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Engineered donor cells take on lymphoma in early trial

NCT ID NCT04288726

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 27, 2026 · Updated 5 times

Summary

This early-phase study tests a new approach for patients with certain lymphomas (Hodgkin, NK/T-cell, and others) that have returned or not responded to treatment. The therapy uses immune cells from healthy donors that are specially trained in the lab to attack cancer cells carrying a protein called CD30, and also to target the Epstein-Barr virus if present. The main goals are to find the safest dose and to see if the treatment can shrink tumors.

What this could mean

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

Active substance
donor immune cells (T cells) engineered to recognize CD30 and Epstein-Barr virus
What this could lead to
If it works, this could offer a new treatment option for patients with lymphomas that have not responded to standard therapy.
What could go wrong
This is a very early phase 1 trial with only 18 participants, so it is not yet known if the treatment is safe or effective. There are risks of serious side effects, including allergic reactions and graft-versus-host disease.

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.

Participants

27 people

The number who actually took part.

Started

Sep 2020

Expected to finish

Jun 2037

An estimate. End dates often move.

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

12 to 75 years

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. Diagnosis and clinical course falling into one of the following categories: 1. Hodgkin lymphoma 2. Aggressive non-Hodgkin lymphoma 3. ALK-negative anaplastic T cell lymphoma or other peripheral T-cell lymphoma 4. ALK-positive anaplastic T cell lymphoma 2. CD30-positive tumor as assayed in a CLIA certified Pathology Laboratory. 3. Age 12 to 75. 4. Bilirubin 2 times (or 3 times if the patient has Gilbert syndrome) or less than the upper limit of normal. 5. AST 3 times or less than the upper limit of normal. 6. Estimated GFR \> 70 mL/min. 7. Pulse oximetry of \> 90% on room air 8. EKG shows no significant arrhythmias 9. Karnofsky or Lansky score of \> 60%. 10. Available allogeneic T cells with ≥15% expression of CD30CAR determined by flow-cytometry. 11. Recovered from all acute non-hematologic toxic effects of all prior chemotherapy. 12. Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after the study is concluded. The male partner should use a condom. 13. Informed consent explained to, understood by and signed by patient or guardian. Patient or guardian given a copy of the informed consent form. Exclusion Criteria: 1. Received an investigational cell therapy or vaccine within the past 6 weeks. 2. Received an investigational small molecule drug within the past 2 weeks. 3. Received CD30 antibody-based therapy within the previous 4 weeks. 4. Received gemcitabine-containing chemotherapy within the previous 12 weeks 5. History of hypersensitivity reactions to murine protein-containing products. 6. Pregnant or lactating. 7. Tumor in a location where enlargement could cause airway obstruction (determined at the investigators' discretion). 8. Current use of systemic corticosteroids at a dose equivalent to higher than 10 mg/day of prednisone. 9. Active significant, uncontrolled bacterial, viral or fungal infection. 10. Symptomatic cardiac disease (NYHA Class III or IV disease).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Houston Methodist Hospital

    Houston, Texas, 77030, United States

  • Texas Children's Hospital

    Houston, Texas, 77030, United States

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Other studies related to the condition(s) this trial covers.