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Engineered immune cells take on Hard-to-Treat lymphoma

NCT ID NCT04245839

Disease control Sponsor: Celgene Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial is testing an experimental cell therapy called JCAR017 for adults with relapsed or refractory indolent B-cell non-Hodgkin lymphoma, specifically follicular or marginal zone lymphoma. Participants receive chemotherapy followed by a single infusion of their own genetically modified immune cells. The study aims to see how many patients respond and how long the response lasts, with follow-up for up to 5 years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
JCAR017 (a CAR T-cell therapy) given after lymphodepleting chemotherapy with fludarabine and cyclophosphamide
What this could lead to
If successful, this could offer a new treatment option for people with certain slow-growing lymphomas that have not responded to standard therapies.
What could go wrong
This is a mid-stage trial without a comparison group, so results are preliminary. CAR T-cell therapies can cause serious side effects like cytokine release syndrome and neurological problems.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 276 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2020

Expected to finish

Sep 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Relapsed or refractory follicular lymphoma (FL) (Grade 1, 2 or 3a) or marginal zone lymphoma (MZL) histologically confirmed within 6 months of screening, as assessed by local pathology 2. Patients should have received at least one prior therapy that includes anti-CD20 and alkylating agent 3. Follicular lymphoma patients: Received at least one prior line of systemic therapy. Patients that received one prior line of systemic therapy are eligible if they present with high risk features. Patients that received two or more prior lines of systemic therapy are eligible, assuming one of the prior lines includes anti-CD20 and alkylating agent (as listed in criterion 2) 4. Marginal zone lymphoma patients: Received two or more prior lines of systemic therapy, assuming one of the prior lines includes anti-CD20 and alkylating agent (as listed in criterion 2) or relapsed after hematopoietic stem cell transplant 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 6. Adequate organ function 7. Adequate vascular access for leukapheresis procedure Exclusion Criteria: 1. Evidence or history of composite Diffuse large B-cell lymphoma (DLBCL) and FL, or of transformed FL 2. WHO subclassification of duodenal-type FL 3. Central nervous system-only involvement by malignancy (subjects with secondary central nervous system (CNS) involvement are allowed on study) 4. History of another primary malignancy that has not been in remission for at least 2 years, with the exception of non-invasive malignancies 5. Prior CAR T-cell or other genetically-modified cell therapy 6. History of or active human immunodeficiency virus (HIV) 7. Active hepatitis B or active hepatitis C 8. Uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate antibiotics or other treatment 9. Active autoimmune disease requiring immunosuppressive therapy 10. Presence of acute or chronic graft-versus-host=disease 11. History of significant cardiovascular disease 12. History or presence of clinically relevant central nervous system pathology 13. Allogenic-hematopoietic stem cell transplant (Allo-HSCT) within 90 days of leukapheresis

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Conditions

The condition(s) this trial relates to.

B-cell neoplasm follicular lymphoma Lymphoma, B-Cell, Marginal Zone lymphoma, non-Hodgkin, familial marginal zone lymphoma non-Hodgkin lymphoma Recurrence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lymphoma, non-Hodgkin

Contacts and locations

Locations

  • Local Institution - 100

    Boston, Massachusetts, 02114, United States

  • Local Institution - 101

    Boston, Massachusetts, 02215, United States

  • Local Institution - 102

    Baltimore, Maryland, 21201, United States

  • Local Institution - 103

    Chicago, Illinois, 60611, United States

  • Local Institution - 104

    Houston, Texas, 77030, United States

  • Local Institution - 105

    New Haven, Connecticut, 06520, United States

  • Local Institution - 107

    Aurora, Colorado, 80045, United States

  • Local Institution - 108

    Seattle, Washington, 98109, United States

  • Local Institution - 109

    Niles, Illinois, 60714, United States

  • Local Institution - 110

    Charlotte, North Carolina, 28204, United States

  • Local Institution - 111

    Santa Monica, California, 90095, United States

  • Local Institution - 112

    Cleveland, Ohio, 44195, United States

  • Local Institution - 113

    Sioux Falls, South Dakota, 57105, United States

  • Local Institution - 114

    Portland, Oregon, 97213, United States

  • Local Institution - 115

    Charlottesville, Virginia, 22903, United States

  • Local Institution - 116

    New York, New York, 10021, United States

  • Local Institution - 117

    Philadelphia, Pennsylvania, 19104, United States

  • Local Institution - 119

    Houston, Texas, 77030, United States

  • Local Institution - 121

    Dallas, Texas, 75230-2510, United States

  • Local Institution - 122

    Iowa City, Iowa, 52242, United States

  • Local Institution - 123

    Morristown, New Jersey, 07960, United States

  • Local Institution - 124

    Wichita, Kansas, 67124, United States

  • Local Institution - 127

    Detroit, Michigan, 48201, United States

  • Local Institution - 150

    Toronto, Ontario, M5G 2M9, Canada

  • Local Institution - 151

    Montreal, Quebec, H1T 2M4, Canada

  • Local Institution - 200

    London, NW1 2PG, United Kingdom

  • Local Institution - 201

    Manchester, M20 4BX, United Kingdom

  • Local Institution - 250

    Pierre-Bénite, 69495, France

  • Local Institution - 251

    Montpellier, 34295, France

  • Local Institution - 252

    Lille, 59037, France

  • Local Institution - 253

    Rennes, 35023, France

  • Local Institution - 254

    Toulouse, 31100, France

  • Local Institution - 255

    Paris, 75475, France

  • Local Institution - 300

    Bergamo, 24127, Italy

  • Local Institution - 301

    Naples, 80131, Italy

  • Local Institution - 350

    Salamanca, 37007, Spain

  • Local Institution - 351

    Seville, 41013, Spain

  • Local Institution - 353

    Madrid, 28007, Spain

  • Local Institution - 450

    Vienna, 1090, Austria

  • Local Institution - 500

    Ulm, Baden-Wurttemberg, 89081, Germany

  • Local Institution - 501

    Cologne, 50937, Germany

  • Local Institution - 502

    Munich, 81377, Germany

  • Local Institution - 503

    Karlsruhe, 76135, Germany

  • Local Institution - 504

    Regensburg, Bavaria, 93053, Germany

  • Local Institution - 550

    Chuo-ku, Tokyo, 1040045, Japan

  • Local Institution - 551

    Minato-ku, Tokyo, 105-8470, Japan

  • Local Institution - 552

    Fukuoka, 812-8582, Japan

  • Local Institution - 553

    Sapporo, Hokkaido, 0608648, Japan

  • Local Institution - 600

    Stockholm, 14186, Sweden

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