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Trial Title: Study of IMPT-314 in R/R Aggressive B-cell NHL

NCT ID: NCT05826535

Condition: Relapsed Non-Hodgkin Lymphoma
Refractory Non-Hodgkin Lymphoma

Conditions: Official terms:
Lymphoma
Lymphoma, Non-Hodgkin

Conditions: Keywords:
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
follicular lymphoma Grade 3B
large cell follicular lymphoma

Study type: Interventional

Study phase: Phase 1/Phase 2

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Sequential Assignment

Intervention model description: Dose finding Phase I followed by a Phase II part. Two Phase I dose levels and one Phase II dose level. Three cohorts in each phase.

Primary purpose: Treatment

Masking: Single (Outcomes Assessor)

Masking description: Analysis of response will be performed by Blinded Independent Central Review (BICR) Discordance between the Investigator assessment and BICR assessment will be evaluated for each efficacy endpoints based on tumor assessments if BICR assessments are performed.

Intervention:

Intervention type: Drug
Intervention name: IMPT-314
Description: CAR T-cell therapy
Arm group label: Phase I Dose Level I CAR T experienced cohort
Arm group label: Phase I Dose Level I CAR T naïve cohort
Arm group label: Phase I Dose Level I Refractory disease or relapse within one year of first line therapy
Arm group label: Phase I Dose Level II CAR T experienced cohort
Arm group label: Phase I Dose Level II CAR T naïve cohort
Arm group label: Phase I Dose Level II Refractory disease or relapse within one year of first line therapy
Arm group label: Phase II CAR T experienced cohort
Arm group label: Phase II CAR T naïve cohort
Arm group label: Phase II Refractory disease or relapse within one year of first line therapy

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. Three cohorts of participants will be enrolled: 1) CAR T naïve after at least two or more prior lines of treatment, 2) CAR T experienced and 3) refractory disease or relapse within one year of first line therapy. Up to approximately 90 patients (30 per cohort) will be enrolled in dose finding Phase 1 part of the study, which will determine the recommended phase 2 dose. Phase 2 will enroll up to approximately 60 additional participants (20 per cohort) 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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Age 18 years or older 2. Willing and able to provide written informed consent 3. Histologically confirmed aggressive NHL, including the following types defined by the World Health Organization (WHO 2017): - DLBCL - DLBCL arising from follicular lymphoma (Transformed FL) - Primary mediastinal (thymic) large B-cell lymphoma - High-grade large B-cell lymphoma with or without MYC and BCL2 and/or BCL6 rearrangement - Grade 3b follicular lymphoma/Large cell follicular lymphoma 4. Received at least 1 prior line 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 5. Relapsed or refractory disease, defined by the following: - Disease progression after last regimen (including salvage therapy after autologous stem cell transplantation [ASCT]). In participants who have only received front-line therapy, progression should be ≤12 months of first-line therapy. - In patients who received two or more lines of therapy, refractory disease is defined as failure to achieve a CR to last line of therapy (including CAR T and/or salvage therapy). - In patients who received one line of therapy, refractory disease is defined as failure to achieve at least a PR after at least 4 cycles of therapy 6. 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 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 8. Absolute neutrophil count (ANC) ≥ 1000/uL Other protocol-defined criteria apply. Exclusion Criteria: 1. 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 2. Active central nervous system (CNS) involvement by malignancy on magnetic resonance imaging (MRI) or by lumbar puncture. Participants with prior evidence of brain metastasis treated at least 8 weeks prior to enrollment will not be excluded for participation if CNS disease is deemed stable at the time of study enrolment 3. History of cardiac lymphoma involvement 4. Ongoing or impending oncologic emergency (e.g., tumor mass effect, tumor lysis syndrome) 5. Received the following therapies in the specified time frame prior to enrollment/leukapheresis 1. Any systemic therapy within 2 weeks 2. Any systemic inhibitory/stimulatory immune checkpoint molecule therapy within 3 half-lives prior to enrollment (e.g., ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4- 1BB agonists) 3. Fludarabine within 12 weeks 4. Alemtuzumab, bendamustine or antithymocyte globuline (ATG) within 6 months 5. Any T cell engager/bispecific antibody therapy such as CD20/CD3 or CD19/CD3 bispecific antibodies within 4 weeks 6. Any experimental therapy within 4 weeks or 5 half-lives (whichever is shorter) 6. Received radiation therapy within 3 weeks prior to enrollment 7. Experiencing non-hematologic toxicities due to prior therapy (stable and recovered to grade ≤ 1 or non- clinically significant toxicities such as alopecia are allowed) 8. History of allogeneic stem cell or solid organ transplantation 9. Receipt of autologous stem cell transplantation within 6 weeks prior to enrollment 10. History of prior genetically modified cell therapy other than a product targeting CD19 with an FMC63-based CAR (e.g., axicabtagene ciloleucel (axi-cel, YESCARTA®), tisagenlecleucel (tisa-cel, KYMRIAH®), or lisocabtagene maraleucel (liso-cel, BREYANZI®). For all other CAR T cell therapy treatments, discussion with the Sponsor's Medical Monitor is required 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. Participants who have other autoimmune condition(s) considered to be associated with underlying malignancy may be enrolled in the study after discussion with and approval of the Medical Monitor. Other protocol-defined criteria apply.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University of California-Irvine Medical Center

