Immune Cell Therapy (CAR-T) for the Treatment of Patients With HIV and B-Cell Non-Hodgkin Lymphoma

Part of paid clinical trials in Duarte, California.

Sponsor
AIDS Malignancy Consortium
Study ID
NCT05077527
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • AIDS-Related Diffuse Large B-cell Lymphoma
  • AIDS-Related Non-Hodgkin Lymphoma
  • HIV Infection
  • Recurrent Diffuse Large B-Cell Lymphoma
  • Recurrent Grade 3b Follicular Lymphoma
  • Recurrent High Grade B-Cell Lymphoma
  • Recurrent Non-Hodgkin Lymphoma
  • Recurrent Primary Mediastinal (Thymic) Large B-Cell Lymphoma
  • Recurrent Transformed B-Cell Non-Hodgkin Lymphoma
  • Refractory Diffuse Large B-Cell Lymphoma
  • Refractory Grade 3b Follicular Lymphoma
  • Refractory High Grade B-Cell Lymphoma
  • Refractory Non-Hodgkin Lymphoma
  • Refractory Primary Mediastinal (Thymic) Large B-Cell Lymphoma
  • Refractory Transformed B-Cell Non-Hodgkin Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Axicabtagene Ciloleucel — BIOLOGICAL
    Given IV
  • Cyclophosphamide — DRUG
    Given IV
  • Fludarabine — DRUG
    Given IV

Study Details

This phase I trial evaluates the side effects and usefulness of axicabtagene clioleucel (a CAR-T therapy) and find out what effect, if any, it has on treating patients with HIV-associated aggressive B-cell non-Hodgkin lymphoma that has come back (relapsed) or not responded to treatment (refractory). T cells are infection fighting blood cells that can kill tumor cells. Axicabtagene ciloleucel consists of genetically modified T cells, modified to recognize CD-19, a protein on the surface of cancer cells. These CD-19-specific T cells may help the body's immune system identify and kill CD-19-positive B-cell non-Hodgkin lymphoma cells.

Key Dates

Start date
Feb 13, 2025
Status verified
Apr 2026
Primary completion
Jan 31, 2028
Completion
Jan 31, 2029

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (conditioning, axicabtagene ciloleucel)
    Patients receive fludarabine IV over 30 minutes and cyclophosphamide IV over 1 hour on days -5, -4, and -3. Patients then receive axicabtagene ciloleucel IV over 30 minutes on day 0.

Primary Outcome Measure

Safety of chimeric antigen receptor (CAR) T-cell therapy [ Time Frame: Up to 2 years ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
City of Hope Comprehensive Cancer CenterDuarteCalifornia91010
John Baird, MD
[email protected]
626-218-3306
John Baird, MD (PRINCIPAL_INVESTIGATOR)
University of Illinois at ChicagoChicagoIllinois60612
Paul Rubinstein
[email protected]
3129961581
Paul Rubinstein, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Maria Palomba, MD
[email protected]
646-608-3711
Maria Palomba, MD (PRINCIPAL_INVESTIGATOR)
The Ohio state UniversityColumbusOhio43210
Hanna Cordes, BA,BS
[email protected]
614-293-4208
John McCarthy, Ba
[email protected]
(614) 685-0808
Polina Shindiapina, Phd,MD,BS (PRINCIPAL_INVESTIGATOR)
University of Pennsylvania / Abramson Cancer CenterPhiladelphiaPennsylvania19104
Brittany Koch
[email protected]
215-776-5548
Kaitlin Kennard
[email protected]
267-804-4080
Colin Thomas, MD (PRINCIPAL_INVESTIGATOR)
Huntsman Cancer Institute, University of UtahSalt Lake CityUtah84112
Katy Ralston
[email protected]
8015850255
Margaret K Baron, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Duarte, CA

By condition
HIV
By specialty
Infectious disease
By research site
City of Hope Comprehensive Cancer Center· Duarte, CAUniversity of Illinois at Chicago· Chicago, ILMemorial Sloan Kettering Cancer Center· New York, NYThe Ohio state University· Columbus, OHUniversity of Pennsylvania / Abramson Cancer Center· Philadelphia, PAHuntsman Cancer Institute, University of Utah· Salt Lake City, UT

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