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Supercharged immune cells aim to stop lymphoma comeback

NCT ID NCT02663297

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase trial tests a new treatment for people with Hodgkin or non-Hodgkin lymphoma who have had a stem cell transplant. The treatment uses the patient's own T cells, which are modified in a lab to recognize and attack cancer cells that carry a protein called CD30. The main goal is to find a safe dose and see if these engineered cells can prevent the cancer from coming back.

What this could mean

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

Active substance
ATLCAR.CD30 cells (engineered T cells that target CD30 on lymphoma cells)
What this could lead to
If successful, this approach could help prevent lymphoma from returning after a stem cell transplant, offering a new way to keep the cancer in check.
What could go wrong
This is an early phase 1 trial with only 18 participants, so it is primarily testing safety and dosing. The treatment may not work as hoped, and side effects like cytokine release syndrome are possible.

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

18 people

The number who actually took part.

Started

Jun 2016

Expected to finish

Jan 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

3 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: * Informed consent explained to, understood by and signed by patient/guardian; patient/guardian given copy of informed consent. * 3 to 17 years of age for pediatric patients, ≥18 years of age for adults; NOTE: children will not be allowed to enroll in a dose cohort until a minimum of 2 adult subjects are enrolled and complete their DLT assessment follow-up at that dose level * Diagnosis of recurrent HL with a treatment plan that will include high dose chemotherapy with/without total body irradiation and autologous cell transplantation * NHL patients with ALK negative CD30+ anaplastic large-cell lymphomas, CD30+ ALCL regardless of ALK status, with chemotherapy-sensitive relapse, CD30+ high-risk DLBCL, CD30+ cutaneous T cell lymphoma, or CD30+ mycosis fungoides who are otherwise eligible for transplant, are eligible for this study * CD30+ disease (result can be pending at the time of cell procurement, but must be confirmed prior to treatment with ATLCAR.CD30 cells); NOTE: CD30 + disease is defined as requiring documentation of CD30 expression by immunohistochemistry based on the institutional hematopathology standard. * Evidence of adequate organ function as defined by: * The following is required prior to procurement (NOTE: labs do not need to be redrawn if they have already been performed as part of SOC pre-transplant work-up; Subject must be eligible to receive ASCT) * Hgb ≥ 8.0g/dL * Bilirubin ≤1.5 times the upper limit of normal (ULN) * AST ≤ 3 times ULN * Serum creatinine ≤1.5 times ULN * Cardiac and pulmonary function that is adequate for ASCT * The following is required prior to infusion of ATLCAR.CD30 cells: * Absolute neutrophil count (ANC) ≥500 cells/mm\^3 for 3 consecutive days; Note: ANC may be measured at the beginning and the end of a time frame expanding at least 3 days and does not need to be evaluated on each individual day AND * Platelet count ≥25,000 cells/mm\^3 without transfusion over preceding 5 days Note: Platelets may be measured at the beginning and the end of a time frame expanding at least 5 days and does not need to be evaluated on each individual day AND * Hg ≥8g/dL without transfusion support over preceding 5 days Note: Hg may be measured at the beginning and the end of a time frame expanding at least 3 days and does not need to be evaluated on each individual day * Bilirubin ≤1.5 times the upper limit of normal (ULN) * AST ≤ 3 times ULN * Serum creatinine ≤1.5 times ULN * Pulse oximetry of \> 90% on room air * Imaging results from within 60 days prior to transplant (used as baseline measure for documentation of disease status). Note: Results may be obtained at a time point greater than 30 days from transplant if obtained per the patient's standard of care and with prior sponsor approval. * Negative serum pregnancy test within 72 hours prior to procurement and again 72 hours prior to infusion * Karnofsky or Lansky score of \> 60% * Considered at high risk for relapse as defined by: The presence of ≥ 1 of the following: failure to achieve CR post initial treatment; relapsed disease with an initial remission duration of \<12 months; or extranodal involvement at the start of pre-transplant salvage therapy * Subjects must have autologous transduced activated T cells that meet the Certificate of Analysis (CoA) acceptance criteria * Women of childbearing potential (WOCBP) should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study, and for 6 months after the study is concluded. WOCBP are those who have not been surgically sterilized or have not been free from menses for \> 1 year. The two birth control methods can be composed of: two barrier methods or a barrier method plus a hormonal method to prevent pregnancy. The male partner of WOCBP subjects enrolled into the trial should be instructed to use a condom by their female partner enrolled in the trial. Exclusion Criteria: * Received any investigational agents or received any tumor vaccines within the previous six weeks prior to cell infusion. * Received anti-CD30 antibody-based therapy within the previous 4 weeks prior to cell infusion * History of hypersensitivity reactions to murine protein-containing products * Pregnant or lactating * Tumor in a location where enlargement could cause airway obstruction. * Current use of systemic corticosteroids at doses ≥10mg/day prednisone or its equivalent; those receiving \<10mg/day may be enrolled at discretion of investigator * Active infection with HIV, HTLV, HBV, HCV (can be pending at the time of cell procurement; only those samples confirming lack of active infection will be used to generate transduced cells) . Active infection is defined as not being well controlled on therapy (Note: To meet eligibility subjects are required to be negative for HIV antibody or HIV viral load, negative for HTLV1 and 2 antibody, negative for Hepatitis B surface antigen, or negative for HCV antibody or HCV viral load).

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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

  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina, 27599, United States

  • Wake Forest University

    Winston-Salem, North Carolina, 27157, United States

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