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

NCT07316920 | Not Yet Recruiting Phase 1

• 1 other identifier: RN1701JB
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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

Keywords

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

  Cytokine Release Syndrome (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 (4)

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

  1, 3, 6, and 12 months 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 and 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)

Relapsed/refractory B-cell lymphoma

EXPERIMENTAL

Relapsed/refractory B-cell lymphoma patients to be treated with 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

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):

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).

Sponsors & Collaborators

• YANRU WANG: lead
• Allorunning Therapeutics: collaborator

Study Sites (1)

Affiliated Hospital of Jiangsu University

Zhenjiang, Jiangsu, 212001, China

Location

MeSH Terms

Conditions

Lymphoma, B-Cell; Recurrence

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; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Xiaoming Fei, PhD

CONTACT

086-1381512462752; feixiaomingujs@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: January 5, 2026
• Study Start: December 22, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)