New combo therapy aims to beat back tough lymphomas
NCT ID NCT07077512
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial is testing a combination of two drugs—a CAR-T cell therapy (relmacabtagene autoleucel) and a PD-1 inhibitor (sintilimab)—in 30 adults with relapsed or refractory B-cell lymphoma. The goal is to see if the combo can shrink tumors and improve survival. Participants receive the CAR-T infusion first, then start the PD-1 inhibitor about a month later, continuing for up to a year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CAR-T cell therapy (relmacabtagene autoleucel) plus a PD-1 inhibitor (sintilimab)
- What this could lead to
- If successful, this combination could offer a new treatment option for patients with hard-to-treat B-cell lymphomas that have not responded to standard therapies.
- What could go wrong
- This is a small, early-phase trial with only 30 participants, so results may not apply to everyone. Side effects from CAR-T therapy and PD-1 inhibitors can be serious, including immune reactions and organ inflammation.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Sep 2025
- Expected to finish
-
Jul 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 70 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Follicular lymphoma (FL) are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
3 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Fifth Affiliated Hospital of Guangzhou Medical University
NOT_YET_RECRUITINGGuangzhou, 510060, China
-
Guangzhou overseas Chinese hospital
NOT_YET_RECRUITINGGuangzhou, 510632, China
-
Sun Yat-sen Universitiy Cancer Center
RECRUITINGGuangzhou, 51000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Real-World data may reveal how acalabrutinib performs in chinese blood cancer patients
- Can a drug combo shrink Hard-to-Treat lymphoma tumors?
- Can 'Memory-Enhanced' immune cells outsmart lymphoma?
- Can a chemo-free cocktail tame mantle cell lymphoma?
- Can a Three-Drug cocktail replace chemo for follicular lymphoma?
- Engineered immune cells take on tough lymphomas