A Phase 1/2 interventional study of Autologous Hematopoietic Stem Cell Transplantation and Filgrastim in Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma and Recurrent Grade 3 Follicular Lymphoma, sponsored by City of Hope Medical Center. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by City of Hope Medical Center · Phase 1/2, Interventional, and Treatment
This phase I/II trial studies the side effects and best dose of genetically engineered lymphocyte therapy and to see how well it works after peripheral blood stem cell transplant (PBSCT) in treating patients with high-risk, intermediate-grade, B-cell non-Hodgkin lymphoma (NHL). Genetically engineered lymphocyte therapy may stimulate the immune system in different ways and stop cancer cells from growing. Giving rituximab together with chemotherapy before a PBSCT stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as filgrastim (G-CSF), or plerixafor helps stem cells move from the bone marrow to the blood so they can be collected and stored. More chemotherapy or radiation therapy is given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Giving genetically engineered lymphocyte therapy after PBSCT may be an effective treatment for NHL.
PRIMARY OBJECTIVES:
I. To assess the safety of cellular immunotherapy utilizing ex vivo expanded autologous central memory T cell (TCM)-enriched cluster of differentiation (CD)8+ T cells genetically-modified to express a CD19-specific chimeric antigen receptor (CAR) in conjunction with a standard myeloablative autologous hematopoietic stem cell transplantation (aHSCT) for research participants with high-risk intermediate grade B-lineage non-Hodgkin lymphomas who have relapsed after primary therapy, or who did not achieve complete remission with primary therapy. (Phase I) II. To determine the maximum tolerated dose (MTD) on dose limiting toxicities (DLTs) and to describe the full toxicity profile. (Phase I) III. To determine the rate of research participants receiving TCM-enriched CD8+ T cells genetically-modified to express a CD19-specific CAR for which the transferred cells are detected in the circulation 28 days (+/- 3 days) by woodchuck hepatitis virus post-transcriptional regulatory element (WPRE) quantitative (Q)-polymerase chain reaction (PCR). (Phase II)
SECONDARY OBJECTIVES:
I. To determine the tempo, magnitude, and duration of engraftment of the transferred T cell product as it relates to the number of cells infused. (Phase II) II. To study the impact of this therapeutic intervention on the development of CD19+ B-cell precursors in the bone marrow as a surrogate for the in vivo effector function of transferred CD19-specific T cells. (Phase II) III. To describe the progression-free and overall survival of treated research participants on this protocol. (Phase II)
OUTLINE: This is a phase I, dose-escalation study of genetically engineered lymphocyte therapy followed by a phase II study.
Patients receive standard salvage chemotherapy per standard practice and undergo standard mobilization for stem cell collection with filgrastim and/or plerixafor. Some patients may also receive rituximab intravenously (IV) within 4 weeks of transplant. Patients receive standard myeloablative conditioning followed by autologous PBSCT. Patients then undergo infusion of ex vivo expanded autologous TCM-enriched CD8+ T cells expressing CD19-specific CAR on day 2 or 3 after transplant.
After completion of study treatment, patients are followed up periodically for at least 15 years.
931 studies on the registry are indexed under Lymphoma, Follicular; 237 are open to participants now.
This study's enrollment of 8 is below the median of 48 across 797 interventional studies indexed under Lymphoma, Follicular.
Browse Lymphoma, Follicular studies →City of Hope Medical Center is the lead sponsor of 670 studies on the registry; 181 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 12 (40%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients receive standard salvage chemotherapy per standard practice and undergo standard mobilization for stem cell collection with G-CSF and/or plerixafor. Some patients may also receive rituximab IV within 4 weeks of transplant. Patients receive standard myeloablative conditioning followed by autologous PBSCT. Patients then undergo infusion of ex vivo expanded autologous TCM-enriched CD8+ T cells expressing CD19-specific CAR on day 2 or 3 after transplant.
