OncoMatch/Clinical Trials/NCT07882641
BEX101 in B-cell Non-Hodgkin's Lymphoma
Official title: A Phase I/II Clinical Study Evaluating the Safety and Efficacy of BEX101 in Patients With Relapsed/Refractory B-Cell Lymphoma
Is NCT07882641 recruiting? Yes, currently enrolling (Oct 2026). This Phase 1/2 trial studies BEX101 for non-hodgkin's lymphoma.
Treatment: BEX101 — BEX101 injection is an extracorporeal anti-CD19 Chimeric Antigen Receptor T-Cell (CAR-T cell) therapy product. This single-arm, open-label, phase I/II clinical study is designed to evaluate the safety and efficacy of BEX101 injection in patients with relapsed or refractory (r/r) B-cell non-Hodgkin's lymphoma (NHL) .
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Required: MYC rearrangement
High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements
Required: BCL2 rearrangement
High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements
Required: BCL6 rearrangement
High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements
Required: CCND1 overexpression
Mantle cell lymphoma (MCL) (pathologically confirmed, with monoclonal B cells harboring t(11;14) and/or cyclin D1 overexpression)
Required: CD19 expression (positive)
CD19-positive tumor tissue confirmed by histopathology. A prior CD19 pathology diagnosis may be accepted if confirmed by the investigator. Subjects previously treated with anti-CD19 therapy must undergo tumor biopsy to confirm current CD19-positive expression.
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: first-line standard therapy (including rituximab and an anthracycline) (rituximab, anthracycline) — first-line
achievement of complete remission (CR) after first-line standard therapy (which must include rituximab and an anthracycline), with biopsy-confirmed disease relapse within 12 months after initiation of first-line treatment
Must have received: first-line standard therapy (including rituximab and an anthracycline) (rituximab, anthracycline) — first-line
failure to achieve CR after first-line standard therapy
Must have received: autologous stem cell transplantation
Failure to achieve remission after autologous stem cell transplantation (including SD and PD), or relapse within 12 months after achieving remission (including PR and CR)
Must have received: therapy after transformation — after transformation (for transformed DLBCL)
Subjects with transformed DLBCL must have received at least one line of therapy after transformation and have r/r disease after the most recent treatment
Must have received: anthracycline- or bendamustine-containing regimen, anti-CD20 therapy, and a BTK inhibitor (anthracycline, bendamustine, anti-CD20 therapy, BTK inhibitor) — for MCL
For subjects with MCL, prior treatment must have included an anthracycline- or bendamustine-containing regimen, anti-CD20 therapy (unless CD20-negative), and a BTK inhibitor
Must have received: second-line therapy — for indolent lymphoma (FL grades 1-3a and MZL)
For subjects with indolent lymphoma (FL grades 1-3a and MZL), at least second-line prior therapy is required
Cannot have received: allogeneic stem cell transplantation
Prior allogeneic stem cell transplantation
Lab requirements
Blood counts
ANC ≥ 1.0 × 10^9/L; Platelet count ≥ 50 × 10^9/L; Hemoglobin ≥ 60 g/L (except for bone marrow suppression caused by lymphoma involvement)
Kidney function
Serum creatinine ≤ 1.5 × ULN, or Creatinine clearance (Cockcroft-Gault) ≥ 60 mL/min
Liver function
AST and ALT ≤ 3 × ULN (or ≤ 5 × ULN in the presence of liver metastases); Total bilirubin ≤ 1.5 × ULN
Cardiac function
LVEF ≥ 50% by ECHO; No pericardial effusion; No clinically significant abnormalities on 12-lead ECG
Organ function must meet the following criteria: ... see inclusion criterion 7
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07882641 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior allogeneic stem cell transplantation disqualifies patients from enrollment.
Does this trial require MYC?
Yes, MYC rearrangement is a required biomarker for enrollment.
Does this trial require BCL2?
Yes, BCL2 rearrangement is a required biomarker for enrollment.
Does this trial require BCL6?
Yes, BCL6 rearrangement is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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