LymphomaPhase 1NCT03189836
Study of ACTR707 in Combination With Rituximab in Subjects With Relapsed or Refractory B Cell Lymphoma
A Phase 1 study testing ACTR707 and rituximab in people with Lymphoma, run by Cogent Biosciences, Inc. at 11 sites in United States.
Trial summary
This is a phase 1, multi-center, single-arm, open-label study evaluating the safety and anti-lymphoma activity of an autologous T cell product (ACTR707) in combination with rituximab in subjects with refractory or relapsed CD20+ B cell lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- ACTR707 and rituximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 11 sitesUnited States
- Study dates
- 4 Oct 2017to 21 Sep 2020
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- signed written informed consent obtained prior to study procedures
- histologically-confirmed relapsed or refractory CD20+ B-cell lymphoma of one of the following types, with documented disease progression or recurrence following the immediate prior therapy: DLBCL (regardless of cell of origin or underlying molecular genetics), MCL, PMBCL, Gr3b-FL, TH-FL (prior dx of FL before transforming to DLBCL).
- biopsy-confirmed CD20+ expression of the underlying malignancy with disease progression following immediate prior therapy
- at least 1 measurable lesion on imaging.
- must have received adequate prior therapy for the underlying CD20+ B-cell lymphoma, defined as an anti-CD20 mAb in combination with an anthracycline-containing chemotherapy regimen (i.e. chemo-immunotherapy) and at least one of the following:
- biopsy-proven refractory disease after frontline chemo-immunotherapy
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- relapse within 1 year from frontline chemo-immunotherapy and ineligible for autologous hematopoietic stem cell transplant (auto-HSCT)
- for subjects with DLBCL, PMBCL, and Gr3b-FL: relapsed or refractory disease following at least 2 prior regimens or following an auto-HSCT
- for subjects with TH-FL: relapsed or refractory disease following at least 2 prior regimens or following an auto-HSCT. At least 1 prior regimen with an anti-CD20 mAb in combination with chemotherapy is required following documented transformation
- for subjects with MCL (confirmed with cyclin D1 expression or evidence of t(11;14) by cytogenetics, fluorescent in situ hybridization (FISH) or polymerase chain reaction (PCR): relapsed or refractory disease after at least 1 prior regimen with chemo-immunotherapy (prior auto-HSCT is allowable)
- ECOG 0 or 1
- life expectancy of at least 6 months
- platelet count greater than 50,000/µL
Who cannot join
- known active central nervous system (CNS) involvement by malignancy.
- prior treatment as follows:
- alemtuzumab within 6 months of enrollment
- fludarabine, cladribine, or clofarabine within 3 months of enrollment
- external beam radiation within 2 weeks of enrollment
- mAb (including rituximab) within 2 weeks of enrollment
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- other lymphotoxic chemotherapy (including steroids except as below) within 2 weeks of enrollment
- experimental agents within 3 half-lives prior to enrollment, unless progression is documented on therapy
- clinically significant cardiac disease
- clinically significant active infection
- clinically significant CNS disorder
- clinical history, prior diagnosis, or overt evidence of autoimmune disease
- known bone marrow involvement due to underlying malignant disease, in dose-escalation phase only
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Emory University, Winship Cancer Institute
Atlanta, Georgia, 30322
University of Maryland
Baltimore, Maryland, 21201
Ohio State University
Columbus, Ohio, 43210
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Indiana Bone and Marrow Transplantation
Indianapolis, Indiana, 46327
Loyola University
Maywood, Illinois, 60153
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
University of Minnesota
Minneapolis, Minnesota, 55455
Tennessee Oncology - Nashville
Nashville, Tennessee, 37203
Yale University
New Haven, Connecticut, 06520
About this study
Official title: Phase 1 Study of ACTR707, an Autologous T Cell Product, in Combination With Rituximab, in Subjects With Relapsed or Refractory CD20+ B Cell Lymphoma
This is a phase 1, multi-center, single-arm, open-label study evaluating the safety and anti-lymphoma activity of an autologous T cell product (ACTR707) in combination with rituximab in subjects with refractory or relapsed CD20+ B cell lymphoma.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACTR707Biological
autologous T cell product
rituximabBiological
CD20-directed cytolytic antibody
| Study group | Role | What they receive |
|---|---|---|
| ACTR707 in combination with rituximab | Experimental | Not described Receives: Biological: ACTR707; Biological: rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as assessed by dose limiting toxicities (DLTs)
Dose-limiting toxicities, MTD, incidence and severity of AEs and clinically significant abnormalities of laboratory values
Measured: 28 days
Determination of maximum tolerated dose and proposed recommended Phase 2 dose
Measured: 24 weeks
Secondary outcomes (8)
Anti-lymphoma activity as measured by overall response rate
Measured: 24 weeks
Anti-lymphoma activity as measured by duration of response
Measured: 24 weeks
Anti-lymphoma activity as measured by progression-free survival
Measured: 24 weeks
Anti-lymphoma activity as measure by overall survival
Measured: 24 weeks
Assessment of persistence of ACTR707 as measured by flow cytometry and qPCR
Measured: 24 weeks
Assessment of ACTR707 phenotype and function as measured by flow cytometry
Measured: 24 weeks
Assessment of inflammatory markers and cytokines/chemokines
Cytokines and Inflammatory markers
Measured: 24 weeks
Rituximab PK
Rituximab plasma concentration
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2017
- Study start4 Oct 2017
- Primary completion21 Sep 2020
- Study completion21 Sep 2020
Why it stopped: Business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cogent Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jessica Sachs, MD, Study director, Cogent Biosciences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03189836
- Sponsor's protocol ID
- ATTCK-20-03
- Status last verified
- Oct 2021
- First submitted
- 12 Jun 2017
- Last updated
- 11 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2.
