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Lymphoma, B-Cell RefractoryPhase 1NCT07774572

Exploration of Circular RNA in B-cell Hematologic Malignancies

A Phase 1 study testing Investigational product (IP) in people with Lymphoma, B-Cell Refractory, run by Ruijin Hospital at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is an investigator-initiated, open-label, single-arm, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics (PD), and preliminary efficacy of an in vivo circular RNA chimeric antigen receptor T cell in adult participants with R/R B-cell malignancies. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma, B-Cell Refractory
What is being tested?
Investigational product (IP)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
2 sitesChina
Study dates
26 May 2026to Mar 2029
Phase
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years, any gender.
  • Able to provide written informed consent.
  • Confirmed diagnosis of relapsed/refractory (R/R) CD19-positive B-cell malignancy, including:
  • Diffuse large B-cell lymphoma (DLBCL)
  • Follicular lymphoma (FL)
  • Mantle cell lymphoma (MCL)
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  • Small lymphocytic lymphoma (SLL)/chronic lymphocytic leukemia (CLL)
  • Waldenström macroglobulinemia (WM)
  • Marginal zone lymphoma (MZL)
  • ECOG performance status 0 or 1.and have archival tumor biopsy tissue and pathology report from the most recent relapse, or at least one palpable superficial tumor lesion at screening, and agree to biopsy/resection before the first dose of IP for disease confirmation.
  • Disease refractory to or relapsed after ≥ 2 prior lines of standard therapy, including required agents per disease subtype (e.g., anti-CD20, BTK inhibitors, chemotherapy, or ASCT if applicable).
  • Measurable disease per Lugano 2014 or iwCLL 2018 criteria.
  • LVEF ≥ 40% by echocardiogram.
  • For patients with prior CD19-targeted therapy, confirmed CD19 positivity at screening.
  • Women of childbearing potential (WOCBP) must have a negative serum pregnancy test and agree to use effective contraception during the study and for 6 months after last treatment.
  • Male patients with female partners must agree to use condoms, and partners must use effective contraception, during the study and for 6 months after last treatment.

Who cannot join

  • Prior anticancer therapy-related toxicities unresolved to baseline or ≤ Grade 1 (alopecia and peripheral neuropathy excepted).
  • Central nervous system (CNS) involvement by lymphoma.
  • Need for urgent treatment due to tumor mass effect or spinal cord compression.
  • Known hypersensitivity to any component of IP, including mRNA/LNP-based products.
  • History of another primary malignancy within the past 3 years, except adequately treated basal cell carcinoma, squamous cell carcinoma, or cervical carcinoma in situ.
  • Active hepatitis B (HBsAg-positive with detectable HBV DNA) or hepatitis C (HCV RNA-positive) infection.
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  • Active or prior HIV infection.
  • Uncontrolled active systemic infection requiring IV therapy within 1 week before dosing.
  • Active or history of acute/chronic GVHD.
  • Inadequate hematologic function (ANC <1.0×10⁹/L, Hb <70 g/L, PLT <50×10⁹/L, lymphocytes ≤0.5×10⁹/L) or coagulation abnormalities (INR/APTT ≥1.5×ULN).
  • Hepatic impairment (ALT/AST >2×ULN, or >3×ULN with hepatic involvement; bilirubin >2×ULN, unless Gilbert syndrome).
  • Renal impairment (CrCl <50 mL/min by Cockcroft-Gault).
  • Uncontrolled ischemic heart disease, NYHA Class III-IV heart failure, or baseline QTcF ≥450 ms (male) / ≥470 ms (female).
  • Severe psychiatric disorder history.
  • Pregnancy or breastfeeding.
  • Received prohibited treatments within 4 weeks before dosing, including high-dose corticosteroids (>20 mg prednisone equivalent daily), chemotherapy, immunosuppressive therapy, prior CAR-T or other gene/cell therapy, or T-cell engagers.
  • Participation in another clinical study with investigational therapy within 3 months before dosing, or prior participation in cell/gene therapy trials.
  • Planned radiotherapy within 6 weeks after screening (unless only non-irradiated PET-positive lesions remain eligible).
  • Planned allogeneic HSCT within 90 days after screening.
  • Significant comorbidities or unstable medical conditions deemed by the investigator to compromise safety or study compliance.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Li WANG contact

（+86)15062338287

wl11194@rjh.com.cn

China2 sites, 2 recruiting

  • The Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality

    Li Wang, +86 15062338287, wl11194@rjh.com.cn

    qiuyanglin@medsi.cn

    Recruiting

  • Ruijin Hospital

    Shanghai

    Li WANG, 15062338287, wl11194@rjh.com.cn

    Not yet recruiting

Other trials in China

About this study

Official title: A Phase 1, Open-Label, Single-Arm, Dose-Escalation, Investigator-Initiated Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of an In Vivo Circular RNA Chimeric Antigen Receptor (CAR) T Cell Therapy in Adult Participants With Relapsed or Refractory B-Cell Malignancies

This is an investigator-initiated, open-label, single-arm, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics (PD), and preliminary efficacy of an in vivo circular RNA chimeric antigen receptor T cell in adult participants with R/R B-cell malignancies.

