Phase 2 Lymphoma Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
Adults (aged 18 and over):
- People aged 18 or over with a confirmed type of blood cancer that carries a specific protein called CD19 — this includes certain types of leukaemia (ALL, CLL) or lymphoma (DLBCL, FL, or MCL)
- People with ALL (a type of leukaemia) whose cancer has come back or stopped responding to treatment, including after a bone marrow transplant from a donor (at least 6 months prior), after two or more previous treatments, or whose cancer never fully responded to at least two treatments
- People with CLL (a type of leukaemia) whose cancer came back within 2 years of chemotherapy, or who have not responded to or cannot tolerate certain targeted therapies, or whose cancer returned after a donor bone marrow transplant
- People with DLBCL (an aggressive lymphoma) whose cancer has not responded to a second or later round of chemotherapy, or has returned after a stem cell transplant
- People with FL (a slower-growing lymphoma) whose cancer returned within 2 years of chemotherapy and who are not suitable for, or have not benefited from, a stem cell transplant or a specific targeted treatment
- People with MCL (a type of lymphoma) whose cancer returned after standard first treatment and who are not suitable for, or have not benefited from, a specific targeted therapy
- People whose cancer is still measurable or detectable at the time of enrolment
- People with a life expectancy of at least 12 weeks
- People who are well enough to carry out basic daily activities (assessed using a standard medical scale)
- People whose kidneys, liver, lungs, and heart are functioning at an adequate level, based on blood tests and heart scans
- People with sufficient numbers of certain white blood cells in their blood
- Women who could become pregnant, and men, who agree to use highly effective contraception for one year after receiving the treatment
- People who are able to understand what the trial involves and who provide written consent before any trial screening takes place
Children and teenagers (aged 3 to under 18):
- Children and teenagers aged over 3 and under 18 with confirmed CD19+ ALL (a type of leukaemia)
- Young people whose ALL has come back or not responded to treatment, including after a donor bone marrow transplant (at least 6 months prior), after two or more previous treatments, or whose cancer never fully responded to at least two treatments
- Young people whose cancer is still measurable or detectable at the time of enrolment
- Young people with a life expectancy of at least 12 weeks
- Young people who are well enough to carry out basic daily activities (assessed using an age-appropriate standard medical scale)
- Young people whose kidneys, liver, lungs, and heart are functioning at an adequate level
- Young people with sufficient numbers of certain white blood cells in their blood
- Young women who could become pregnant, and post-pubertal males, who agree to use highly effective contraception for one year after receiving the treatment
- Written consent must be provided by the young person and/or their legal guardian before any trial screening takes place
Who may not be able to join:
Adults (aged 18 and over):
- People currently taking immune-suppressing medications, unless the dose is at or below a low threshold (confirm with trial site)
- People whose chemotherapy or immunotherapy has not been stopped at least 2 weeks before the cell collection procedure (though treatment may continue between cell collection and the preparation phase)
- People who have received a donor immune cell infusion (DLI) within the past 6 weeks
- People with active or ongoing graft-versus-host disease (a complication that can occur after a donor transplant)
- People with uncontrolled active hepatitis B or C
- People who are HIV-positive
- People with a serious, uncontrolled infection (bacterial, viral, or fungal)
- People with severe ongoing health conditions such as uncontrolled high blood pressure, serious heart failure, uncontrolled diabetes, or uncontrolled high cholesterol
- People who have had unstable chest pain or a heart attack within the past 3 months
- People with a current or previous separate cancer — with exceptions for: certain treated skin cancers, cervical or breast cancer in remission for at least 3 years with no recurrence, CLL or FL that has transformed into the type of lymphoma being studied, or any cancer that has been in complete remission for at least 5 years
- Women who are pregnant or breastfeeding
- People who have a known intolerance to the ingredients used in preparing the cell treatment
- People currently participating in another clinical trial at the time of screening
- People with severe CNS (brain/spinal cord) disease at a specific stage at the time of the pre-treatment assessment (confirm with trial site)
Children and teenagers (aged 3 to under 18):
- Young people currently taking immune-suppressing medications above a low weight-based dose threshold (confirm with trial site)
- Young people whose chemotherapy or immunotherapy has not been stopped at least 2 weeks before the cell collection procedure
- Young people who have received a donor immune cell infusion (DLI) within the past 6 weeks
- Young people with active or ongoing graft-versus-host disease
- Young people with uncontrolled active hepatitis B or C
- Young people who are HIV-positive
- Young people with a serious, uncontrolled infection (bacterial, viral, or fungal)
- Young people with a severe ongoing health condition (such as a life-limiting genetic disorder) — though young people with Down Syndrome are not excluded
- Young people with a current or previous separate cancer — with exceptions for lymphoma that has transformed into the type of leukaemia being studied, or any cancer that has been in complete remission for at least 5 years
- Young women who are pregnant or breastfeeding
- Young people with a known intolerance to the ingredients used in preparing the cell treatment
- Young people currently participating in another clinical trial at the time of screening
- Young people with severe CNS (brain/spinal cord) disease at a specific stage at the time of the pre-treatment assessment (confirm with trial site)
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Prof. Dr. Michael Schmitt, University Hospital Heidelberg, Department V
Phone: +49-6221-566614
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Safety of CD19.CAR T cell administration assessing grade and frequency of toxicities including cytokine release syndrome (CRS) and neurotoxicity according to Common Toxicity Criteria for Adverse Events (CTCAE); Feasibility of CD19.CAR T cell manufacturing assessing the number of transduced T cells
Can't join this trial?
Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.