RN1701 Injection in the Treatment of Relapsed/Refractory B-Cell Lymphomas

NCT07563543 | Not Yet Recruiting Early Phase 1

• 1 other identifier: 2026-SR-269
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

This single-arm, open-label pilot study will assess the safety and efficacy of RN1701, a bispecific CD19/CD20-targeted allogeneic CAR-T-cell product, in patients with relapsed or refractory B-cell lymphoma. Up to 19 participants will be enrolled in a conventional 3 + 3 dose-escalation scheme. The primary objective of the study is to evaluate the safety and feasibility of RN1701 for the treatment of relapsed/refractory B-cell lymphoma. The secondary objective is to evaluate the efficacy of RN1701 for the treatment of relapsed/refractory B-cell lymphoma. The exploratory objective is to evaluate the expansion, persistence, and ability of RN1701 to deplete CD19- and/or CD20-positive cells in patients with relapsed/refractory B-cell lymphoma.

Conditions

Relapsed/Refractory B-cell Lymphoma

Outcome Measures

Primary Outcomes (2)

• Toxicity and adverse event grading after RN1701 treatment

  all toxicities and AEs will be assessed according to the National Cancer Institute CTCAE v5.0

  up to 12 months after infusion

• CRS grading after RN1701 treatment

  CRS will be graded using the Lee DW et al. CRS grading scale. Grade 1: Fever, mild symptoms, manageable with supportive care Grade 2: Moderate symptoms (eg, hypotension, hypoxia), requires intervention (eg, intravenous fluids, antipyretics) Grade 3: Severe symptoms (eg, multiorgan involvement), requires corticosteroids and tocilizumab Grade 4: Life-threatening, requires intensive care unit (ICU) care and urgent interventions

  up to 12 months after infusion

Secondary Outcomes (5)

• Overall response rate (ORR =CR + PR) of patients receive RN1701 treatment

  1，3，6，and 12months after infusion

• Disease control rate (DCR=CR +PR +SD) of patients receive RN1701 treatment

  1, 3, 6 and 12 months after infusion

• Assessment includes contrast enhanced CT of head/neck, chest, abdomen,and pelvis, plus whole-body PET-CT

  1，3，6，and 12 months after infusion

• CAR copies of CAR-T in blood after RN1701 treatment

  Days 0, 1, 3, 5, 7, 9,11, 14, 21, 28 and month 2, 3, 6, 9, 12 after infusion

• Cell count of CAR-T in blood after RN1701 treatment

  Days 0, 1, 3, 5, 7, 9,11, 14, 21, 28 and month 2, 3, 6, 9, 12 after infusion

Study Arms (1)

RN1701 treatment for relapsed/refractory B-cell lymphoma

EXPERIMENTAL

Patients with relapsed/refractory B-cell lymphoma will receive a single dose of RN1701 cells.

Biological: RN1701 injection

Interventions

RN1701 injection BIOLOGICAL

RN1701 injection is a bispecific CD19/CD20-targeted allogeneic CAR-T. A single infusion of CAR-T cells will be administered intravenously

RN1701 treatment for relapsed/refractory B-cell lymphoma

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Voluntary participation; full understanding of the study and provision of written informed consent obtained before any study-related procedure not part of standard care; willingness to comply with follow-up.
• \. Age 18-75 years; either sex.
• \. ECOG performance status 0-1.
• \. Histologically confirmed large B-cell lymphoma, follicular lymphoma, mantle-cell lymphoma, or indolent lymphoma transformed to DLBCL; CD19 and/or CD20 positive.
• \. At least one measurable lesion per Lugano criteria: nodal lesion longest diameter \>1.5 cm, extranodal lesion \>1.0 cm.
• \. Prior treatment response must meet one of the following: • Large B-cell lymphoma, grade 3B follicular lymphoma, transformed indolent lymphoma: i. Primary refractory and ineligible/unable to receive autologous CAR-T: best response PD after ≥2 cycles of first-line therapy, or SD after ≥4 cycles. ii. Relapse ≤12 months after achieving CR with first-line chemo-immunotherapy. iii. Relapse/progression ≤12 months after autologous HSCT. iv. Refractory to, relapsed after, or progressed on ≥2 prior lines (including autologous CAR-T): best response PD or SD after ≥2 cycles of the most recent regimen. v. Transformed indolent lymphoma: prior chemotherapy for iNHL and ≥1 systemic regimen after transformation, fulfilling the above refractory/relapse criteria. • Grade 1, 2, or 3A follicular lymphoma: i. Primary refractory and ineligible/unable to receive autologous CAR-T: best response PD after ≥2 cycles of first-line therapy. ii. Refractory to, relapsed after, or progressed on ≥2 prior lines (including autologous CAR-T): best response PD or SD after ≥2 cycles of the most recent regimen. • Mantle-cell lymphoma: i. Primary refractory and ineligible/unable to receive autologous CAR-T: best response PD after ≥2 cycles of first-line therapy, or SD after ≥4 cycles. ii. Refractory to, relapsed after, or progressed on ≥2 prior lines (including autologous CAR-T): best response PD or SD after ≥2 cycles of the most recent regimen.
• \. Estimated life expectancy ≥3 months.
• \. Screening laboratory values (may be repeated once): • Hemoglobin ≥8.0 g/dL (no transfusion within 7 days). • Platelets ≥50×10⁹/L (no transfusion within 7 days). • ANC ≥1.0×10⁹/L (growth-factor support allowed if none within 7 days of test). • AST/ALT ≤3×ULN (≤5×ULN if liver involvement). • Serum creatinine ≤1.5×ULN or CrCl ≥60 mL/min (Cockcroft-Gault). • Total bilirubin ≤2×ULN (≤3×ULN if liver involvement); except congenital bilirubin disorders (e.g., Gilbert's syndrome: direct bilirubin ≤1.5×ULN). • INR, PT, APTT \<1.5×ULN.
• \. Toxicities from prior anti-cancer therapy (except alopecia, nausea, and the above lab values) must have stabilized at baseline or resolved to ≤Grade 1.
• \. WOCBP must have a negative high-sensitivity serum β-hCG pregnancy test at screening and again before the first dose of cyclophosphamide/fludarabine.
• \. Subjects of reproductive potential must use effective contraception for ≥12 months after completing study therapy.

