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 aged 16 years or older.
• People who are able to give written, signed, and dated consent and are able to cooperate with treatment and follow-up visits.
• People with a confirmed diagnosis of B-cell non-Hodgkin lymphoma (a type of blood cancer), diagnosed according to recognised medical standards.
• People whose general health and ability to carry out daily activities falls within an acceptable range as measured by a standard medical scale (scores 0, 1, or 2 on the ECOG scale).
• People whose blood chemistry and organ function results fall within the ranges set out in the trial protocol.

For one group of participants (Phase I, Cohorts A & B) — assessed before joining the trial:

• People with a confirmed diagnosis of large B-cell lymphoma (LBCL) or mantle cell lymphoma (MCL) that has come back or stopped responding to treatment.
• People who have already received an approved type of immune cell therapy targeting a protein called CD19 (known as CAR T-cell therapy).
• People whose disease can be measured or evaluated at around 4 weeks after their CAR T-cell therapy, and whose disease either did not respond fully, is stable, has progressed (with a reasonable expectation of benefit from this trial), or responded but then returned within 9 months.
• People whose blood cell counts fall within the ranges set out in the trial protocol.

For another group of participants (Phase I, Cohorts C & D) — assessed before a preparatory chemotherapy step prior to CAR T therapy:

• People with a confirmed diagnosis of large B-cell lymphoma (LBCL) or mantle cell lymphoma (MCL) that has come back or stopped responding to treatment.
• People who have been approved by the UK national specialist panel (the CAR T Clinical Panel) to receive an approved CD19-targeting CAR T-cell therapy.
• People whose blood cell counts fall within the ranges set out in the trial protocol.
• People with adequate heart function and no symptoms or signs of heart failure, based on tests specified in the protocol.
• People whose resting blood oxygen level is 92% or above when breathing normal room air.

For Phase II of the trial:

• Eligibility criteria for Phase II participants will be determined based on the timing of treatment, as recommended by the trial's Safety Review Committee (confirm with trial site).

Who may not be able to join:

• People who have, or have had, another type of cancer that the treating doctor considers a reason to exclude them — though some exceptions apply, such as certain skin cancers, some early-stage cervical conditions, asymptomatic prostate cancer meeting specific criteria, or people who had a previous cancer, have had no signs of it for 2 or more years, and are considered at negligible risk of it returning.
• People still experiencing significant side effects from previous cancer treatments that the treating doctor considers a reason for exclusion.
• People who need ongoing medication to suppress their immune system (other than low replacement doses of steroids) — though occasional use of topical, inhaled, or nasal steroid sprays is permitted.
• People with active infections or active inflammatory conditions that require ongoing medical management.
• People whose lymphoma has spread to the brain or spinal cord (central nervous system).
• Women who could become pregnant, are already pregnant, or are breastfeeding, unless they are willing to follow the contraception requirements set out in the trial protocol.
• Men whose partners could become pregnant, unless they are willing to follow the contraception requirements set out in the trial protocol.
• People who have recently had major chest or abdominal surgery and have not yet fully recovered.
• People considered to be at high medical risk due to serious non-cancer illness, including uncontrolled active infection.
• People with a known allergy or sensitivity to any ingredient in the trial treatment (ALETA-001).
• People who are currently taking part in another clinical trial that involves receiving an experimental treatment.
• People with an inherited or acquired condition affecting their immune system, or who are receiving immune-suppressing medications (including any dose of systemic steroids), or who are immunosuppressed following an organ transplant — though people using inhaled steroids, or those with a history of allergies (other than severe anaphylaxis) or autoimmune conditions, may still be eligible (confirm with trial site).
• People for whom the treating doctor considers the trial would not be in their best interests, for any other reason.
• People currently receiving radiotherapy, except when used for pain relief (palliative purposes).

Additional exclusions for one group (Phase I, Cohorts A & B):

• People who have received any other systemic cancer treatment after their CAR T-cell therapy.
• People who experienced severe immune reactions (called CRS or ICANS) during their initial CAR T-cell therapy, specifically: a grade 4 reaction; or a grade 3 or higher reaction lasting more than 7 days despite full treatment; or any remaining symptoms of these reactions that have not fully resolved.
• People who experienced severe side effects affecting organs (other than blood-related side effects) after CAR T therapy that have not improved to a mild level for at least 48 hours before the trial treatment infusion.

Additional exclusions for another group (Phase I, Cohorts C & D) — assessed before the trial treatment infusion, given between days 10 and 18 after CAR T-cell therapy:

• People who experienced a grade 4 immune reaction (CRS or ICANS) after their CAR T-cell infusion.
• People who experienced a grade 3 or higher immune reaction (CRS or ICANS) that lasted more than 7 days despite full treatment.
• People whose immune reaction symptoms (CRS or ICANS) have not improved to a very mild level (grade 1 or below) for at least 48 hours before the trial treatment infusion.
• People whose general health and ability to carry out daily activities has declined significantly (ECOG score of 3 or higher) at the time of the planned trial treatment.
• People who experienced severe organ side effects (other than blood-related) after CAR T therapy that have not improved to a mild level for at least 48 hours before the trial treatment infusion.
• People with a serious unresolved active infection that the treating doctor believes would make it unsafe to proceed with the trial treatment infusion.

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