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Exploration of Circular RNA in B-cell Hematologic Malignancies

ConditionLymphoma, B-Cell Refractory
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorRuijin Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years, any gender.

Able to provide written informed consent.

Diffuse large B-cell lymphoma (DLBCL)

Follicular lymphoma (FL)

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Investigational product (IP)

    Drug

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

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Investigational product (IP)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame
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.

Time frame
28 days after the first dose of IP

Secondary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
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.

Time frame
Up to Week 48 survival follow-up

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ruijin Hospital

Lead sponsor

RiboX Therapeutics Ltd.

Collaborator

Source ClinicalTrials.gov
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