You may not qualify if:

• Subjects with any of the following conditions are ineligible for this trial:
• \. Any malignancy other than B-cell non-Hodgkin lymphoma ever diagnosed or treated, except: • Malignancy that received curative therapy and has shown no evidence of active disease for ≥2 years before enrolment; or • Adequately treated non-melanoma skin cancer with no current evidence of disease.
• \. Prior anti-cancer therapy within the stated windows (before lymphodepletion): • CNS prophylaxis (e.g., intrathecal methotrexate and/or cytarabine) within 7 days; • Cytotoxic chemotherapy or radiotherapy within 14 days; • Small-molecule targeted or epigenetic therapy within 14 days or 5 half-lives, whichever is longer; • Monoclonal antibody, bispecific antibody, or antibody-drug conjugate within 21 days or 5 half-lives, whichever is shorter; • Investigational drug or invasive investigational device within 28 days (if the therapy is also investigational, the 28-day wash-out applies); • Autologous haematopoietic stem-cell transplant or CD19-directed autologous CAR-T therapy within 100 days.
• \. Any autologous cellular or gene therapy other than CD19-directed autologous CAR-T.
• \. Any allogeneic cellular (including CAR-T) or gene therapy.
• \. Prior allogeneic haematopoietic stem-cell transplantation.
• \. Positive donor-specific antibody (DSA).
• \. At least one of the following high-risk features: • Sum of the product of perpendicular diameters (SPD) of all measurable lesions ≥100 cm²; • Bulky disease: single mass ≥7.5 cm; mediastinal mass with maximum diameter \>1/3 of thoracic diameter; • Obstructive/compressive emergency (e.g., bowel obstruction, vascular compression) requiring urgent intervention at screening.
• \. Active CNS involvement (symptomatic or positive CSF/imaging); subjects with prior CNS disease now in remission (asymptomatic with negative CSF and imaging) are eligible.
• \. Significant bleeding diathesis: gastrointestinal bleeding, haemorrhagic cystitis, coagulopathy, hypersplenism (splenomegaly on exam/US, cytopenias, hyperplastic marrow) or ongoing anticoagulation.
• \. Chronic concomitant systemic corticosteroids or other immunosuppressants, except: topical, ocular, intra-articular, nasal or inhaled corticosteroids; short-course steroids for prophylaxis (e.g., contrast allergy).
• \. Severe underlying medical conditions: • Active serious viral, bacterial or uncontrolled systemic fungal infection; • Active systemic autoimmune disease requiring therapy.
• \. Significant cardiac disease: • NYHA class III or IV congestive heart failure; • Myocardial infarction or CABG within 6 months before enrolment; • Clinically relevant ventricular arrhythmia or unexplained syncope not vasovagal or dehydration-related; • Severe non-ischaemic cardiomyopathy; • Left ventricular ejection fraction (LVEF) \<45% by echo or MUGA within 4 weeks before lymphodepletion.
• \. Resting oxygen saturation \<92%.
• \. Clinically relevant prior or current CNS disorder: epilepsy, seizure-like episodes, paralysis, aphasia, stroke, severe head trauma, dementia, Parkinson's disease, cerebellar disorder, organic brain syndrome or major psychiatric illness.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

MeSH Terms

Conditions

Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Lei Fan

CONTACT

025-68306124; fanlei3014@126.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: May 4, 2026
• Study Start (Estimated): May 8, 2026
• Primary Completion (Estimated): May 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share