Recruiting
Phase 2

CAR T-cell Therapy

Sponsor:

Northside Hospital, Inc.

Code:

NCT05909059

Conditions

Non-hodgkin Lymphoma,B Cell

Multiple Myeloma

Acute Lymphoblastic Leukemia, Adult

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Fludarabine

Cyclophosphamide

Study Details

Brief summary:

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.

Conditions

Non-hodgkin Lymphoma,B Cell

Multiple Myeloma

Acute Lymphoblastic Leukemia, Adult

Study ID

NCT05909059

Start date

Nov 18, 2024

Status verified date

Apr, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Moderate Renal Dysfunction

Moderate renal dysfunction will receive a 20% dose reduction of fludarabine and no dose reduction for cyclophosphamide.

experimental: Severe Renal Dysfunction

Several renal dysfunction will receive a 40% dose reduction of fludarabine and no dose reduction for cyclophosphamide.

experimental: Dialysis Participants

Participants on dialysis will receive a 50% dose reduction of fludarabine and a 25% dose reduction of cyclophosphamide.

Interventions

Fludarabine

Received IV on Days -5 to -3 before CAR T cell therapy

Cyclophosphamide

Received IV on Days -5 to -3 before CAR T cell therapy

Primary outcome measure

  • Occurrence of CRS [ Time Frame: 90 days ]
  • Occurrence of ICANS [ Time Frame: 90 days ]
  • Occurrence of Cytopenias [ Time Frame: 90 days ]

Central Contacts and Locations

Central contacts

Melhem Solh, MD

404-255-1930msolh@bmtga.com

Caitlin Guzowski, MBA, MHA

404-851-8523caitlin.guzowski@northside.com

Locations

Caitlin Guzowski

Recruiting

Atlanta, Georgia, United States, 30342

Contacts

Caitlin Guzowski, MBA, MHA

404-851-8523caitlin.guzowski@northside.com

Principal Investigator:

Melhem Solh, MD

More Information

Sponsor

Northside Hospital, Inc.

Last update posted

Apr 20, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Northside Hospital, Inc. on 2026-04-20.