Study of IMPT-314 in R/R Aggressive B-cell
a study on Hodgkin's Lymphoma Lymphoma Non-Hodgkin Lymphoma
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at UCLA
- Dates
- study startedestimated completion
- Principal Investigator
- by Sara M. Larson (ucla)
Description
Summary
This is a Phase 1/2, multi-center, open-label study evaluating the safety and efficacy of IMPT-314, a bispecific chimeric antigen receptor (CAR) targeting cluster of differentiation (CD)19 and CD20 in participants with aggressive B-cell NHL.
Up to 30 patients will be enrolled in dose finding Phase 1 part of the study, which will determine the recommended phase 2 dose.
Phase 2 will enroll 20 additional participants to evaluate further the safety and efficacy of IMPT-314.
IMPT-314 treatment consists of a single infusion of CAR-transduced autologous T cells administered intravenously after a conditioning chemotherapy regimen consisting of fludarabine and cyclophosphamide, administered over 3 days.
Individual participants will remain in the active post-treatment period for approximately 2 years. Participants will continue in long-term follow-up for 15 years from treatment.
Official Title
A Phase 1/2 Multi-center Study Evaluating the Safety and Efficacy of IMPT-314, a CD19/20 Bispecific Chimeric Antigen Receptor (CAR) T Cell Therapy in Participants With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin Lymphoma
Keywords
Relapsed Non-Hodgkin Lymphoma, Refractory Non-Hodgkin Lymphoma, CAR T-cell, Non-Hodgkin Lymphoma, CD19/20, CD19, CD20, NHL, Diffuse Large B-cell lymphoma, DLBCL, Transformed follicular lymphoma, TFL, Primary mediastinal B-cell lymphoma, PMBCL, High-grade B-cell lymphoma, HGBL, Lymphoma, IMPT-314
Eligibility
You can join if…
Open to people ages 18 years and up
- Age 18 years or older
- Willing and able to provide written informed consent
Histologically confirmed aggressive NHL, including the following types defined by the
World Health Organization (WHO) 2017:
- DLBCL not otherwise specified (NOS)
- DLBCL arising from follicular lymphoma
- Primary mediastinal (thymic) large B-cell lymphoma
- High-grade large B-cell lymphoma with or without MYC and BCL2 and/or BCL6 rearrangement
- Received at least 2 prior lines of therapy. Prior therapy must have included:
- Anti-CD20 monoclonal antibody
- An anthracycline containing chemotherapy regimen
- Participants with TFL must have received at least one of their prior lines of therapy after transformation to DLBCL
- Relapsed or refractory disease, defined by the following:
- Disease progression after last regimen (including salvage therapy after autologous stem cell transplantation [ASCT]), or
- Refractory disease is defined failure to achieve a PR or CR to the last regimen
- At least 1 measurable lesion (the Lugano classification). Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Absolute neutrophil count (ANC) ≥ 1000/uL
Other protocol-defined criteria apply.
You CAN'T join if...
- History of malignancy other than non-melanoma skin cancer or carcinoma in situ (e.g., cervix, bladder, breast) unless disease-free for at least 3 years. Participants who have received therapy for a prior malignancy within the prior 3 years, e.g., in the adjuvant setting, are not excluded
- Active central nervous system (CNS) involvement by malignancy on magnetic resonance imaging (MRI) or by lumbar puncture. Participants with prior evidence of brain metastasis successfully treated at least 8 weeks prior to enrollment will not be excluded for participation if they are deemed under control at the time of study enrollment
- History of cardiac lymphoma involvement
- Ongoing or impending oncologic emergency (e.g., tumor mass effect, tumor lysis syndrome)
- Received any systemic therapy within two weeks prior to enrollment/leukapheresis, except for systemic inhibitory/stimulatory immune checkpoint therapy. Received any systemic inhibitory/stimulatory immune checkpoint molecule therapy within less than 3 half-lives prior to enrollment (e.g., ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4- 1BB agonists)
- Received radiation therapy within 3 weeks prior to enrollment
- Experiencing toxicities due to prior therapy (stable and recovered to grade ≤ 1 or non- clinically significant toxicities such as alopecia are allowed)
- History of allogeneic stem cell transplantation
Receipt of autologous stem cell transplantation within 6 weeks prior to enrollment
10. History of prior CAR therapy or other genetically modified T cell therapy 11. Primary immunodeficiency 12. History of autoimmune disease (e.g., Crohn's disease, rheumatoid arthritis, systemic
lupus) resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years
Other protocol-defined criteria apply.
Locations
- University of California, Los Angeles (UCLA) Medical Center
accepting new patients
Los Angeles California 90095 United States - Huntsman Cancer Institute
not yet accepting patients
Salt Lake City Utah 84112 United States
Lead Scientist at University of California Health
- Sara M. Larson (ucla)
HS Associate Clinical Professor, Medicine. Authored (or co-authored) 16 research publications
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- ImmPACT Bio
- ID
- NCT05826535
- Phase
- Phase 1/2 research study
- Study Type
- Interventional
- Participants
- Expecting 50 study participants
- Last Updated