EBV CTLs Expressing CD30 Chimeric Receptors For CD 30+ Lymphoma

NCT01192464 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: H-26617 CAR CD 30
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

Brief Summary

The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancer. This research study combines two different ways of fighting disease: antibodies and T cells. Antibodies are proteins the protect the body from diseases caused by germs or toxic substances. They work by binding those germs or substances, which stops them from growing and causing bad effects. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including tumor cells or cells that are infected with germs. Both antibodies and T cells have been used to treat patients with cancers: they both have been shown promise, but have not been strong enough to cure most patients. This study combines the two methods. We have found from previous research that we can put a new gene into T cells that will make them recognize cancer cells and kill them. We now want to see if we can attach a new gene to T cells that will help them do a better job at recognizing and killing lymphoma cells. The new gene we will put in T cells makes an antibody called anti-CD30. The antibody alone has not been strong enough to cure most patients. For this study, the anti-CD30 antibody has been changed so that instead of floating free in the blood it is now joined to the T cells. When an antibody is joined to a T cell in this way it is called a chimeric receptor. These chimeric receptor-T cells seem to kill some of the tumor, but they don't last very long and so their chances of fighting the cancer are unknown. We have found that T cells that are also trained to recognize the EBV virus (that causes infectious mononucleosis) can stay in the blood stream for many years. These are called EBV specific Cytotoxic T Lymphocytes. By joining the anti-CD30 antibody to the EBV CTLs, we believe that we will also be able to make a cell that can last a long time in the body and recognize and kill lymphoma cells. We call the final cells CD30 chimeric receptor EBV CTLs. T We hope that these new cells may be able to work longer and target and kill lymphoma cells. However, we do not know that yet.

Conditions

Hodgkin's Lymphoma; Non-Hodgkin's Lymphoma

Keywords

Hodgkin's Lymphoma; Non-Hodgkin's Lymphoma

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety of escalating doses of autologous EBV-specific cytotoxic T-lymphocytes (CTLs),

  To evaluate the safety of escalating doses of autologous EBV-specific cytotoxic T-lymphocytes (CTLs), genetically modified to express an artificial T-cell receptor (CAR) targeting the CD30 molecule (CAR.CD30), in patients with CD30+ refractory/relapsed Hodgkin lymphoma (HL) or non-Hodgkin lymphoma (NHL)

  6 weeks

Secondary Outcomes (2)

• To measure the survival of CAR.CD30 transduced EBV-CTLs in vivo.

  15 years

• To measure the anti-tumor effects of CAR.CD30 transduced CTLs

  8 weeks

Study Arms (1)

autologous CAR.CD30 EBV specific-CTLs

EXPERIMENTAL

Group One Dose (CTLs CAR.CD30) at Day 0: 2x10\^7 cells/m2 Group Two Dose (CTLs CAR.CD30) at Day 0: 5x10\^7 cells/m2 Group Three Dose (CTLs CAR.CD30) at Day 0: 1x10\^8 cells/m2

Drug: autologous CAR.CD30 EBV specific-CTLs

Interventions

autologous CAR.CD30 EBV specific-CTLs DRUG

Three dose levels will be evaluated. Using the modified continual reassessment method, cohorts of size two will be enrolled at each dose level. Each patient will receive one injection.

Also known as: CD30 EBV CTL

autologous CAR.CD30 EBV specific-CTLs

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Referred patients will initially be consented for procurement of blood for generation of the transduced CTL Line. Eligibility criteria at this stage include:
• Diagnosis of recurrent HL or NHL, or newly diagnosed patients unable to receive or complete standard therapy OR diagnosis of relapsed/refractory HL or NHL with a treatment plan that will include high dose therapy and stem cell transplantation
• CD30 positive tumor (can be pending at this time)
• EBV seropositivity (can be pending at this time)
• Hgb \> 8.0
• Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.
• Diagnosis - CD30+ HL or CD30+ NHL
• During the dose escalation phase: only adult patients (age 18 and older) with active disease failing standard therapy
• After dose escalation: any patient (children or adults) with relapsed CD30+ HL or CD30+ NHL or newly diagnosed patients unable to receive or complete standard therapy OR diagnosis of relapsed/refractory CD30+ HL or CD30+ NHL with a treatment plan that will include high dose therapy and autologous stem cell transplantation.
• CD30 positive tumor
• EBV seropositivity.
• Recovered from acute toxic effects of all prior chemotherapy at least one week and 30 days from prior chemotherapy before entering this study.
• Bilirubin 1.5 times or less than upper limit of normal.
• AST 3 times or less than upper limit of normal.
• Serum creatinine 1.5 times or less than upper limit of normal.

You may not qualify if:

• Active infection with HIV, HTLV, HBV, HCV (can be pending at this time).
• Received rituximab within 4 months of blood collection for LCL initiation (unless circulating CD19+ B are =/\>2%)
• Currently receiving any investigational agents or received any tumor vaccines within the previous six weeks.
• Received anti-CD30 antibody-based therapy within the previous 6 weeks.
• 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead
• Center for Cell and Gene Therapy, Baylor College of Medicine: collaborator
• The Methodist Hospital Research Institute: collaborator

Study Sites (2)

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Hodgkin Disease; Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Helen E Heslop, MD

  Baylor College of Medicine/Center for Cell and Gene Therapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 16, 2010
• First Posted: September 1, 2010
• Study Start: May 10, 2011
• Primary Completion: May 29, 2012
• Study Completion (Estimated): October 1, 2033
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

US (2)