RightFit
RecruitingPhase 2

CAR T-cell Therapy in Patients With Renal Dysfunction

Lymphodepleting Chemotherapy With Fludarabine and Cyclophosphamide Prior to Infusion of CAR T Cell Therapy in Patients With Moderate-Severe Renal Dysfunction

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study checks whether CAR T-cell therapy, a treatment that uses immune cells, can be given to people with moderate to severe kidney problems. It is for people with multiple myeloma, leukemia, or lymphoma who get an adjusted dose of chemotherapy before CAR T-cell therapy.

This is a prospective, descriptive study designed to assess the feasibility of administering CAR T therapy among patients with moderate to severe renal impairment using dose adjusted lymphodepleting chemotherapy.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Getting chemotherapy to lower immune cell levels before commercial CAR T-cell therapy for multiple myeloma, leukemia, or lymphoma.
  • Bone marrow, which makes blood cells, works well enough to receive this chemotherapy.
  • Kidney filtering rate is 60 mL/min/1.73 m² or less.
  • ECOG score of 0–2: able to care for yourself and be out of bed for more than half the day, though some activities may be limited.

Who can't join

  • Certain disorders of the brain or spinal cord.
  • An active infection that is not controlled, or another illness that the study doctor thinks could interfere with the study.
  • Taking steroid medicine that affects the whole body at more than 20 mg of prednisone per day, or an equal dose of another steroid, within 72 hours of CAR T-cell treatment.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Receiving lymphodepleting chemotherapy prior to commercial CAR-T administration for multiple myeloma, leukemia, or lymphoma * Adequate bone marrow function to receive lymphodepleting chemotherapy * Renal function \</= 60mL/min/1.73m2 * ECOG 0-2 Exclusion Criteria: * Relative CNS disorders * Active uncontrolled infection or any other concurrent disease or medical condition that was deemed to interfere with the conduct of the study as judged by the investigator * Use of therapeutic dose systemic corticosteroids (defined as \>20mg/day prednisone or equivalent) within 72 hours of CAR-T administration

Study sites (1)

GA