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

NCT ID: NCT07316920

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-22
• Study Completion Date: 2027-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Relapsed/refractory B-cell lymphoma

Relapsed/refractory B-cell lymphoma patients to be treated with RN1701 cells.

Group Type: EXPERIMENTAL

RN1701 injection

Intervention Type: BIOLOGICAL

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

Interventions

RN1701 injection

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. 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.

2. Age 18-75 years; either sex.

3. ECOG performance status 0-1.

4. Histologically confirmed large B-cell lymphoma, follicular lymphoma, mantle-cell lymphoma, or indolent lymphoma transformed to DLBCL; CD19 and/or CD20 positive.

5. At least one measurable lesion per Lugano criteria: nodal lesion longest diameter >1.5 cm, extranodal lesion >1.0 cm.

6. 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.

7. Estimated life expectancy ≥3 months.

8. 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.

9. Toxicities from prior anti-cancer therapy (except alopecia, nausea, and the above lab values) must have stabilized at baseline or resolved to ≤Grade 1.

10. WOCBP must have a negative high-sensitivity serum β-hCG pregnancy test at screening and again before the first dose of cyclophosphamide/fludarabine.

11. Subjects of reproductive potential must use effective contraception for ≥12 months after completing study therapy.

Exclusion Criteria

• Subjects with any of the following conditions are ineligible for this trial:

1. 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.

2. 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.

3. Any autologous cellular or gene therapy other than CD19-directed autologous CAR-T.

4. Any allogeneic cellular (including CAR-T) or gene therapy.

5. Prior allogeneic haematopoietic stem-cell transplantation.

6. Positive donor-specific antibody (DSA).

7. 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.

8. Active CNS involvement (symptomatic or positive CSF/imaging); subjects with prior CNS disease now in remission (asymptomatic with negative CSF and imaging) are eligible.

9. Significant bleeding diathesis: gastrointestinal bleeding, haemorrhagic cystitis, coagulopathy, hypersplenism (splenomegaly on exam/US, cytopenias, hyperplastic marrow) or ongoing anticoagulation.

10. 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).

11. Severe underlying medical conditions:

• Active serious viral, bacterial or uncontrolled systemic fungal infection;
• Active systemic autoimmune disease requiring therapy.

12. 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.

13. Resting oxygen saturation <92%.

14. 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.

15. Live-attenuated vaccine within 4 weeks before screening.

16. Major surgery within 2 weeks before screening or planned within 2 weeks after study treatment (local anaesthesia allowed).

17. Positive screen for HBsAg, HBeAg, HBV DNA, HCV antibody, HCV RNA, or HIV antibody.

18. Life-threatening allergy, hypersensitivity or intolerance to study-drug excipients including, but not limited to, DMSO.

19. Lactating women.

20. Any condition that, in the investigator's opinion, renders the subject unsuitable for the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allorunning Therapeutics

INDUSTRY

Sponsor Role: collaborator

YANRU WANG

OTHER

Sponsor Role: lead

Responsible Party

YANRU WANG

Clinical Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Affiliated Hospital of Jiangsu University

Zhenjiang, Jiangsu, China

Countries

China

Central Contacts

Xiaoming Fei, PhD

Role: CONTACT

feixiaomingujs@aliyun.com

086-1381512462752

Facility Contacts

Xiaoming Fei, PhD

Role: primary

feixiaomingujs@aliyun.com

086-1381512462752

Other Identifiers

RN1701JB

Identifier Type: -

Identifier Source: org_study_id