Procedure: Autologous Hematopoietic Stem Cell Transplantation · Biological: Filgrastim · Biological: Genetically Engineered Lymphocyte Therapy · Other: Laboratory Biomarker Analysis · Procedure: Peripheral Blood Stem Cell Transplantation · Drug: Plerixafor · Biological: Rituximab
Undergo autologous PBSCT
Also known as: AHSCT, Autologous, Autologous Hematopoietic Cell Transplantation, Autologous Stem Cell Transplant, Autologous Stem Cell Transplantation, Stem Cell Transplantation, Autologous
Given IV
Also known as: Filgrastim-aafi, G-CSF, Neupogen, Nivestym, r-metHuG-CSF, Recombinant Methionyl Human Granulocyte Colony Stimulating Factor, rG-CSF, Tevagrastim
Receive ex vivo expanded autologous TCM-enriched CD8+ T cells expressing CD19-specific CAR
Correlative studies
Undergo autologous PBSCT
Also known as: PBPC transplantation, PBSCT, Peripheral Blood Progenitor Cell Transplantation, PERIPHERAL BLOOD STEM CELL TRANSPLANT, Peripheral Stem Cell Support, Peripheral Stem Cell Transplant, Peripheral Stem Cell Transplantation
Given IV
Also known as: AMD 3100, JM-3100, Mozobil, SDZ SID 791
Given IV
Also known as: ABP 798, BI 695500, C2B8 Monoclonal Antibody, Chimeric Anti-CD20 Antibody, CT-P10, IDEC-102, IDEC-C2B8, IDEC-C2B8 Monoclonal Antibody, MabThera, Monoclonal Antibody IDEC-C2B8, PF-05280586, Rituxan, Rituximab ABBS, Rituximab Biosimilar ABP 798, Rituximab Biosimilar BI 695500, Rituximab Biosimilar CT-P10, Rituximab Biosimilar GB241, Rituximab Biosimilar IBI301, Rituximab Biosimilar JHL1101, Rituximab Biosimilar PF-05280586, Rituximab Biosimilar RTXM83, Rituximab Biosimilar SAIT101, Rituximab Biosimilar SIBP-02, rituximab biosimilar TQB2303, rituximab-abbs, RTXM83, Truxima
Number of Participants With Dose Limiting Toxicities (DLTs)
Number of DLTs per dose level are reported. A DLT is defined as: Any grade 3 or higher toxicity, with the exception of expected adverse events; and designated as definitely or probably related (level of attribution) to the infusion of the TCM cells; and occurring within 28 days of T-cell infusion; Any toxicity requiring the use of steroids to ablate side effects attributable to the infusion of the TCM cells, and occurring within 28 days of T-cell infusion; Any toxicity which is a lower grade, but that increases in grade to a grade 3 or higher as a direct result of the TCM, and occurring within 28 days of T-cell infusion; Any grade 2 or greater autoimmune toxicity, and occurring within 28 days of T-cell infusion.
Time frame: Within 28 days of T-cell infusion
Woodchuck Hepatitis Virus Post-transcriptional Regulatory Element (WPRE) Detection Above Background
Peak expansion of WPRE is expressed in CAR copy number/mL of blood is summarized with median and range
Time frame: 28 days post T cell infusion
Number of Days of Quantifiable CD19 CAR Post T-cell Infusion
WPRE persistence of quantifiable CD19 CAR summarized with mean and standard deviation
Time frame: 28 days post T cell infusion
Failure to Engraft
Count of participants who fail to engraft post transplant.
Time frame: Within 21 days post T-cell infusion
Progression-free Survival at 1 Year
Estimated using the Kaplan-Meier methods. Progression is defined using the revised IWG response criteria, as any new lesion or increase by ≥50% of previously involved sites from nadir.
Time frame: Up to 1 year
| Milestone | Dose Level 0 (25 x 10^6 CAR+ T-cells) | Dose Level 1 (50 x 10^6 CAR+ T-cells) | Dose Level 2 (100 x 10^6 CAR+ T-cells) |
|---|---|---|---|
| Started | 1 | 4 | 3 |
| Completed | 1 | 4 | 3 |
| Not completed | 0 | 0 | 0 |
Number of DLTs per dose level are reported. A DLT is defined as: Any grade 3 or higher toxicity, with the exception of expected adverse events; and designated as definitely or probably related (level of attribution) to the infusion of the TCM cells; and occurring within 28 days of T-cell infusion; Any toxicity requiring the use of steroids to ablate side effects attributable to the infusion of the TCM cells, and occurring within 28 days of T-cell infusion; Any toxicity which is a lower grade, but that increases in grade to a grade 3 or higher as a direct result of the TCM, and occurring within 28 days of T-cell infusion; Any grade 2 or greater autoimmune toxicity, and occurring within 28 days of T-cell infusion.
| Participants | Dose Level 0 (25 x 10^6 CAR+ T-cells) | Dose Level 1 (50 x 10^6 CAR+ T-cells) | Dose Level 2 (100 x 10^6 CAR+ T-cells) |
|---|---|---|---|
| Number of Participants With Dose Limiting Toxicities (DLTs) | 0 | 0 | 0 |
Peak expansion of WPRE is expressed in CAR copy number/mL of blood is summarized with median and range
| CAR copy number/mL | Treatment (Cellular Adoptive Immunotherapy Following PBSCT) |
|---|---|
| Woodchuck Hepatitis Virus Post-transcriptional Regulatory Element (WPRE) Detection Above Background | 280 (0 to 925) |
WPRE persistence of quantifiable CD19 CAR summarized with mean and standard deviation
| days | Treatment (Cellular Adoptive Immunotherapy Following PBSCT) |
|---|---|
| Number of Days of Quantifiable CD19 CAR Post T-cell Infusion | 18.25 ± 12.1 |
Count of participants who fail to engraft post transplant.
