Evaluating Prizloncabtagene Autoleucel for patients with relapsed/refractory large B-cell lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, single-arm, open-label study aims to assess the safety and efficacy of Prizloncabtagene Autoleucel (Prizlon-cel) in patients with relapsed or refractory large B-cell lymphoma. The study consists of two phases: Phase 1b focuses on determining the recommended Phase 2 dose (RP2D), while Phase 2 evaluates the treatment's efficacy. Participants will undergo a series of procedures including screening, apheresis for CAR-T manufacturing, lymphodepletion, and CAR-T infusion, followed by a minimum of two years of follow-up. Long-term follow-up may extend up to 15 years in a separate study.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* ≥ 18 years of age
* Histologically confirmed CD19 or CD20 positive B-cell non-Hodgkin lymphoma, including the following neoplasms as defined by the 2016 WHO classification of lymphoid neoplasms:

  1. Diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS)
  2. Primary mediastinal large B-cell lymphoma (PMBCL)
  3. Transformed follicular lymphoma (tFL)
  4. High-grade B-cell lymphoma, with MYC and BCL2 and/or BCL6 rearrangements (HGBL-DH/TH)
  5. High-grade B-cell lymphoma, NOS (HGBL, NOS)
  6. Follicular lymphoma grade 3B (FL3B)
* Relapsed or refractory disease after ≥ 2 lines of standard therapy or relapsed after autologous stem cell transplantation (ASCT)
* At least one measurable lesion per the Lugano 2014 Classification
* Adequate organ and marrow function

Exclusion Criteria:

* Prior allogeneic hematopoietic stem cell transplantation (HSCT) at anytime, or ASCT within 12 weeks prior to apheresis
* Suspected or confirmed central nervous system involvement
* Stroke or convulsion history within 6 months of signing informed consent form (ICF)
* Autoimmune disease, immunodeficiency or diseases requiring immunosuppressants treatment
* Uncontrolled active infection
* Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with detectable hepatitis B virus (HBV) DNA in peripheral blood; positive hepatitis C virus (HCV) antibody with positive HCV RNA in peripheral blood; positive human immunodeficiency virus (HIV) antibody; positive syphilis test
* Severe heart, liver, renal or metabolism disease
* Inadequate wash-out time for previous anti-tumor treatments prior to apheresis
* Prior CAR-T therapy

Where it's running

• Beijing GoBroad Hospital
  Beijing, China Recruiting
• Peking University Third Hospital
  Beijing, China Recruiting
• Chongqing University Cancer Hospital
  Chongqing, China Recruiting
• Guangdong Provincial People's Hospital
  Guangzhou, China Recruiting
• Zhujiang Hospital of Southern Medical University
  Guangzhou, China Recruiting
• The First Affiliated Hospital Zhejiang University School of Medicine
  Hangzhou, China Recruiting

Study contacts

• Principal investigator: Weili Zhao, M.D., PhD — Ruijin Hospital
• Study coordinator: Weili Zhao, M.D., PhD
• Email: zwl_trial@163.com
• Phone: 86-021-64370045

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• In Vivo CD19/CD20 CAR T-Cell Therapy for Relapsed or Refractory B-Cell Lymphoma

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• CD5 CAR T-cell therapy for relapsed or refractory T-cell lymphoma

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• Glofitamab plus obinutuzumab for mantle cell lymphoma after CAR‑T

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• CD7 CAR T-Cell Therapy for T-Cell Lymphomas

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• Using golcadomide and rituximab to prepare patients for CAR T-cell therapy in aggressive B-cell lymphoma

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  Recruiting at 7 sites Phase 2 Mayo Clinic · Scottsdale, Arizona and 6 other locations · NCT06834373

• Loncastuximab tesirine plus rituximab as bridging therapy before CAR-T for relapsed or refractory large B‑cell lymphoma

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.