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Engineered t cells take on lymphoma in early trial

NCT ID NCT02917083

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase study tests a new treatment for people with Hodgkin or non-Hodgkin lymphoma that has returned or not responded to standard therapy. The treatment uses the patient's own T cells, which are genetically modified to recognize and attack cancer cells carrying the CD30 protein. Up to 60 participants will receive one infusion of these CD30 CAR T cells after chemotherapy to make room for the cells to grow. The main goal is to check safety and find the best dose.

What this could mean

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

Active substance
CD30 CAR T cells (genetically modified immune cells)
What this could lead to
If this works, it could point toward a new treatment option for people with lymphoma that has come back after other treatments.
What could go wrong
This is a very early Phase 1 trial with only 60 people, focused on safety. The cells may not last long in the body, and it is unknown if they will effectively fight the cancer.

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

About 60 people

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

Started

May 2017

Expected to finish

Feb 2040

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.

PROCUREMENT Inclusion Criteria: 1. Diagnosis of relapsed/refractory HL or NHL. 2. CD30 positive tumor as assayed in a CLIA certified pathology laboratory (result can be pending at this time) 3. Hgb ≥ 7.0 (may be a transfused value) 4. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent. 5. Karnofsky or Lansky score of \> 60% TREATMENT Inclusion Criteria: 1. Diagnosis of relapsed/refractory HL or NHL. 2. CD30-positive tumor as assayed in a CLIA certified pathology laboratory. 3. Age 16 to 75 for the first three patients on a dose level; thereafter, if no DLT, patients aged 12 to 75 can be treated on that dose level. 4. Bilirubin 1.5 times 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 autologous T cells with greater than or equal to 15% expression of CD30CAR determined by flow-cytometry. 11. Recovered from all acute non-hematologic toxic effects of all prior chemotherapy. 12. Adequate pulmonary function with FEV1, FVC and DLCO (or DLCO/VA, as clinically appropriate) greater than or equal to 50% of expected corrected for hemoglobin. 13. 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. 14. Informed consent explained to, understood by and signed by patient or guardian. PROCUREMENT Exclusion Criteria: 1. Active infection with HIV or HTLV (can be pending at this time). 2. Active bacterial, fungal or viral infection. TREATMENT Exclusion Criteria: 1. Currently receiving any investigational agents or received any tumor vaccines within the previous six weeks. 2. Received anti-CD30 antibody-based therapy within the previous 4 weeks. 3. Subjects with rapidly progressive disease, defined as kinetic failure to previous chemotherapy. 4. Bulky disease (defined as a 10 cm or greater mass or mediastinal disease with a transverse diameter exceeding 33% of the transthoracic diameter). 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. 8. Current use of systemic corticosteroids at a dose equivalent to 0.5 mg/kg/day of prednisone or higher. 9. Active hemorrhagic cystitis. 10. Active bacterial, viral or fungal infection. 11. 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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Houston Methodist Hospital

    RECRUITING

    Houston, Texas, 77030, United States

  • Texas Children's Hospital

    RECRUITING

    Houston, Texas, 77030, United States

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