Read the detailed description

This is an investigator-initiated, open-label, single-arm, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics (PD), and preliminary efficacy of an in vivo circular RNA chimeric antigen receptor T cell in adult participants with R/R B-cell malignancies.

Investigational product (IP)will be explored across four dose levels (as described in the table below) in adult participants with R/R B-cell malignancies, including diffuse large B-cell lymphoma [DLBCL], follicular lymphoma [FL], mantle cell lymphoma [MCL], chronic lymphocytic leukemia [CLL]/small lymphocytic lymphoma [SLL], Waldenström macroglobulinemia [WM], and marginal zone lymphoma (MZL).

The study consists of three periods: screening period, treatment period, and post-treatment follow-up period.

Being tested
Investigational product (IP)
Medical subject headings
Lymphoma

What participants receive

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

  • Investigational product (IP)Drug

    In Vivo Circular RNA Chimeric Antigen Receptor (CAR) T Cell Therapy

Study groups in NCT07774572
Study groupRoleWhat they receive
Investigational product (IP)ExperimentalIn Vivo Circular RNA Chimeric Antigen Receptor (CAR) T Cell Therapy
Receives: Drug: Investigational product (IP)

What is being measured

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

  1. Incidence and severity of treatment-emergent adverse events (TEAEs)

    Count the number and percentage of participants with treatment-emergent adverse events (TEAEs). The severity of all TEAEs is graded according to CTCAE Version 5.0.

    Measured: From first dose of investigational product (IP) up to the end of study (Week 24 / EOS)

  2. Incidence of dose-limiting toxicities (DLTs)

    Count the number and percentage of participants who experience at least one dose-limiting toxicity (DLT) as defined by the study protocol.

    Measured: 28 days after the first dose of IP

Secondary outcomes (11)

  1. Overall Response Rate (ORR)

    Calculate the proportion of participants achieving Complete Response (CR) or Partial Response (PR). Tumor response is assessed per Lugano 2014 criteria, iWCLL 2018 criteria, and the 11th International WM Workshop criteria.

    Measured: From Week 4 through Week 24 (EOS)

  2. Time to Response (TTR)

    Evaluate the time interval from the first IP infusion to the first documented CR or PR.

    Measured: Up to Week 24 (EOS)

  3. Duration of Response (DOR)

    Evaluate the time interval from the first documented CR or PR to the first documented progressive disease (PD) or all-cause death, whichever occurs first.

    Measured: Up to Week 48 survival follow-up

  4. Event-Free Survival (EFS)

    Evaluate the time interval from the first IP infusion to the first documented PD, relapse, initiation of new anti-lymphoma therapy, or all-cause death, whichever occurs first.

    Measured: Up to Week 48 survival follow-up

  5. Progression-Free Survival (PFS)

    Evaluate the time interval from the first IP infusion to the first documented PD or all-cause death, whichever occurs first.

    Measured: Up to Week 48 survival follow-up

  6. Absolute count and percentage of CAR-expressing positive immune cells

    Detect and analyze the absolute count and percentage of CAR-expressing positive immune cells in peripheral blood at each time point, and assess dynamic changes from baseline.

    Measured: From pre-dose baseline through Week 24 (EOS)

  7. CD7 expression kinetics on immune cells

    Dynamically detect CD7 expression levels on peripheral blood immune cells at each time point and analyze kinetic changes from baseline.

    Measured: From pre-dose baseline through Week 24 (EOS)

  8. Overall Survival (OS)

    Evaluate the time interval from the first IP infusion to all-cause death.

    Measured: Up to Week 48 survival follow-up

  9. PK parameters of IP components

    Determine the PK parameters of the circRNA component and cationic lipid component of the IP respectively.

    Measured: From pre-dose baseline through Week 24 (EOS)

  10. Incidence of immunogenicity to IP

    Count the number and percentage of participants with pre-existing antibodies (anti-PEG, anti-CAR, anti-CD7 VHH) and treatment-induced antibodies (anti-PEG, anti-CAR, anti-CD7 VHH) against IP.

    Measured: From pre-dose baseline through Week 24 (EOS)

  11. Correlation between cytokine levels and treatment response adverse events(TRAE)

    Detect serum cytokine levels and conduct exploratory correlation analysis between cytokine concentrations and clinical outcomes.

    Measured: From pre-dose baseline through Week 24 (EOS)

Timeline

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

  1. First posted19 Aug 2026
  2. Study start26 May 2026
  3. Primary completionMar 2027 (estimated)
  4. Study completionMar 2029 (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
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07774572
Sponsor's protocol ID
RX-ONC-CS101
Status last verified
May 2026
First submitted
12 May 2026
Last updated
19 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Investigational product (IP) in people with Lymphoma, B-Cell Refractory, run by Ruijin Hospital at 2 sites in China.

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 16 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 Li WANG (（+86)15062338287, wl11194@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and severity of treatment-emergent adverse events (TEAEs) (time frame: From first dose of investigational product (IP) up to the end of study (Week 24 / EOS)). 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 NCT07774572.

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 19 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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