Hodgkin LymphomaPhase 1NCT03925935
Trial of AB-205 in Adults With Lymphoma Undergoing High-Dose Therapy and Autologous Stem Cell Transplantation
A Phase 1 study testing AB-205 in people with Hodgkin Lymphoma and Non-hodgkin Lymphoma, run by Angiocrine Bioscience at 9 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hodgkin Lymphoma, Non-hodgkin Lymphoma
- What is being tested?
- AB-205
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 9 sitesUnited States
- Study dates
- 7 May 2019to 8 Nov 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
University of Michigan
Ann Arbor, Michigan, 48109
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
Hackensack University Medical Center
Hackensack, New Jersey, 07601
MD Anderson
Houston, Texas, 77030
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37203
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
UC Davis Comprehensive Cancer Center
Sacramento, California, 95817
UC San Diego Moores Cancer Center
San Diego, California, 92093
The University of California San Francisco
San Francisco, California, 94117
About this study
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
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.
- Conditions
- Hodgkin Lymphoma, Non-hodgkin Lymphoma
- Being tested
- AB-205
- Medical subject headings
- Hodgkin Disease, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AB-205Biological
Engineered human umbilical vein endothelial cells
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Up to 3 sequential dose escalation cohorts of AB-205 Receives: Biological: AB-205 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of adverse events grade ≥ 3 as assessed by CTCAEv5
Measured: 24 hours
Secondary outcomes (8)
Occurrence of adverse events grade ≥ 3 as assessed by CTCAEv5
Measured: 100 days
Severity and duration of grade ≥ 3 mucosal toxicities including oropharyngeal mucositis, nausea, vomiting, and/or diarrhea.
Measured: Day 0 to hospital discharge
Time to neutrophil engraftment
Measured: First of three consecutive days after ASCT of absolute neutrophil count (ANC) > 500/μL
Time to platelet engraftment
Measured: First of seven consecutive days after ASCT of platelet count ≥ 20,000/μL without transfusion support
Time to lymphoid recovery
Measured: 14, 28 and 100 days post-ASCT
Progression-free survival
Measured: 100 and 365 days post-ASCT
Non-relapse mortality
Measured: 100 and 365 days post-ASCT
Overall survival
Measured: 100 and 365 days post-ASCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2019
- Study start7 May 2019
- Primary completion18 Nov 2020
- Study completion8 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- AB-205 dose escalation based on safety.
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Angiocrine Bioscience
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- California Institute for Regenerative Medicine (CIRM)
- Responsible party
- Sponsor
- Investigators
- Paul Finnegan, MD, Study director, Angiocrine Bioscience
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03925935
- Sponsor's protocol ID
- AB-205-001
- Status last verified
- Mar 2022
- First submitted
- 22 Apr 2019
- Last updated
- 3 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03925935
- Acronym / sponsor ID
- AB-205-001
- Conditions
- Hodgkin Lymphoma, Non-hodgkin Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Angiocrine BioscienceIndustry (pharma, biotech, devices)
- Collaborators
- California Institute for Regenerative Medicine (CIRM)
- Study start
- 7 May 2019 (actual)
- Primary completion
- 18 Nov 2020 (actual)
- Study completion
- 8 Nov 2021 (actual)
- First posted
- 24 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- AB-205 dose escalation based on safety.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Biological: AB-205Up to 3 sequential dose escalation cohorts of AB-205 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Diagnosis of Hodgkin lymphoma (HL) or non-Hodgkin lymphoma (NHL) who are candidates for HDT-ASCT with one of the following conditioning regimens:
- Adjunct radiation therapy to HDT will be allowed.
- Adequate organ function is required, defined as follows:
- For female subjects of childbearing potential:
- For males who can father a child and are having intercourse with females of childbearing potential who are not using adequate contraception:
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AB-205Engineered human umbilical vein endothelial cells | Biological | Experimental |
Primary outcome
Occurrence of adverse events grade ≥ 3 as assessed by CTCAEv5
Time frame: 24 hours
8 secondary outcomes
Occurrence of adverse events grade ≥ 3 as assessed by CTCAEv5
Time frame: 100 days
Severity and duration of grade ≥ 3 mucosal toxicities including oropharyngeal mucositis, nausea, vomiting, and/or diarrhea.
Time frame: Day 0 to hospital discharge
Time to neutrophil engraftment
Time frame: First of three consecutive days after ASCT of absolute neutrophil count (ANC) > 500/μL
Time to platelet engraftment
Time frame: First of seven consecutive days after ASCT of platelet count ≥ 20,000/μL without transfusion support
Time to lymphoid recovery
Time frame: 14, 28 and 100 days post-ASCT
Progression-free survival
Time frame: 100 and 365 days post-ASCT
Non-relapse mortality
Time frame: 100 and 365 days post-ASCT
Overall survival
Time frame: 100 and 365 days post-ASCT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Finnegan, MD study director
Angiocrine Bioscience
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AB-205 in people with Hodgkin Lymphoma and Non-hodgkin Lymphoma, run by Angiocrine Bioscience at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of adverse events grade ≥ 3 as assessed by CTCAEv5 (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2022.