PubMed 34515338
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of ACTR707, an Autologous T Cell Product, in Combination With Rituximab, in Subjects With Relapsed or Refractory CD20+ B Cell Lymphoma
- ClinicalTrials.gov ID
- NCT03189836
- Acronym / sponsor ID
- ATTCK-20-03
- Conditions
- Lymphoma
- Keywords
- CD20+, B cell, ACTR, ACTR707, relapsed, refractory, T cell, T cell product
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Cogent Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Oct 2017 (actual)
- Primary completion
- 21 Sep 2020 (actual)
- Study completion
- 21 Sep 2020 (actual)
- First posted
- 16 Jun 2017 (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.
This is a phase 1, multi-center, single-arm, open-label study evaluating the safety and anti-lymphoma activity of an autologous T cell product (ACTR707) in combination with rituximab in subjects with refractory or relapsed CD20+ B cell lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACTR707 in combination with rituximab | Experimental | Biological: ACTR707, Biological: rituximab |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- signed written informed consent obtained prior to study procedures
- histologically-confirmed relapsed or refractory CD20+ B-cell lymphoma of one of the following types, with documented disease progression or recurrence following the immediate prior therapy: DLBCL (regardless of cell of origin or underlying molecular genetics), MCL, PMBCL, Gr3b-FL, TH-FL (prior dx of FL before transforming to DLBCL).
- biopsy-confirmed CD20+ expression of the underlying malignancy with disease progression following immediate prior therapy
- at least 1 measurable lesion on imaging.
- must have received adequate prior therapy for the underlying CD20+ B-cell lymphoma, defined as an anti-CD20 mAb in combination with an anthracycline-containing chemotherapy regimen (i.e. chemo-immunotherapy) and at least one of the following:
Key exclusion criteria (13 listed)
- known active central nervous system (CNS) involvement by malignancy.
- prior treatment as follows:
- clinically significant cardiac disease
- clinically significant active infection
- clinically significant CNS disorder
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 |
|---|---|---|
| ACTR707autologous T cell product | Biological | ACTR707 in combination with rituximab |
| rituximabCD20-directed cytolytic antibody | Biological | ACTR707 in combination with rituximab |
Primary outcome
Safety as assessed by dose limiting toxicities (DLTs)
Time frame: 28 days
Dose-limiting toxicities, MTD, incidence and severity of AEs and clinically significant abnormalities of laboratory values
Determination of maximum tolerated dose and proposed recommended Phase 2 dose
Time frame: 24 weeks
8 secondary outcomes
Anti-lymphoma activity as measured by overall response rate
Time frame: 24 weeks
Anti-lymphoma activity as measured by duration of response
Time frame: 24 weeks
Anti-lymphoma activity as measured by progression-free survival
Time frame: 24 weeks
Anti-lymphoma activity as measure by overall survival
Time frame: 24 weeks
Assessment of persistence of ACTR707 as measured by flow cytometry and qPCR
Time frame: 24 weeks
Assessment of ACTR707 phenotype and function as measured by flow cytometry
Time frame: 24 weeks
Assessment of inflammatory markers and cytokines/chemokines
Time frame: 24 weeks
Rituximab PK
Time frame: 24 weeks
Results and safety
The study was stopped early (reason given: Business decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2021.
- Derived from this study: PubMed 34515338Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2.
- 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.
Jessica Sachs, MD study director
Cogent Biosciences, Inc.
11 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 ACTR707 and rituximab in people with Lymphoma, run by Cogent Biosciences, Inc. at 11 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 13 inclusion and 13 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: stopped early, as of the sponsor's last update on 11 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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 was stopped early (reason given: Business decision). Results are not available in the source record.
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?
Safety as assessed by dose limiting toxicities (DLTs) (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03189836, which also lists 1 linked publication.
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 11 Oct 2021.