Relmacabtagene autoleucel plus sintilimab for relapsed or refractory CD19‑positive 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 is a prospective, single‑arm, multicenter phase II trial enrolling adults with relapsed or refractory CD19‑positive DLBCL, FL, or MCL. Patients receive lymphodepletion with fludarabine and cyclophosphamide, then relmacabtagene autoleucel reinfusion 2–7 days later. Beginning on Day 28 after reinfusion, sintilimab 200 mg is given intravenously every 3 weeks for up to 1 year or until progression or intolerable toxicity. The primary endpoint is complete response rate at 3 months, with safety and durability of response also monitored.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. The patient must be aware of and voluntarily sign the informed consent form (ICF).
2. Aged between 18 and 70 years, both male and female.
3. Pathologically diagnosed with DLBCL, FL, or MCL, with histological confirmation of CD19 positivity (immunohistochemistry or flow cytometry, with flow cytometry used for re-evaluation if immunohistochemistry is CD19-negative).
4. The patient must be willing to receive regorafenib and sintilimab treatment and be deemed suitable for this treatment by the investigator.
5. Relapsed/refractory DLBCL, FL, or MCL.
6. At least one measurable or evaluable lesion.
7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
8. Expected survival of ≥3 months.
9. Adequate function of the heart, lungs, liver, kidneys, and other organs.

Exclusion Criteria:

1. History of another malignancy that has not been in complete remission for at least 2 years, except for: non-melanoma skin cancer, completely resected stage I tumors with low recurrence potential, treated localized prostate cancer, biopsy-confirmed cervical carcinoma in situ, or squamous intraepithelial lesions detected by Pap smear and so on.
2. Active Hepatitis B: a) Positive for Hepatitis B surface antigen (HBsAg) and/or Hepatitis B core antibody (HBcAb) , with HBV-DNA below the lower limit of the reference value can be included.
3. Hepatitis C, HIV, or syphilis infection.
4. Uncontrolled systemic fungal, bacterial, viral, or other infections.
5. Acute or chronic graft-versus-host disease (GVHD).
6. Known hypersensitivity or allergy to any study drug or excipient.
7. Clinically significant central nervous system (CNS) disease or symptoms, such as epilepsy, seizures, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychiatric illness.
8. Pregnant or breastfeeding women, and women of childbearing age who do not wish to use contraception.
9. Mentally ill individuals or those unable to provide informed consent.
10. The investigator deems the patient unsuitable for the study due to medical, psychological, familial, social, or geographical reasons or an inability to comply with the study protocol.
11. Previous CAR-T cell therapy or other gene-modified T-cell treatments.
12. Previous CD19-targeted therapy.
13. Previous allogeneic hematopoietic stem cell transplantation.

Where it's running

• Sun Yat-sen Universitiy Cancer Center
  Guangzhou, China Recruiting
• Fifth Affiliated Hospital of Guangzhou Medical University
  Guangzhou, China Not yet recruiting
• Guangzhou overseas Chinese hospital
  Guangzhou, China Not yet recruiting

Study contacts

• Study coordinator: Qingqing Cai, MD. PhD
• Email: caiqq@sysucc.org.cn
• Phone: 02087342823

Similar studies

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

• Rocbrutinib and Lacutoclax in B-cell cancers

  This study tests whether Rocbrutinib plus Lacutoclax can help adults with B-cell malignancies, including CLL/SLL, MCL, DLBCL, FL, WM, who have had prior therapy or are treatment-naïve under specific criteria.

  Recruiting Phase 1/2 Guangzhou Lupeng Pharmaceutical Company LTD. · Tianjin · NCT07609862

• Safety testing of LTZ-301 in adults with relapsed or refractory B‑cell non-Hodgkin lymphoma

  This trial will test whether LTZ-301 is safe and how it behaves in adults whose B‑cell non-Hodgkin lymphoma has come back or not responded after at least two prior treatments.

  Recruiting at 6 sites Phase 1 LTZ Therapeutics, Inc. · Duarte, California and 5 other locations · NCT07121946

• Testing EXS73565 for patients with relapsed or refractory B-cell cancers

  This study is testing a new oral medication called EXS73565 to see if it can help adults with B-cell cancers that haven't responded to other treatments.

  Recruiting at 17 sites Phase 1 Exscientia AI Limited · Tbilisi and 16 other locations · NCT06980116

• Registry platform for patients with blood cancers in Germany

  This study is setting up a national registry to collect information from patients with blood cancers in Germany to see how well different treatments work and what patients need.

  Recruiting iOMEDICO AG · Freiburg im Breisgau · NCT06043011

• Evaluating NX-5948 for advanced B-cell cancers

  This study is testing a new drug called NX-5948 to see if it can safely help adults with tough-to-treat B-cell cancers feel better.

  Recruiting at 53 sites Phase 1 Nurix Therapeutics, Inc. · Duarte, California and 61 other locations · NCT05131022

• Evaluating NX-2127 for adults with advanced B-cell cancers

  This study is testing a new treatment called NX-2127 to see if it can help adults with advanced B-cell cancers feel better and fight their disease.

  Recruiting at 7 sites Phase 1 Nurix Therapeutics, Inc. · Duarte, California and 15 other locations · NCT04830137

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.