Phase 2 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:

• People diagnosed with relapsed or refractory B-cell acute lymphoblastic leukaemia (B-ALL) — meaning the cancer has come back or has not responded to treatment — where cancer cells are still detectable in the bone marrow, and the person has either relapsed, not responded to treatment, or is not suitable for a stem cell transplant. For relapsed cases, a test confirming the cancer cells carry the CD19 marker must have been done within the past 3 months.
• People diagnosed with large B-cell lymphoma that has come back or not responded to treatment after at least two rounds of systemic (whole-body) treatment, including specific subtypes such as diffuse large B-cell lymphoma (DLBCL) and related types.
• Both children under 18 and adults aged 18 and over are being considered (in separate groups).
• People whose heart, liver, kidneys, and other organs are functioning adequately (confirm with trial site for specific levels required).
• People whose life expectancy is estimated to be more than 12 weeks at the time of screening.
• People with a performance status score of 50 or above on the relevant scale for their age — this is a medical measure of how well a person is able to carry out daily activities (confirm with trial site).
• People who meet the facility's requirements for a cell collection procedure called leukapheresis, or who already have a suitable cell sample collected and accepted by the manufacturing site.

Who may not be able to join:

• People with B-ALL where the cancer has relapsed only outside the bone marrow, with no involvement inside the bone marrow.
• People with certain inherited genetic conditions affecting the bone marrow, such as Fanconi anaemia, Kostmann syndrome, or Shwachman syndrome. Note: people with Down syndrome are not excluded on this basis.
• People with a specific type of fast-growing leukaemia/lymphoma called Burkitt's lymphoma or leukaemia.
• People with active or latent (dormant) hepatitis B, active hepatitis C, HIV (based on a test within the past 8 weeks), or any infection that is not currently under control.
• People with a moderate to severe complication called graft-versus-host disease (a condition that can occur after a stem cell transplant where donor cells attack the body).
• People with active cancer involvement in the central nervous system (brain and spinal cord), classified as CNS-3. People with a lower level of CNS involvement (CNS-2) or a treated history of CNS disease may still be considered.
• People who have taken part in another clinical trial using an experimental treatment within the 30 days before screening.
• People who are pregnant or breastfeeding.
• Women who could potentially become pregnant, and all male participants, unless highly effective contraception is used for one year after receiving the CAR T-cell treatment. Women who could potentially become pregnant must also have a negative pregnancy test within 48 hours before receiving the treatment.

The following are not automatic exclusions but must be discussed with the trial team:

• People who have had a previous cancer diagnosis, other than certain treated skin or cervical cancers with no current signs of disease.
• People who have previously received a gene therapy treatment.
• People who have previously received treatments targeting the CD19 or CD3 proteins on cancer cells.

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