NCT04223765View on ClinicalTrials.gov

Study of Kappa Chimeric Antigen Receptor (CAR) T Lymphocytes Co-Expressing the Kappa and CD28 CARs for Relapsed/Refractory Kappa+ Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma.

PHASE1RecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

November 12, 2020

Primary Completion Date

March 22, 2028

Study Completion Date

March 22, 2043

Conditions
Mantle Cell LymphomaFollicular LymphomaSplenic Marginal Zone LymphomaExtranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid TissueNodal Marginal Zone LymphomaIndolent Non-hodgkin Lymphoma
Interventions
DRUG

CAR.k.28

Three dose levels will be evaluated: Dose level 1 (5x10\^5 cells/kg), Dose level 2 (1x10\^6), and dose level 3 (2x10\^6 cells/kg).

DRUG

Fludarabine

30 mg/m\^2/day IV for 3 consecutive days

DRUG

Cyclophosphamide

500 mg/m\^2/day IV for 3 consecutive days

DRUG

Bendamustine

70 mg/m\^2/day administered over 3 consecutive days.

Trial Locations (1)

27599

RECRUITING

Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

UNC Lineberger Comprehensive Cancer Center

OTHER

NCT04223765 - Study of Kappa Chimeric Antigen Receptor (CAR) T Lymphocytes Co-Expressing the Kappa and CD28 CARs for Relapsed/Refractory Kappa+ Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma. | Biotech Hunter | Biotech Hunter