Relmacabtagene autoleucel plus sintilimab for relapsed or refractory CD19‑positive B‑cell lymphoma
A Single-arm, Phase II Clinical Study of Relmacabtagene Autoleucel Combined With Sintilimab for Relapsed/Refractory B-cell Lymphoma.
This trial will test whether giving relmacabtagene autoleucel followed by the PD‑1 drug sintilimab helps adults with relapsed or refractory CD19‑positive large B‑cell, follicular, or mantle cell lymphoma.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | sintilimab, CAR-T, cyclophosphamide, fludarabine |
| Locations | 3 sites (Guangzhou and 2 other locations) |
| Trial ID | NCT07077512 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18–70 with relapsed or refractory CD19‑positive DLBCL, FL, or MCL who have at least one measurable lesion, ECOG 0–2, expected survival ≥3 months, and adequate organ function are the intended participants.
Not a fit: Patients with CD19‑negative disease, uncontrolled comorbidities or organ failure, other active cancers not in remission, very limited life expectancy, or who cannot access the Guangzhou sites are unlikely to benefit.
Why it matters
Potential benefit: If successful, the combination could raise complete remission rates and extend duration of response compared with historical CAR‑T outcomes.
How similar studies have performed: Early‑phase trials combining CD19 CAR‑T therapy with PD‑1 blockade have shown promising responses in some patients but remain experimental and not yet validated in large randomized studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Guangzhou and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.