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New treatment option for B Cell Lymphoma
Official title A Clinical Study of Allogeneic CD19/BCMA CAR-T Cells for the Treatment of R/R B-cell Malignant Tumors
ClinicalTrials.gov ID: NCT06976437
What this study is testing
What is RN1101 injection?
RN1101 injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for b cell lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A single arm, open-label pilot study is designed to determine the safety and efficacy of CD19 and B-cell maturation antigen (BCMA) targeted allogenic CAR-T cells (RN1101) in patients with relapsed/refractory B-cell or plasma cell-derived malignant tumors. 21 patients are planned to be enrolled in the dose-escalation trial.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Willingness to participate in the trial and provision of signed informed consent.
- Patients diagnosed with B-lymphocyte or plasma cell-derived malignancies as per the 2017 revised WHO criteria, including acute B-lymphoblastic...
- Refractory or recurrent B-lymphocyte or plasma cell-derived malignancies, defined as failure to achieve complete remission after standard treatment...
- Patients with B-cell acute lymphoblastic leukemia (ALL) who have achieved hematologic remission but have persistent minimal residual disease (MRD).
- According to the revised International Working Group (IWG) criteria, relapsed/refractory lymphoma patients must have at least one measurable lesion...
You likely can't join if
- Known allergies, hypersensitivity, intolerance, or contraindications to CD19/BCMA allogenic CAR-T or any components of the trial drugs (including...
- Recurrence after allogeneic hematopoietic stem cell transplantation with active graft - versus - host disease (GVHD) requiring steroid or...
- Severe active infection.
- Acquired or congenital immunodeficiency.
- New York Heart Association (NYHA) Class Ⅲ or Ⅳ heart failure.
- History of epilepsy or other central nervous system diseases.
See the full eligibility criteria
- Willingness to participate in the trial and provision of signed informed consent.
- Patients diagnosed with B-lymphocyte or plasma cell-derived malignancies as per the 2017 revised WHO criteria, including acute B-lymphoblastic leukemia (B-ALL), and mature B-cell lymphomas such as diffuse large B-cell...
- Refractory or recurrent B-lymphocyte or plasma cell-derived malignancies, defined as failure to achieve complete remission after standard treatment, or relapse during follow-up after achieving remission with first-line...
- Patients with B-cell acute lymphoblastic leukemia (ALL) who have achieved hematologic remission but have persistent minimal residual disease (MRD).
- According to the revised International Working Group (IWG) criteria, relapsed/refractory lymphoma patients must have at least one measurable lesion with a longest diameter ≥1.5 cm.
- 18 Years and older, regardless of gender.
- An expected survival of ≥12 weeks.
- Serum total bilirubin level \< twice the upper limit of normal, serum creatinine level \< upper limit of normal, serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< three times the upper limit...
- Absolute neutrophil count ≥0.5×10⁹/L, platelets ≥20×10⁹/L; for B-lymphocyte malignancies with definitive bone marrow involvement, no requirements for neutrophil and platelet counts.
- ECOG performance status of 0 - 2.
- Left ventricular ejection fraction (LVEF) ≥50% and no pericardial effusion.
- At least 2 weeks have passed since the last treatment (radiotherapy, chemotherapy, monoclonal antibody therapy, or other treatments).
- Known allergies, hypersensitivity, intolerance, or contraindications to CD19/BCMA allogenic CAR-T or any components of the trial drugs (including fludarabine, cyclophosphamide, and rituximab), or a history of severe...
- Recurrence after allogeneic hematopoietic stem cell transplantation with active graft - versus - host disease (GVHD) requiring steroid or immunosuppressive therapy.
- Severe active infection.
- Acquired or congenital immunodeficiency.
- New York Heart Association (NYHA) Class Ⅲ or Ⅳ heart failure.
- History of epilepsy or other central nervous system diseases.
- Lymphoma with extranodal involvement of the brain, lungs, or gastrointestinal tract.
- Other primary cancers, except:
- Non-melanoma skin cancer (e.g., basal cell carcinoma) cured by resection.
- Carcinoma in situ (e.g., cervical, bladder, or breast cancer) cured.
- Systemic high-dose steroids within 2 weeks before treatment.
- Pregnant, breastfeeding, or plans to become pregnant within 6 months.
- Participation in another clinical trial within the past month.
- Any situation the investigator deems may raise risks or interfere with trial results.
The study team makes the final eligibility decision.
Where it's taking place
- Zhenjiang, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zhenjiang, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.