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Relapsed/Refractory B-cell LymphomaEarly Phase 1NCT07563543

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

A Early Phase 1 study testing RN1701 injection in people with Relapsed/Refractory B-cell Lymphoma, run by The First Affiliated Hospital with Nanjing Medical University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Relapsed/Refractory B-cell Lymphoma
What is being tested?
RN1701 injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
No sites listed yet
Study dates
8 May 2026to 30 Jun 2028
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Lei Fan contact

025-68306124

fanlei3014@126.com

About this study

Official title: An Exploratory Clinical Study of the Safety and Efficacy of RN1701 Injection in the Treatment of Relapsed/Refractory B-Cell Lymphomas

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.

Being tested
RN1701 injection
Medical subject headings
Lymphoma, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RN1701 injectionBiological

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

Study groups in NCT07563543
Study groupRoleWhat they receive
RN1701 treatment for relapsed/refractory B-cell lymphomaExperimentalPatients with relapsed/refractory B-cell lymphoma will receive a single dose of RN1701 cells.
Receives: Biological: RN1701 injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Toxicity and adverse event grading after RN1701 treatment

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

    Measured: up to 12 months after infusion

  2. 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

    Measured: up to 12 months after infusion

Secondary outcomes (5)

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

    according to the Lugano criteria and CSCO guidelines

    Measured: 1，3，6，and 12months after infusion

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

    according to the Lugano criteria and CSCO guidelines

    Measured: 1, 3, 6 and 12 months after infusion

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

    Tumor measurements and evaluations must be performed with the same technique used at baseline

    Measured: 1，3，6，and 12 months after infusion

  4. CAR copies of CAR-T in blood after RN1701 treatment

    CAR copies in copies/ug genome DNA

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

  5. Cell count of CAR-T in blood after RN1701 treatment

    Cell count of CAR-T in cells/ul

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2026
  2. Study start8 May 2026 (estimated)
  3. Primary completion30 May 2028 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07563543
Sponsor's protocol ID
2026-SR-269
Status last verified
Apr 2026
First submitted
23 Apr 2026
Last updated
4 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing RN1701 injection in people with Relapsed/Refractory B-cell Lymphoma, run by The First Affiliated Hospital with Nanjing Medical University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lei Fan (025-68306124, fanlei3014@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Toxicity and adverse event grading after RN1701 treatment (time frame: up to 12 months after infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07563543.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.

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