A Study of the Effects of AB-205 in Patients With Lymphoma Undergoing Autologous Hematopoietic Cell Transplantation

Study Overview
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Brief Summary
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High-dose chemotherapy followed by blood stem cell transplantation is administered to lymphoma patients with an intention to cure. However, high-dose chemotherapy simultaneously causes damage to healthy tissues that frequently result in severe complications that lead to hospitalization and can be life threatening. These severe complications involve the blood, immune, gastro-intestinal systems, and other vital organs. The purpose of this study is to determine if experimental therapy AB-205 (study drug) can prevent or reduce the occurrence and duration of the severe chemotherapy related complications when compared to placebo in patients with lymphoma undergoing treatment with high-dose chemotherapy and blood stem cell transplantation. All patients, whether treated with AB-205 or placebo, will receive standard preventive and supportive care therapies.

Official Title
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A Phase 3 Double-Blind, Randomized, Placebo Controlled Study to Evaluate the Efficacy and Safety of AB-205 Plus Standard of Care Versus Placebo Plus Standard of Care in Adults With Lymphoma Undergoing High-Dose Therapy and Autologous Hematopoietic Cell Transplantation (HDT-AHCT) (E-CELERATE)

Conditions
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Hodgkin Lymphoma, Non Hodgkin Lymphoma

Intervention / Treatment
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* Biological: AB-205
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 40 years old Diagnosis of Hodgkin lymphoma (HL) or non-Hodgkin lymphoma (NHL) Candidates for HDT-AHCT with one of the following conditioning regimens: BEAM (carmustine, etoposide, cytarabine, melphalan) BeEAM (bendamustine, etoposide, cytarabine, melphalan) Achieved CR or PR prior to planned HDT ECOG ≤ 2 Weight ≤ 1.6 × ideal body weight (IBW) per Devine formula Serum bilirubin ≤ 2 mg/dL, unless benign congenital hyperbilirubinemia AST, ALT, and alkaline phosphatase < 3 × ULN Creatinine clearance ≥ 30 ml/min (calculated by Cockcroft Gault) LVEF ≥ 45% by MUGA or resting echocardiogram Pulmonary function (FEV1 and corrected DLCO) ≥ 45% predicted Willingness and ability to comply with scheduled visits, drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions Sexually active females of childbearing potential must have a negative urine pregnancy test and agree to use two accepted methods of contraception during the study and for 3 months after their last dose of study drug. Male subjects who are sexually active and who are partners of females of childbearing potential: agreement to use two forms of contraception as in criterion 12 above and to not donate sperm during the treatment period and for at least 3 months after the last dose of study drug Ability to provide written informed consent. Exclusion Criteria: History of prior HCT Primary CNS lymphoma Lymphoma with CNS involvement at time of relapse prior to planned HDT-AHCT Active malignancy other than the one for which the subject is undergoing HDT AHCT. 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 Subjects with a known history of HIV 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 require reduced dose (intensity) of BEAM or BeEAM regimens

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AB-205 plus standard-of-care preventive and supportive therapies.<br> | Biological: AB-205<br>* Allogeneic genetically engineered human umbilical vein endothelial cells<br>* Other names: E-CEL cells;|
| Placebo Comparator: Placebo plus standard-of-care preventive and supportive therapies.<br> | Other: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The absence of oral/GI severe regimen related toxicities (oral/GI SRRT). |  | 21 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of oral/GI SRRT |  | 21 Days | 
| Symptom burden per MD Anderson Symptom Inventory (MDASI) |  | 21 Days | 
| Duration of febrile neutropenia |  | 21 Days | 
| Time to neutrophil engraftment |  | 21 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lymphoma, Cellular Therapy