| Participants | Dose Level 0 (25 x 10^6 CAR+ T-cells) | Dose Level 1 (50 x 10^6 CAR+ T-cells) | Dose Level 2 (100 x 10^6 CAR+ T-cells) |
|---|---|---|---|
| Failure to Engraft | 0 | 0 | 0 |
Estimated using the Kaplan-Meier methods. Progression is defined using the revised IWG response criteria, as any new lesion or increase by ≥50% of previously involved sites from nadir.
| percentage of participants | Treatment (Cellular Adoptive Immunotherapy Following PBSCT) |
|---|---|
| Progression-free Survival at 1 Year | 50 (16 to 84) |
Collected over During and after treatment, up to 38 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dose Level 0 (25 x 10^6 CAR+ T-cells) | 0/1 (0%) | 0/1 (0%) | 1/1 (100%) |
| Dose Level 1 (50 x 10^6 CAR+ T-cells) | 1/4 (25%) | 2/4 (50%) | 4/4 (100%) |
| Dose Level 2 (100 x 10^6 CAR+ T-cells) | 1/3 (33.3%) | 3/3 (100%) | 3/3 (100%) |
| Event | Dose Level 0 (25 x 10^6 CAR+ T-cells) | Dose Level 1 (50 x 10^6 CAR+ T-cells) | Dose Level 2 (100 x 10^6 CAR+ T-cells) |
|---|---|---|---|
| Neoplasms benign, malignant, and unspecified (incl cysts and polyps)- OtherNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/1 | 0/4 | 1/3 |
| StrokeNervous system disorders | 0/1 | 0/4 | 1/3 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 0/1 | 0/4 | 1/3 |
| Atrial fibrillationCardiac disorders | 0/1 | 1/4 | 0/3 |
| Pulmonary edemaRespiratory, thoracic and mediastinal disorders | 0/1 | 1/4 | 0/3 |
| Event | Dose Level 0 (25 x 10^6 CAR+ T-cells) | Dose Level 1 (50 x 10^6 CAR+ T-cells) | Dose Level 2 (100 x 10^6 CAR+ T-cells) |
|---|---|---|---|
| AnemiaBlood and lymphatic system disorders | 1/1 | 4/4 | 3/3 |
| Febrile neutropeniaBlood and lymphatic system disorders | 1/1 | 2/4 | 3/3 |
| Sinus tachycardiaCardiac disorders | 1/1 | 4/4 | 2/3 |
| Abdominal distensionGastrointestinal disorders | 1/1 | 1/4 | 0/3 |
| Abdominal painGastrointestinal disorders | 1/1 | 2/4 | 2/3 |
| ConstipationGastrointestinal disorders | 1/1 | 2/4 | 2/3 |
| DiarrheaGastrointestinal disorders | 1/1 | 4/4 | 3/3 |
| FlatulenceGastrointestinal disorders | 1/1 | 2/4 | 0/3 |
| Mucositis oralGastrointestinal disorders | 1/1 | 3/4 | 2/3 |
| NauseaGastrointestinal disorders | 1/1 | 4/4 | 3/3 |
| Age, Continuous(years) | Dose Level 0 (25 x 10^6 CAR+ T-cells) | Dose Level 1 (50 x 10^6 CAR+ T-cells) | Dose Level 2 (100 x 10^6 CAR+ T-cells) | Total |
|---|---|---|---|---|
| Median | 75 (NA to NA) | 60 (50 to 69) | 58 (57 to 65) | 62 (50 to 75) |
| Sex: Female, Male(Participants) | Dose Level 0 (25 x 10^6 CAR+ T-cells) | Dose Level 1 (50 x 10^6 CAR+ T-cells) | Dose Level 2 (100 x 10^6 CAR+ T-cells) | Total |
|---|---|---|---|---|
| Female | 0 | 3 | 1 | 4 |
| Male | 1 | 1 | 2 | 4 |
| Ethnicity (NIH/OMB)(Participants) | Dose Level 0 (25 x 10^6 CAR+ T-cells) | Dose Level 1 (50 x 10^6 CAR+ T-cells) | Dose Level 2 (100 x 10^6 CAR+ T-cells) | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 1 | 4 | 3 | 8 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Dose Level 0 (25 x 10^6 CAR+ T-cells) | Dose Level 1 (50 x 10^6 CAR+ T-cells) | Dose Level 2 (100 x 10^6 CAR+ T-cells) | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 |
| White | 1 | 4 | 3 | 8 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Dose Level 0 (25 x 10^6 CAR+ T-cells) | Dose Level 1 (50 x 10^6 CAR+ T-cells) | Dose Level 2 (100 x 10^6 CAR+ T-cells) | Total |
|---|---|---|---|---|
| United States | 1 | 4 | 3 | 8 |
| Disease histology(Participants) | Dose Level 0 (25 x 10^6 CAR+ T-cells) | Dose Level 1 (50 x 10^6 CAR+ T-cells) | Dose Level 2 (100 x 10^6 CAR+ T-cells) | Total |
|---|---|---|---|---|
| Diffuse Large B-Cell Lymphoma | 1 | 3 | 3 | 7 |
| Mantle Cell Lymphoma | 0 | 1 | 0 | 1 |
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