Phase 1 Lymphoma Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

For people with B-cell acute lymphoblastic leukaemia (B-ALL):

• People who have a confirmed diagnosis of B-ALL that has come back or stopped responding to treatment, and whose cancer cells carry a protein called CD19 on their surface.

For people with certain types of non-Hodgkin lymphoma (NHL) or a related condition called CLL/SLL:

• People with an aggressive form of CD19-positive B-cell lymphoma that has come back or stopped responding to treatment, confirmed by a tissue sample taken after the most recent relapse following CD19-targeted therapy.
• Depending on the part of the trial, eligible lymphoma types may include diffuse large B-cell lymphoma (DLBCL), follicular lymphoma, high-grade B-cell lymphoma, primary mediastinal lymphoma, marginal zone lymphoma, Waldenstrom's macroglobulinemia, CLL/SLL, primary CNS lymphoma, and certain related subtypes (confirm specific subtype eligibility with the trial site).
• For one group (CAR T-relapsed): People whose cancer initially responded to a previous CD19-targeted CAR T-cell therapy but then came back, and who have had no more than 2 further lines of treatment since that CAR T therapy.
• For another group (CAR T-naive): People who have had at least 1–2 prior treatment courses (depending on cancer type) but no more than 7 prior systemic anti-cancer treatments.

For all participants across all groups:

• People who are generally well enough to carry out light activity and care for themselves, as measured by a standard health scale (a score of 0 or 1 on the ECOG scale).
• People whose doctor estimates they have a life expectancy of at least 12 weeks.
• People who test negative for HIV.
• People whose bone marrow, kidneys, liver, lungs, and heart are all functioning at an adequate level.

Who may not be able to join:

For people with B-ALL specifically:

• People whose leukaemia is a specific subtype called Burkitt cell (L3 ALL) or mixed-lineage acute leukaemia.

For people with NHL specifically:

• People who urgently need treatment because the tumour is physically blocking something, such as the bowel or a blood vessel.
• People with an active condition where the immune system is destroying red blood cells (haemolytic anaemia).

For all participants:

• People with active cancer spread to the brain or spinal cord (except those with primary CNS lymphoma, which is a specific eligible type — confirm with trial site).
• People with a history of a separate, different primary cancer.
• People with a condition where the immune system does not work properly from birth (primary immunodeficiency).
• People with a history of hepatitis B or hepatitis C who are currently taking antiviral medication for it.
• People with uncontrolled heart or cardiovascular disease at the time of screening, in the treating doctor's judgement.
• People who have had a severe hypertensive (very high blood pressure) crisis or related brain condition in the 3 months before screening.
• People who have had a severe allergic reaction to any of the medicines used in this trial.
• People with a brain or nervous system disorder that the treating doctor considers would make participation unsafe.
• People with certain inherited conditions affecting the bone marrow, such as Fanconi anaemia, Kostmann syndrome, or Shwachman-Diamond syndrome.
• People with an active autoimmune disease that requires ongoing immune-suppressing treatment at the time of screening (except those who only need low-dose steroids for hormone replacement).
• People who have had a stem cell transplant within 90 days before screening.
• People currently experiencing graft-versus-host disease (a complication that can follow a transplant).
• People who have received certain recent cancer treatments too close to the planned start of this trial, including some biological therapies within 28 days, other systemic anti-cancer treatments within 10 days (or 5 half-lives, whichever is shorter), or high-dose steroids for disease control within 3 days.
• People who have had radiotherapy within 4 weeks before screening.
• People who have a drainage catheter in the chest, abdomen, or around the heart, or a permanent stent in the bile duct or urinary tract (this does not apply to standard intravenous lines).
• People who have received a live vaccine within 4 weeks before screening (non-live vaccines are not excluded).
• People who have received any CD19-directed therapy — other than autologous CAR T-cell therapy — within 90 days of the planned treatment start date.

Important: Always verify eligibility with the trial site directly before applying.