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LymphomaPhase 1NCT02776813

Study of ACTR087 in Subjects With Relapsed or Refractory B-cell Lymphoma

A Phase 1 study testing ACTR087 and rituximab in people with Lymphoma, run by Cogent Biosciences, Inc. at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a phase 1, multi-center, single-arm, open-label study evaluating the safety and efficacy of an autologous T-cell product expressing ACTR 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 75 years
Conditions the study is for
Lymphoma
What is being tested?
ACTR087 and rituximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
7 sitesUnited States
Study dates
Aug 2016to 12 Feb 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 75 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
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  • TH-FL
  • Biopsy-confirmed CD20+ expression of the underlying malignancy by immunohistochemical staining or flow cytometry between the most recent dose of an anti-CD20 monoclonal antibody (mAb) and study enrollment
  • At least 1 measurable lesion on imaging. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy
  • 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
  • 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 PCR): relapsed or refractory disease after at least 1 prior regimen with chemo-immunotherapy (prior auto-HSCT is allowable)
  • Karnofsky performance scale ≥ 60%
  • Life expectancy of at least 6 months
  • ANC > 1000/µL
  • Platelet count > 50,000/µL
  • For women of childbearing potential (defined as physiologically capable of becoming pregnant), agreement to use of highly effective contraception for at least 1 year following ACTR087 infusion. For men with partners of childbearing potential, agreement to use effective barrier contraception for at least 1 year following ACTR087 infusion

Who cannot join

  • Known active central nervous system (CNS) involvement by malignancy. Subjects with prior CNS involvement with their lymphoma must have completed effective treatment of their CNS disease at least 3 months prior to enrollment with no evidence of disease clinically and at least stable findings on relevant CNS imaging
  • 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
  • Serum creatinine ≥ 1.5 X age-adjusted upper limits of normal (ULN)
  • Pulse oximetry < 92% on room air
  • Direct bilirubin ≥ 3.0 mg/dL (50 mmol/L)
  • Alanine transaminase (ALT) ≥ 3 times the ULN, unless determined to be directly due to lymphoma.
  • Aspartate transaminase (AST) ≥ 3 times the ULN, unless determined to be directly due to lymphoma
  • Class III or IV heart failure as defined by the New York Heart Association (NYHA), history of cardiac angioplasty or stenting, documented myocardial infarction or unstable angina within 6 months prior to enrollment, cardiac ejection fraction of < 45%, or other clinically significant cardiac disease
  • Clinical history of, prior diagnosis of, or overt evidence of autoimmune disease, regardless of severity
  • Clinically significant active infection, in the judgment of the investigator
  • Pregnancy (negative serum pregnancy test to be obtained within 6 days prior to enrollment for subjects of childbearing potential)
  • Breastfeeding
  • Primary immunodeficiency
  • Seropositive for Human Immunodeficiency Virus (HIV) 1 or HIV 2, or positive hepatitis B surface antigen (HBsAg) or hepatitis C antibody
  • Will need or has needed active treatment of a second malignancy within the prior 3 years before enrollment, other than FL, non-melanoma skin cancers, localized prostate cancer treated with curative intent, or cervical carcinoma in situ
  • Is unable to receive any of the agents used in this study due a history of severe immediate hypersensitivity reaction (e.g. hypersensitivity to dimethyl sulfoxide (DMSO))
  • History of prior allogeneic HSCT
  • History of Richter's transformation from CLL
  • Prior infusion of a genetically modified therapy

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Ohio State University

    Columbus, Ohio, 43210

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

  • Indiana Bone and Marrow Transplantation

    Indianapolis, Indiana, 46237

  • Loyola University Chicago

    Maywood, Illinois, 60153

  • Yale University

    New Haven, Connecticut, 06520

Other trials in United States

About this study

Official title: Phase 1 Study of ACTR087, Autologous T Lymphocytes Expressing Antibody Coupled T-cell Receptors (CD16V-41BB-CD3ζ), in Combination With Rituximab, in Subjects With Relapsed or Refractory CD20-Positive B-Cell Lymphoma

This is a phase 1, multi-center, single-arm, open-label study evaluating the safety and efficacy of an autologous T-cell product expressing ACTR in combination with rituximab in subjects with refractory or relapsed CD20+ B-cell lymphoma.

Conditions
Lymphoma
Being tested
ACTR087, rituximab
Keywords
CD20+, B-cell, ACTR087, Relapsed, Refractory
Medical subject headings
Lymphoma, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02776813
Study groupRoleWhat they receive
ACTR087, in combination with rituximabExperimentalNot described
Receives: Biological: ACTR087; Biological: rituximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety as assessed by dose limiting toxicities (DLTs)

    Measured: 28 days

  2. Safety as assessed by determination of the maximum tolerated dose (MTD)

    Measured: 24 months

  3. Safety as assessed by determination of the recommended phase 2 dose (RP2D)

    Measured: 24 months

  4. Safety as assessed by and adverse events, laboratory assessments and physical examinations

    Measured: 24 months

  5. Safety as assessed by mini-mental state examination (MMSE)

    Measured: 24 months

Secondary outcomes (4)

  1. Overall response rate

    Measured: 24 months

  2. Duration of response

    Measured: 24 months

  3. Progression free survival

    Measured: 24 months

  4. Overall survival

    Measured: 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2016 (estimated)
  2. Study startAug 2016
  3. Primary completion12 Feb 2020
  4. Study completion12 Feb 2020

Resources

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
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02776813
Sponsor's protocol ID
UT-201501
Other IDs
ATTCK-20-2
Status last verified
Mar 2020
First submitted
4 May 2016
Last updated
31 Mar 2020
Results posted
No
Data monitoring committee
Yes
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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ACTR087 and rituximab in people with Lymphoma, run by Cogent Biosciences, Inc. at 7 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 25 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 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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?

Safety as assessed by dose limiting toxicities (DLTs) (time frame: 28 days). The study lists 5 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 NCT02776813, 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 31 Mar 2020.

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