Administration of T Lymphocytes for Prevention of Relapse of Lymphomas

Official record

Identifier

NCT02663297

Recruiting locations

country

United States

Interventions studied

ATLCAR.CD30 cells

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Target enrolment

18 participants

Study type

INTERVENTIONAL

Phase

Phase 1

Status

Active, not recruiting

First posted

Jan 26, 2016

Last updated on the registry

Oct 1, 2026

Age

3 Years

Sex

ALL

Study contact

No public contact is listed on the official record.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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).

Indexed under

Lymphoma