It has been tested in animals and in the laboratory and looks promising in treating certain cancers. We want to find out if it will be useful in treating patients with Non Hodgkin’s lymphoma,after they have received a type of CAR T cell therapy called anti-CD19 CAR T cell therapy.
Not all patients’ cancer will have gone away after CAR T cell therapy. ALETA-001 has been designed to help the CAR T cells work better and kill the cancer cells for those patients. In this trial ALETA-001 will be offered to these patients,and will allow us to check how safe and effective it is.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Interventional type: Drug;
You can take part if:
You may not be able to take part if:
1) Concurrent radiotherapy (except for palliative reasons). 2) Potential participants who experienced any of the following because of the initial CAR T treatment - Grade 4 ICANs - Grade ≥3 ICANs persisting beyond 7 days and despite optimal supportive therapy - Grade 4 CRS - Grade 3 CRS persisting beyond 7 days and despite optimal supportive therapy - Any Grade 2 ICANs or CRS must be fully resolved 3) Any ongoing toxic manifestation of previous anti cancer treatment that in the opinion of the Investigator should exclude the participant. 4) Active or previous malignancies of other types that in the opinion of the Investigator should exclude the participant. Current malignancies of other types except for adequately treated cone biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin. Cancer survivors who have undergone potentially curative therapy for a prior malignancy and have no evidence of that disease for 2 years or more and are deemed at negligible risk for recurrence,are eligible for the trial. Participants with asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy or who require only hormonal therapy and have had normal prostate specific antigen (PSA) for >1 year prior to the start of therapy are eligible for participation in the trial. 5) Ongoing need for systemic immunosuppressive therapy other than replacement dose of corticosteroids. Note that intermittent topical,inhaled or intra nasal corticosteroids are permitted. 6) Presence of active infections and/ or inflammatory disease requiring active management. 7) Documented current central nervous system (CNS) involvement by lymphoma. 8) Women of childbearing potential (or are already pregnant or lactating). However,those participants who meet the following points are considered eligible: • Have a negative pregnancy test (highly sensitive serum OR urine test) within 7 days before enrolment,and • Agree to use one form of highly effective contraception such as: i. oral,intravaginal,or transdermal combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation ii. oral,injectable,or implantable progestogen only hormonal contraception associated with inhibition of ovulation iii. intrauterine device iv. intrauterine hormone releasing system v. bilateral tubal occlusion vi. vasectomised partner,plus,a barrier method (e.g.,condom),• or agree to sexual abstinence. Effective from the first administration of ALETA 001,throughout the trial and for 12 months after the last administration of ALETA 001. 9) Male participants with partners of childbearing potential. However,those participants who meet the following points are considered eligible: • Agree to take measures not to father children by using a barrier method of contraception (condom plus spermicide) or sexual abstinence,effective from the first administration of ALETA 001,throughout the trial and for 6 months after the last administration of ALETA 001. • To prevent exposure of the foetus or neonate to ALETA-001,male participants with pregnant or lactating partners must agree to use barrier method contraception (e.g.,condom). • Non vasectomised male participants must also be willing to ensure that any partner of childbearing potential uses a highly effective method of contraception (e.g.,oral,injected,implanted,transdermal or intravaginal hormonal contraception associated with inhibition of ovulation,intrauterine device,intrauterine hormone releasing system,or bilateral tubal occlusion) or agree to sexual abstinence for the same duration. 10) Major thoracic or abdominal surgery from which the participant has not yet recovered. 11) At high medical risk because of non malignant systemic disease including active uncontrolled infection. 12) Hypersensitivity to any of the ingredients/excipients in ALETA 001 13) Participation in another interventional clinical trial,whilst taking part in this trial of ALETA 001. Participation in an observational trial or interventional clinical trial that does not involve administration of an IMP and that would not place an unacceptable burden on the participant,in the opinion of the Investigator and CDD,would be acceptable. 14) Participants with any congenital or acquired immunodeficiency syndrome or who are receiving immunosuppressive therapy (including any dose of systemic corticosteroids),or who are immunosuppressed post organ transplant. However,participants receiving inhaled corticosteroids and participants with a history of allergy (other than anaphylaxis) are eligible,as are participants with a history of autoimmune disease. 15) Any other condition that,in the Investigator’s opinion,would mean that the trial is not in the best interests of the participant.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Sridhar
Chaganti
sridhar.chaganti@uhb.nhs.uk
Emma
Ingleson
aleta@cancer.org.uk
Alka
Lal
Alka.Lal@cancer.org.uk
Alka
Lal
Alka.Lal@cancer.org.uk
The study is sponsored by CANCER RESEARCH UK and funded by CANCER RESEARCH UK .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 55637
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
