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New treatment option for B-cell Non-Hodgkin Lymphoma (B-NHL)
Official title Study Evaluating UCART20x22 in B-Cell Non-Hodgkin Lymphoma
ClinicalTrials.gov ID: NCT05607420
What this study is testing
What is UCART20x22?
UCART20x22 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for b-cell non-hodgkin lymphoma (b-nhl).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- First-in-human, open-label, dose-finding and dose-expansion study of UCART20x22 administered intravenously in subjects with relapsed or refractory B-Cell Non-Hodgkin Lymphoma (B-NHL). The purpose of this study is to evaluate the safety and clinical activity of UCART20x22 and determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Relapsed or refractory (R/R) mature B-NHL per 2016 WHO criteria and positive for CD20 and/or CD22
- people with NHL subtypes defined by WHO:
- Dose-Finding Part: R/R mature B-NHL (except chronic lymphocytic leukemia/small lymphocytic leukemia [CLL/SLL], Richter's transformation from prior...
- Dose-Expansion Part: R/R LBCL, defined as: i. DLBCL; ii. High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements; iii. Transformed FL...
You likely can't join if
- Prior use of an investigational product (except for cell or gene therapies and MoAbs) within 5 half-lives or within 14 days, whichever is shorter...
- Previous approved therapy including chemotherapy, biologic (except MoAbs), or targeted therapy for R/R B-NHL with 5 half-lives or within 14 days...
- \> 4 lines of therapy R/R B-NHL prior to start of the LD regimen.
- Prior MoAb therapy (approved or investigational) within 30 days prior to start of LD
- Prior systemic immunostimulatory agent within 3 half-lives prior to start of the LD regimen
- Prior cell or gene therapy (approved or investigational) within 6 months of the start of LD
See the full eligibility criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Relapsed or refractory (R/R) mature B-NHL per 2016 WHO criteria and positive for CD20 and/or CD22
- people with NHL subtypes defined by WHO:
- Dose-Finding Part: R/R mature B-NHL (except chronic lymphocytic leukemia/small lymphocytic leukemia [CLL/SLL], Richter's transformation from prior CLL/SLL, Burkitt's lymphoma, and Waldenstrom's macroglobulinemia)
- Dose-Expansion Part: R/R LBCL, defined as: i. DLBCL; ii. High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements; iii. Transformed FL or transformed marginal zone lymphoma (MZL); iv. Follicular lymphoma...
- R/R disease after at least 2 lines of prior treatment, which must have included:
- An Anti-CD20 MoAb and an anthracycline for DLBCL, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, primary mediastinal large B-cell lymphoma (PMBCL), or transformed FL or MZL
- An alkylating agent in combination with an anti-CD20 MoAb for FL
- An anthracycline or bendamustine-containing chemotherapy regimen and a Bruton's tyrosine kinase (BTK) inhibitor for mantle cell lymphoma (MCL)
- Autologous anti-CD19 CAR T-cell therapy, if approved and available for the indicated lymphoma subtype, unless the subject is unable or is ineligible to receive approved autologous anti-CD19 CAR T-cell therapy (e.g...
- Autologous hematopoietic stem cells must be available prior to the start of the LD regimen if the subject is considered high-risk for prolonged hematologic toxicity.
- Prior use of an investigational product (except for cell or gene therapies and MoAbs) within 5 half-lives or within 14 days, whichever is shorter, prior to start of LD regimen
- Previous approved therapy including chemotherapy, biologic (except MoAbs), or targeted therapy for R/R B-NHL with 5 half-lives or within 14 days, whichever is shorter, prior to start of the LD regimen
- \> 4 lines of therapy R/R B-NHL prior to start of the LD regimen.
- Prior MoAb therapy (approved or investigational) within 30 days prior to start of LD
- Prior systemic immunostimulatory agent within 3 half-lives prior to start of the LD regimen
- Prior cell or gene therapy (approved or investigational) within 6 months of the start of LD
- Prior cell or gene therapy (approved or investigational) targeting both CD20 and CD22
- Autologous HSCT infusion within 6 weeks of the start of LD
- Allogeneic HSCT within 3 months of the start of LD, or donor lymphocyte infusion within 6 weeks of the start of LD
- Active acute or chronic graft versus host disease (GvHD). people should be off all immunosuppressive therapies for at least 6 weeks prior to start of LD
- Radiotherapy within 8 weeks (except for palliative radiotherapy for specific on-target lesions) (prior to start of LD regimen)
- Evidence of active central nervous system (CNS) lymphoma or previous CNS involvement of R/R B-NHL
- Presence of an active and clinically relevant CNS disorder
- Daily treatment with \>20 mg prednisone or equivalent
- Known active infection, or reactivation of a latent infection, whether bacterial or viral, fungal, mycobacterial, or other pathogens
- History of hypersensitivity to alemtuzumab
- History of neutralizing anti-drug antibody against alemtuzumab
- Any known uncontrolled cardiovascular disease within 3 months of enrollment
- people requiring immunosuppressive treatment
- Major surgery within 28 days prior to start of LD
- Evidence of another uncontrolled malignancy within 2 years prior to Screening (except in situ nonmelanoma skin cell cancers and/or carcinoma in-situ of the cervix)
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- New Brunswick, New Jersey, United States
- Austin, Texas, United States
- Pierre-Bénite, Auvergne Rhone Alpe, France
- Montpellier, Occitanie, France
- Nantes, France
- Paris, Île-de-France Region, France
- Pamplona, Navarre, Spain
- Seville, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States; Boston, Massachusetts, United States; New Brunswick, New Jersey, United States; Austin, Texas, United States; Pierre-Bénite, Auvergne Rhone Alpe, France; Montpellier, Occitanie, France and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.