BridgeMD
A Phase 1/2a Study of UCART20x22 in B-Cell Non-Hodgkin Lymphoma [NatHaLi-01]
EU CTIS ID: 2022-501607-27-00
What this study is testing
For the Dose-Finding Part: To assess the safety and tolerability and determine the MTD and/or RP2D of UCART20x22 in subjects with R/R mature B-NHL For the Dose-Expansion Part: To assess the safety and tolerability of UCART20x22 and confirm the RP2D in subjects with R/R LBCL
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age 18 to 80 years
- - Adequate organ function (renal, liver, cardiac, pulmonary, bone marrow)
- - Negative serologic or PCR test results for acute or chronic hepatitis B virus (HBV) infection
- 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.
- - Negative test result for hepatitis c virus (HCV) and human immunodeficiency virus (HIV).
- - Women of childbearing potential (WOCBP) must have a negative, highly sensitive serum pregnancy test performed within 7 days prior to enrollment.
You likely can't join if
- Allogeneic HSCT within 3 months of the start of LD, or donor lymphocyte infusion within 6 weeks of the start of LD
- 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
- Active acute or chronic GvHD. Subjects should be off all immunosuppressive therapies for at least 6 weeks prior to start of LD
- 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
See the full eligibility criteria
Who can join
- Age 18 to 80 years
- - Adequate organ function (renal, liver, cardiac, pulmonary, bone marrow)
- - Negative serologic or PCR test results for acute or chronic hepatitis B virus (HBV) infection
- 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.
- - Negative test result for hepatitis c virus (HCV) and human immunodeficiency virus (HIV).
- - Women of childbearing potential (WOCBP) must have a negative, highly sensitive serum pregnancy test performed within 7 days prior to enrollment.
- 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
- - Subjects 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: o DLBCL o High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements o Transformed FL or transformed marginal zone lymphoma (MZL) o Follicular lymphoma Grade 3B
- - R/R disease after at least 2 lines of prior treatment, which must have included: o 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 o An alkylating agent in combination with an anti-CD20 MoAb for FL o An anthracycline or bendamustine-containing chemotherapy regimen and a Bruton’s tyrosine kinase (BTK) inhibitor for mantle cell lymphoma (MCL) o 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.
- - At least 1 measurable lesion according to the Lugano Response Criteria for Malignant Lymphoma
- - Prior lymphoma treatment-related toxicities resolved to baseline or ≤ Grade 1 prior to start of LD regimen
What rules you out
- Allogeneic HSCT within 3 months of the start of LD, or donor lymphocyte infusion within 6 weeks of the start of LD
- 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
- Active acute or chronic GvHD. Subjects should be off all immunosuppressive therapies for at least 6 weeks prior to start of LD
- 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 weeks 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
- 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
- Known hypersensitivity to any of the test materials or related compounds including murine and bovine products
- 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 recurrent significant viral infection
- Inability for any reason to receive appropriate antimicrobial prophylaxis against Pneumocystis jiroveci, herpes, viruses, and invasive fungal infections
- More than 4 lines of therapy R/R B-NHL, prior to start of the LD regimen
- History of hypersensitivity to alemtuzumab
- History of neutralizing anti-drug antibody against alemtuzumab
- Any known uncontrolled cardiovascular disease within 3 months of enrollment
- Subjects 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)
- Positive SARS-CoV2 viral PCR test within 3 days prior to initiation of LD
The study team makes the final eligibility decision.
Where it's taking place
- United States
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. 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 EU CTIS; the study team decides eligibility.