Address:
City: Irvine
Zip: 92697
Country: United States

Status: Recruiting

Contact:
Last name: Blake Johnson
Email: blakej@hs.uci.edu

Investigator:
Last name: Stefan Ciurea
Email: Principal Investigator

Facility:
Name: Cedars-Sinai Medical Center

Address:
City: Los Angeles
Zip: 90048
Country: United States

Status: Recruiting

Contact:
Last name: Akil Merchant

Phone: 310-423-5706
Email: Akil.Merchant@cshs.org

Investigator:
Last name: Akil Merchant
Email: Principal Investigator

Facility:
Name: University of California, Los Angeles (UCLA) Medical Center

Address:
City: Los Angeles
Zip: 90095
Country: United States

Status: Recruiting

Contact:
Last name: Christopher M. Hannigan

Phone: 310-825-4493
Email: CHannigan@mednet.ucla.edu

Investigator:
Last name: Sara M. Larson
Email: Principal Investigator

Facility:
Name: Scripps Clinic

Address:
City: San Diego
Zip: 92037
Country: United States

Status: Recruiting

Contact:
Last name: James Mason
Email: Mason.James@scrippshealth.org

Investigator:
Last name: James Mason
Email: Principal Investigator

Facility:
Name: Augusta University Medical Center

Address:
City: Augusta
Zip: 30912
Country: United States

Status: Recruiting

Contact:
Last name: Amanda Spires

Phone: 706-721-8981
Email: amspires@augusta.edu

Investigator:
Last name: Locke Bryan
Email: Principal Investigator

Facility:
Name: Indiana Blood and Marrow Transplantation

Address:
City: Indianapolis
Zip: 46237
Country: United States

Status: Recruiting

Contact:
Last name: Melanie Coleman

Phone: 317-528-7298
Email: Melanie.Coleman@franciscanalliance.org

Investigator:
Last name: Felix Mensah
Email: Principal Investigator

Facility:
Name: University of Iowa

Address:
City: Iowa City
Zip: 52242
Country: United States

Status: Recruiting

Contact:
Last name: Umar Farooq

Phone: 319-356-1616
Email: umar-farooq@uiowa.edu

Investigator:
Last name: Umar Farooq
Email: Principal Investigator

Facility:
Name: University of Louisville Brown Cancer Center

Address:
City: Louisville
Zip: 40202
Country: United States

Status: Recruiting

Contact:
Last name: Mohamed Hegazi

Phone: 502-562-3367
Email: mohamed.hegazi@louisville.edu

Investigator:
Last name: Mohamed Hegazi
Email: Principal Investigator

Facility:
Name: University of New Mexico Comprehensive Cancer Center

Address:
City: Albuquerque
Zip: 87131
Country: United States

Status: Recruiting

Contact:
Last name: Valerie Parks

Phone: 404-925-0390
Email: Vparks@salud.unm.edu

Investigator:
Last name: Matthew L. Fero
Email: Principal Investigator

Facility:
Name: Montefiore Medical Center

Address:
City: Bronx
Zip: 10461
Country: United States

Status: Recruiting

Contact:
Last name: Dennis Cooper
Email: decooper@montefiore.org

Investigator:
Last name: Dennis Cooper
Email: Principal Investigator

Facility:
Name: University of Cincinnati (UC) Physicians Company, LLC

Address:
City: Cincinnati
Zip: 45267
Country: United States

Status: Recruiting

Contact:
Last name: Tahir Latif

Phone: 513-558-2115
Email: tahir.latif@uc.edu

Investigator:
Last name: Tahir Latif
Email: Principal Investigator

Facility:
Name: Baylor University Medical Center

Address:
City: Dallas
Zip: 75246
Country: United States

Status: Recruiting

Contact:
Last name: Nebu Koshy
Email: Nebu.Koshy@BSWHealth.org

Investigator:
Last name: Nebu Koshy
Email: Principal Investigator

Facility:
Name: Huntsman Cancer Institute

Address:
City: Salt Lake City
Zip: 84112
Country: United States

Status: Recruiting

Contact:
Last name: Lindsay Gilstrap

Phone: 801-213-5652
Email: Lindsey.Gilstrap@hci.utah.edu

Investigator:
Last name: Boyu Hu
Email: Principal Investigator

Facility:
Name: Intermountain Healthcare

Address:
City: Salt Lake City
Zip: 84143
Country: United States

Status: Recruiting

Contact:
Last name: Bradley Hunter

Phone: 801-408-1819
Email: Brad.Hunter@imail.org

Investigator:
Last name: Bradley Hunter
Email: Principal Investigator

Facility:
Name: Virginia Commonwealth University-Massey Cancer Center

Address:
City: Richmond
Zip: 23298
Country: United States

Status: Recruiting

Contact:
Last name: Kristin Lantis

Phone: 804-628-6430
Email: masseybmt@vcu.edu

Investigator:
Last name: William Clark
Email: Principal Investigator

Start date: May 9, 2023

Completion date: December 1, 2029

Lead sponsor:
Agency: ImmPACT Bio
Agency class: Industry

Source: ImmPACT Bio

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05826535

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