Suspended

Xcellerated T Cells for Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma

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What is being tested

Data Collection

Who is being recruted

Hemic and Lymphatic Diseases+6

+ Immune System Diseases

+ Immunoproliferative Disorders

Over 18 Years
+30 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: March 2004
See protocol details

Summary

Principal SponsorXcyte Therapies
Study ContactVicki M. Mizuno
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2004

Actual date on which the first participant was enrolled.

This study focuses on a new T cell immunotherapy treatment, Xcellerated T CellsTM, for patients with a type of cancer called indolent non-Hodgkin's lymphoma (NHL). The study is designed for patients whose disease has returned or has not responded well to previous treatments, which were no more than four. The main goal of this research is to see if Xcellerated T CellsTM can boost the body's immune response to fight the cancer effectively. This is important because it could potentially offer a new treatment option for patients with this condition. During the study, patients will receive Xcellerated T CellsTM, which are their own T cells that have been activated and multiplied in a lab. The study aims to evaluate the effectiveness and safety of this treatment in these patients. It will also look at changes in the number and type of T- and B-lymphocytes, T cell receptor repertoire, hemoglobin levels, platelet counts, and immunoglobulin levels. In some patients, small samples from malignant lymph nodes and bone marrow will be taken to assess changes in lymphocyte composition and type. Additionally, anti-tumor immune responses will be evaluated in patients who can undergo biopsy of enlarged lymph nodes.

Official TitleA Phase II Study of Xcellerated T CellsTM in Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma (NHL)
Principal SponsorXcyte Therapies
Study ContactVicki M. Mizuno
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Hemic and Lymphatic DiseasesImmune System DiseasesImmunoproliferative DisordersLymphatic DiseasesLymphomaLymphoma, Non-HodgkinLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic Type

Criteria

17 inclusion criteria required to participate
Serum creatinine ≤ 2.0 mg/dL

Serum total bilirubin and alanine aminotransferase (ALT) ≤ 2.0 times the upper limit of normal

Indolent non-Hodgkin's Lymphoma (NHL), with one of the following subtypes according to the REAL Classification: follicular lymphoma, small lymphocytic lymphoma (SLL), extranodal marginal zone B-cell lymphoma (MALT), nodal marginal zone B-cell lymphoma (monocytoid B-cell lymphoma), splenic marginal zone lymphoma (splenic lymphoma with villous lymphocytes) and mantle cell lymphoma. Other subtypes require approval of the Medical Monitor. At least 16 patients with small lymphocytic lymphoma, and no more than eight patients with mantle cell lymphoma will be enrolled.

Stage III or IV disease at any time in the past

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13 exclusion criteria prevent from participating
Evidence of Hodgkin's lymphoma, Burkitt's lymphoma, diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, lymphoplasmacytic lymphoma, hairy cell leukemia, primary central nervous system lymphoma or any other aggressive lymphoma

Any T cell lymphoma

Evidence of primary cutaneous anaplastic large cell lymphoma, Richter's Syndrome, large granular lymphocytosis and Sézary-cell leukemia. Patients with a prior diagnosis of chronic lymphocytic leukemia, as evidenced by absolute peripheral lymphocyte count of greater than 5,000 per mm3 at any time in the past, are not eligible.

Leukemic manifestations of non-Hodgkin's lymphoma. Small lymphocytic lymphoma patients with peripheral lymphocyte count greater than 5,000 per mm3

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Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 18 locations

Recruiting

California Cancer Care

Greenbrae, United StatesOpen California Cancer Care in Google Maps
Recruiting

University of California, San Diego

San Diego, United States
Recruiting

Sharp Memorial Hospital

San Diego, United States
Recruiting

University of California, San Francisco

San Francisco, United States
Suspended18 Study Centers