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Can a second CAR T-Cell infusion beat lymphoma that returns?

NCT ID NCT04419909

Cure Sponsor: University of Pennsylvania 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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time

Summary

This early-stage trial is testing whether a second infusion of a patient's own genetically modified immune cells (CAR T-cells) can safely treat B-cell lymphoma that has returned after an initial successful response. The study enrolls people with diffuse large B-cell or follicular lymphoma whose cancer came back at least six months after their first CAR T-cell treatment. The main goal is to check safety, with a secondary look at whether the cancer shrinks or disappears.

What this could mean

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

Active substance
a second infusion of the patient's own genetically modified immune cells (CAR T-cells) targeting CD19
What this could lead to
If it works, this could offer a second chance at remission for people whose lymphoma returns after an initial CAR T-cell success.
What could go wrong
This is a very early, small Phase 1 safety trial, so it is unclear whether retreatment will be effective or safe. Side effects from CAR T-cells can be severe, including 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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Expected to start

May 2026

An estimate. Start dates often move.

Finished

Jul 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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. Diffuse Large B-Cell Lymphoma or Follicular lymphoma, previously identified as CD19+ 2. Previously treated on UPCC13413/ NCT02030834 with CTL019/CTL119, with historical manufactured product available at Penn for reinfusion 3. Previous complete response to CAR T-cells with a duration ≥ 6 months (defined as 168 days) 4. No available curative treatment options (such as autologous or allogeneic HSCT) with limited prognosis (several months to \< 2 year survival) with currently available therapies. 5. Age ≥18 years 6. Creatinine \< 1.6 mg/dL 7. ALT/AST \< 3x upper limit of normal 8. Bilirubin \< 2.0 mg/dL, unless subject has Gilbert's Syndrome (≤3.0 mg/dL) 9. Measurable or assessable disease according to the "Revised Response Criteria for Malignant Lymphoma" (Cheson et al., J. Clin. Onc., 2007)88. Patients in complete remission with no evidence of disease are not eligible. 10. Performance status (ECOG) 0 or 1. 11. Left Ventricle Ejection Fraction (LVEF) \> 40% confirmed by ECHO/MUGA 12. Agree to contraceptive requirements outlined in Section 4.3. 13. Provide written informed consent. Exclusion Criteria: 1. Uncontrolled active infection. 2. Active hepatitis B or hepatitis C infection. 3. Any uncontrolled active medical disorder that would preclude participation as outlined. 4. Class III/IV cardiovascular disability according to the New York Heart Association Classification (see Appendix 1). 5. HIV infection. 6. Patients with active CNS involvement by malignancy. Patients with prior CNS disease that has been effectively treated will be eligible providing treatment was \>4 weeks before enrollment 7. Patients with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system.

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Conditions

The condition(s) this trial relates to.

B-cell neoplasm diffuse large B-cell lymphoma follicular lymphoma

As listed by the trial registrant

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

Lymphoma, B-cell

Contacts and locations

Locations

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

More trials for these conditions

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