Clinical trial NCT03925935: Trial of AB-205 in Adults With Lymphoma Undergoing High-Dose Therapy and Autologous Stem Cell Transplantation
Official title: A Phase 1, Open Label, Non-randomized, Multi-Center Trial of AB-205 in Adults With Lymphoma Undergoing High-Dose Therapy and Autologous Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hodgkin Lymphoma
Non-hodgkin Lymphoma
Lead sponsor: Angiocrine Bioscience
Sponsor class: INDUSTRY
Collaborators: name: California Institute for Regenerative Medicine (CIRM)
First posted: 2019-04-24
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: AB-205 dose escalation based on safety.
Primary purpose: TREATMENT

Brief summary: A phase 1, open label, multi-center trial of AB-205 in adults with Hodgkin or non-Hodgkin lymphoma who are in chemo-sensitive remission undergoing high-dose therapy, with or without radiation, and autologous stem cell transplantation (HDT-ASCT). Subjects will receive AB-205 infusion following autologous stem cell transfusion on Day 0.


Eligibility criteria: INCLUSION CRITERIA

* Diagnosis of Hodgkin lymphoma (HL) or non-Hodgkin lymphoma (NHL) who are candidates for HDT-ASCT with one of the following conditioning regimens:

  * carmustine, etoposide, cytarabine, melphalan (BEAM)
  * cyclophosphamide, carmustine, etoposide (CBV)
  * thiotepa, busulphan, cyclophosphamide (TBC)
  * additional myeloablative chemotherapy-based conditioning regimens may be permitted with the approval of the medical monitor
* Adjunct radiation therapy to HDT will be allowed.
* Adequate organ function is required, defined as follows:

  * Serum bilirubin ≤ 2 mg/dL, unless benign congenital hyperbilirubinemia
  * AST, ALT, and alkaline phosphatase \< 3 times the upper limit of normal
  * Creatinine clearance ≥ 40 ml/min (calculated by Cockcroft Gault)
  * LVEF ≥ 45% by MUGA or resting echocardiogram
  * Pulmonary function (FEV1 and corrected DLCO) ≥ 45% predicted
  * Adequate performance status ECOG ≤1
* For female subjects of childbearing potential:

  * A negative serum or urine pregnancy test at screening.
  * Subject must be willing to use a recommended method of contraception from the start of the screening period and throughout the study period.
* For males who can father a child and are having intercourse with females of childbearing potential who are not using adequate contraception:

  - Subject must be willing to use a recommended method of contraception and refrain from sperm donation from the start of conditioning therapy for at least 1 year after completion and discussion with a treating physician.
* Willingness and ability to comply with scheduled visits, drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions.
* Ability to provide written informed consent.

EXCLUSION CRITERIA

* History of prior ASCT.
* Active malignancy other than the one for which the subject is undergoing HDT-ASCT. (Subjects with cervical carcinoma in situ or localized basal or squamous cell carcinoma treated with definitive surgery are eligible.)
* Subjects with a serious concomitant medical condition that could interfere with the conduct of the clinical trial, such as unstable angina, renal failure requiring hemodialysis, or active infection requiring IV antibiotics.
* Active Human Immunodeficiency Virus (HIV) infection and Acquired Immunodeficiency Syndrome (AIDS).
* Females who are pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 30 days or longer after chemotherapy treatment discontinuation if required by prescribing information for chemotherapy agents received during the study.
* Subjects who have known hypersensitivity reactions to bovine (cow) proteins or documented allergy to DMSO.
* Subject has other conditions that in the opinion of the investigator would place the subject at increased risk for toxicity by participation in the study.

Primary outcomes:
measure: Occurrence of adverse events grade ≥ 3 as assessed by CTCAEv5
timeFrame: 24 hours
Secondary outcomes:
measure: Occurrence of adverse events grade ≥ 3 as assessed by CTCAEv5
timeFrame: 100 days
measure: Severity and duration of grade ≥ 3 mucosal toxicities including oropharyngeal mucositis, nausea, vomiting, and/or diarrhea.
timeFrame: Day 0 to hospital discharge
measure: Time to neutrophil engraftment
timeFrame: First of three consecutive days after ASCT of absolute neutrophil count (ANC) > 500/μL
measure: Time to platelet engraftment
timeFrame: First of seven consecutive days after ASCT of platelet count ≥ 20,000/μL without transfusion support
measure: Time to lymphoid recovery
timeFrame: 14, 28 and 100 days post-ASCT
measure: Progression-free survival
timeFrame: 100 and 365 days post-ASCT
measure: Non-relapse mortality
timeFrame: 100 and 365 days post-ASCT
measure: Overall survival
timeFrame: 100 and 365 days post-ASCT
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Comprehensive Cancer Center
state: California
city: Sacramento
country: United States
facility: UC Davis Comprehensive Cancer Center
state: California
city: San Diego
country: United States
facility: UC San Diego Moores Cancer Center
state: California
city: San Francisco
country: United States
facility: The University of California San Francisco
state: California
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
city: Houston
country: United States
facility: MD Anderson
state: Texas
Study officials:
affiliation: Angiocrine Bioscience
name: Paul Finnegan, MD
role: STUDY_DIRECTOR
References: