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:

All groups (Cohorts 1, 2, and 3):

• Adults aged 18 or older, of any gender
• People who are willing to voluntarily take part, sign a consent form, and follow the trial's treatment and visit schedule
• People with a general health status rated as reasonably functional (scored 0–2 on a standard activity scale used by doctors)
• People whose doctors estimate they are likely to live for at least 4 more months
• People whose blood, liver, kidney, and clotting test results meet the minimum levels required by the trial (confirm specific values with trial site)
• People who are able to use highly effective contraception during the study and for at least 90 days after the last dose, or who abstain from heterosexual intercourse during that time; male participants must also agree not to donate sperm for 90 days after the last dose

Group 1 (Cohort 1) — Relapsed or refractory primary central nervous system lymphoma (PCNSL):

• People with a confirmed diagnosis of primary central nervous system lymphoma (a type of lymphoma found in the brain or spinal cord), confirmed by tissue testing
• People whose lymphoma has come back or has not responded to treatment, and who have received at least one prior course of treatment targeting the central nervous system
• People whose brain scan (MRI or CT) shows a solid tumour that is growing or has not responded to treatment

Group 2 (Cohort 2) — Relapsed or refractory chronic lymphocytic leukaemia or small lymphocytic lymphoma (CLL/SLL):

• People diagnosed with CLL or SLL according to established medical standards
• People whose CLL/SLL has come back or has not responded to treatment, and who have completed at least one prior course of standard treatment (at least 2 cycles)
• People who meet at least one standard medical reason for needing treatment for CLL/SLL
• People with medical records confirming their most recent treatment either did not work or that the disease progressed after an initial response
• People whose scans show at least one measurable lymph node larger than 1.5 cm with two measurable dimensions
• People with a stable (not active or worsening) involvement of the central nervous system may also be considered

Group 3 (Cohort 3) — Relapsed or refractory mantle cell lymphoma (MCL):

• People with a confirmed diagnosis of mantle cell lymphoma (a type of blood cancer), confirmed by tissue testing, including specific genetic or protein markers
• People who have previously received more than one but no more than three different chemotherapy or targeted drug treatments that did not work
• People with medical records confirming their most recent treatment either did not work or that the disease progressed after an initial response
• People whose scans show at least one measurable lymph node larger than 1.5 cm with two clearly measurable dimensions
• People with a stable (not active or worsening) involvement of the central nervous system may also be considered

Who may not be able to join:

All groups (Cohorts 1, 2, and 3):

• People who have received chemotherapy, targeted therapy, radiation, or antibody-based cancer treatment within 4 weeks (or 5 half-lives of the drug, whichever is shorter) before the first dose
• People who have previously been treated with certain types of targeted cancer drugs, including BTK inhibitors, PI3K inhibitors, SYK inhibitors, BCL-2 inhibitors (such as venetoclax), CAR-T cell therapy, or bispecific antibody treatments
• People who have had another cancer diagnosis within the past 3 years, with the exception of certain easily treated skin cancers, early-stage bladder cancer, or carcinoma in situ of the cervix or breast
• People who still have side effects from previous cancer treatment that have not recovered to a mild level (except for hair loss)
• People with serious or uncontrolled heart conditions, including moderate-to-severe heart failure, unstable chest pain, a heart attack within the past 6 months, certain abnormal heart rhythms, a weakened heart pump, certain inherited heart muscle diseases, or a significantly abnormal heart electrical reading on testing
• People with high blood pressure that cannot be controlled even with multiple blood pressure medications
• People who have had active bleeding in the 2 months before screening, who are taking blood-thinning or anti-clotting medications, or who are considered by doctors to have a significant risk of bleeding
• People with a history of deep vein thrombosis (blood clots in the leg veins) or pulmonary embolism (blood clots in the lungs)
• People who have had a stroke or bleeding in the brain within the 6 months before starting the study drug
• People with significant digestive system problems that could affect how the drug is swallowed or absorbed, such as difficulty swallowing, ongoing severe diarrhoea, or a bowel blockage
• People with a serious active infection that requires treatment
• People with active, uncontrolled infections at the time of screening, including HIV, active hepatitis B (unless viral levels and liver tests meet specific thresholds — confirm with trial site), or hepatitis C
• People with a history of, or current, lung scarring or serious lung disease (such as pulmonary fibrosis, interstitial pneumonia, or radiation-related lung damage)
• People who have had major surgery within 4 weeks before the first dose and have not yet fully recovered
• People currently taking part in another clinical trial, or who have taken part in an interventional clinical trial within 4 weeks before screening
• People with a history of alcohol or drug misuse
• Women who are pregnant or breastfeeding
• People taking certain medications that strongly affect how the body processes a liver enzyme called CYP3A (confirm specific medications with trial site)
• People considered unsuitable for other reasons, as determined by the trial doctors

Group 1 only (Cohort 1 — PCNSL):

• People whose lymphoma has been identified as T-cell lymphoma by tissue testing
• People who have received allogeneic stem cell transplant (a transplant using a donor's cells) or other organ transplants, unless the autologous stem cell transplant (using the person's own cells) was completed more than 6 months ago
• People who are taking high-dose steroid medication (dexamethasone 8 mg or more per day, or an equivalent amount of another steroid) to control lymphoma symptoms
• People who have had radiation therapy to the brain or central nervous system within 21 days before the first dose
• People who have been taking certain immune-suppressing medications and have not stopped them at least 28 days before the first dose, or who have been on long-term steroid treatment above a low threshold dose (confirm details with trial site)

Group 2 only (Cohort 2 — CLL/SLL):

• People with a history of prolymphocytic leukaemia, a known history of Richter syndrome, or a current suspicion of Richter transformation (a change in the nature of the leukaemia) — a biopsy may be needed to rule this out
• People who have received an allogeneic or autologous stem cell transplant within the past 6 months
• People who have used systemic steroid medications within 7 days before the first dose, or who have been on prednisone at 20 mg per day or more (or equivalent) on an ongoing basis
• People with active autoimmune anaemia or autoimmune low platelet counts that require treatment

Group 3 only (Cohort 3 — MCL):

• People who have used systemic steroid medications at 20 mg per day prednisone or equivalent or higher within 7 days before the first dose
• People who have received an allogeneic or autologous stem cell transplant or other organ transplant (confirm details with trial site)

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