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Target-Selected CAR-NK Cells (CD30, CD5, or Mesothelin) for Relapsed/Refractory B2 Thymoma or Thymic Carcinoma

ConditionsB2 ThymomaThymic Carcinoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeijing Biotech

About this trial

This Phase 1/2 study evaluates the safety, tolerability, and preliminary efficacy of target-selected CAR-natural killer (CAR-NK) cells in adults with relapsed or refractory B2 thymoma or thymic carcinoma. Participants undergo centralized tumor antigen assessment (CD30, CD5, and mesothelin). Based on the dominant and clinically actionable antigen expression profile, each participant is assigned to one of three parallel cohorts (CD30-CAR-NK, CD5-CAR-NK, or mesothelin-CAR-NK). All cohorts use the same lymphodepleting conditioning regimen followed by CAR-NK infusion(s).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 to 75 years at the time of consent.

Histologically confirmed B2 thymoma or thymic carcinoma that is unresectable, metastatic, or recurrent.

Relapsed or refractory after at least 1 prior systemic therapy (including a platinum-based regimen for thymic carcinoma when appropriate) or no standard curative option available.

Tumor antigen positivity for at least one of the following by central laboratory assessment: CD30, CD5, or mesothelin. Cohort assignment is based on the dominant target (pre-specified algorithm) and feasibility of manufacturing/availability.

Disqualifiers

Active central nervous system involvement by malignancy requiring immediate therapy.

Prior gene-modified cellular therapy (e.g., CAR-T, CAR-NK) within 90 days or unresolved ≥Grade 2 toxicity from prior cellular therapy.

Uncontrolled infection, including active tuberculosis, or uncontrolled hepatitis B or C infection; known uncontrolled HIV infection.

Clinically significant autoimmune disease requiring systemic immunosuppression (e.g., >10 mg/day prednisone equivalent) within 14 days of conditioning, except for stable endocrine replacement.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cyclophosphamide

    Drug

    lymphodepletion

  • Fludarabine

    Drug

    lymphodepletion

  • EB-CAR30-NK

    Biological/Vaccine

    CD30-targeted allogeneic CAR-NK cells

  • EB-CAR5-NK

    Biological/Vaccine

    CD5-targeted allogeneic CAR-NK cells

  • EB-CARMSLN-NK

    Biological/Vaccine

    Mesothelin-targeted allogeneic CAR-NK cells

  • Rimiducid (AP1903)

    Drug

    ctivate the iCasp9 safety switch if clinically indicated

Treatment groups

36 Participants
are divided into 3 treatment groups
Group A: Cohort A: CD30-CAR-NKExperimental treatment 6 interventions
Group B: Cohort B: CD5-CAR-NKExperimental treatment 6 interventions
Group C: Cohort C: Mesothelin-CAR-NKExperimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

Incidence of Dose-Limiting Toxicities (DLTs)

DLTs as defined in protocol, assessed during the DLT window after the first CAR-NK infusion. Includes severe infusion-related toxicity, Grade \>=3 organ toxicity attributable to CAR-NK cells, severe CRS or neurotoxicity, and treatment-related death.

Time frame
28 Days
2

Recommended Phase 2 Dose

Determined separately for each cohort based on DLTs, overall safety, and pharmacodynamic data

Time frame
28 Days

Secondary outcomes

1

Objective Response Rate

Proportion of participants with complete response (CR) or partial response (PR) per RECIST v1.1 (or modified criteria appropriate for thymic tumors) in each cohort.

Time frame
12 months
2

Disease Control Rate

Proportion of participants with CR, PR, or stable disease

Time frame
12 months

Other outcomes

Sponsors and contacts

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Beijing Biotech

Lead sponsor

Source ClinicalTrials.gov
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