Trial Search Results

A Phase 1-2 Multi-Center Study Evaluating Axicabtagene Ciloleucel in Subjects With Refractory Aggressive Non-Hodgkin Lymphoma (ZUMA-1)

This is a single arm, open-label, multi-center, phase 1/2 study, to determine the safety and efficacy of KTE-C19, an autologous anti-CD19 chimeric antigen receptor (CAR)-positive T cell therapy, in refractory aggressive Non-Hodgkin Lymphoma (NHL).

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Kite, A Gilead Company


  • Biological: axicabtagene ciloleucel


Phase 1/Phase 2


Key Inclusion Criteria

   1. Histologically confirmed:

      - Diffuse Large B Cell Lymphoma (DLBCL)

      - Primary Mediastinal Large B Cell Lymphoma (PMBCL)

      - Transformation Follicular Lymphoma (TFL)

      - High grade B-cell lymphoma (HGBCL)

   2. Chemotherapy-refractory disease, defined as one of more of the following:

      - No response to last line of therapy i. PD as best response to most recent therapy
      regimen ii. SD as best response to most recent therapy with duration no longer
      than 6 month from last dose of therapy OR

      - Refractory post-ASCT i. Disease progression or relapsed less than or equal to 12
      months of ASCT (must have biopsy proven recurrence in relapsed subjects) ii. If
      salvage therapy is given post-ASCT, the subject must have had no response to or
      relapsed after the last line of therapy

   3. Subjects must have received adequate prior therapy including at a minimum:

      - anti-CD20 monoclonal antibody unless investigator determines that tumor is
      CD20-negative and

      - an anthracycline containing chemotherapy regimen

      - for subjects with transformed FL must have received prior chemotherapy for
      follicular lymphoma and subsequently have chemorefractory disease after
      transformation to DLBCL

   4. At least one measurable lesion per revised IWG Response Criteria

   5. Age 18 or older

   6. Eastern cooperative oncology group (ECOG) performance status of 0 or 1

   7. ANC ≥ 1000/uL

   8. ALC >100/uL

   9. Platelet count ≥ 75,000/uL

10. Adequate renal, hepatic, pulmonary and cardiac function defined as:

      - Creatinine clearance (as estimated by Cockcroft Gault) > 60 mL/min

      - Serum ALT/AST <2.5 ULN

      - Total bilirubin <1.5 mg/dl, except in subjects with Gilbert's syndrome

      - Cardiac ejection fraction >50%, no evidence of pericardial effusion as determined
      by an ECHO, and no clinically significant pleural effusion

      - Baseline oxygen saturation >92% on room air

11. All subjects or legally appointed representatives/caregivers, must personally sign and
   date the IRB/IEC approved consent form before initiating any study specific procedures
   or activities.

Key Exclusion Criteria

   1. History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g.
   cervix, bladder, breast) or follicular lymphoma unless disease free for at least 3

   2. History of allogeneic stem cell transplantation

   3. Prior CAR therapy or other genetically modified T cell therapy

   4. Presence of fungal, bacterial, viral, or other infection that is uncontrolled or
   requiring IV antimicrobials for management. Simple UTI and uncomplicated bacterial
   pharyngitis are permitted if responding to active treatment

   5. History of HIV infection or acute or chronic active hepatitis B or C infection.
   Subjects with history of hepatitis infection must have cleared their infection as
   determined by standard serological and genetic testing per current Infectious Diseases
   Society of America (IDSA) guidelines

   6. Subjects with detectable cerebrospinal fluid malignant cells, or brain metastases, or
   with a history of CNS lymphoma or primary CNS lymphoma, cerebrospinal fluid malignant
   cells or brain metastases

   7. History or presence of CNS disorder such as seizure disorder, cerebrovascular
   ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Physician Referrals
Not Recruiting