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A Phase 2 Multicenter Study of Axicabtagene Ciloleucel in Subjects With Relapsed/Refractory Indolent Non-Hodgkin Lymphoma


Trial ID:NCT03105336

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Protocol #:17-075

DiseasesNon-Hodgkin's Lymphoma

Principal Investigator:Caron Jacobson. M.D

Trial Description:
This study will enroll approximately 50 adult subjects who have relapsed or refractory (r/r) iNHL to be infused with the study treatment, axicabtagene ciloleucel, to see if their disease responds to this experimental product and if this product is safe. Axicabtagene ciloleucel is made from the subjects own white blood cells which are genetically modified and grown to fight cancer. An objective response rate of 70% is targeted.

Kathleen McDermott, Dana-Farber Cancer Institute,

Conducting Institutions:
Brigham and Women's Hospital
Dana-Farber Cancer Institute

Eligibilty Requirements:
Inclusion Criteria:

- 1) Subject has [follicular lymphoma that has progressed within 24 months of first diagnosis and treatment with combination chemoimmunotherapy] (e.g. R-bendamustine, R-CHOP) OR Progression of iNHL within 6 months of completion of second or later line therapy containing both an anti-CD20 antibody and alkylating agent OR Progression of iNHL at any point following autologous transplantation.

2) Subject has [measurable disease].

3) Subject has no known presence or history of CNS involvement by lymphoma.

4) If subject is on conventional systemic therapy or systemic inhibitory/stimulatory immune checkpoint therapy, subject is able to stop conventional therapy 2 weeks or 5 half-lives, whichever is shorter, or immune checkpoint therapy 3 half-lives prior to planned leukapheresis.

5) Subject has ECOG performance status of 0-1 and adequate renal, hepatic, pulmonary, and cardiac function

6) Subject is not pregnant or breastfeeding (female subjects only) and is willing to use birth control from the time of consent through 6 months following CAR T cell infusion (both male and female subjects).B24

Exclusion Criteria:

- 1) Transformed FL

2) Small lymphocytic lymphoma

3) Histological Grade 3b FL

4) Subject will have undergone autologous transplant within 6 weeks of planned leukapheresis or has undergone allogeneic transplant.

5) Subject has evidence of involvement of the heart by lymphoma or requirement for urgent therapy due to ongoing or impending oncologic emergency (e.g. mass effect, tumor lysis syndrome, etc.)