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OncoMatch/Clinical Trials/NCT06539338

A Study to Investigate Safety of INT2104 Infusions in Participants Aged 18 Years of Age and Older Who Have B-cell Cancers That Came Back After Previous Treatment

Is NCT06539338 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies non-drug interventions for lymphomas non-hodgkin's b-cell.

Phase 1RecruitingKite, A Gilead CompanyNCT06539338Data as of May 2026

The purpose of this first-in-human study is to evaluate the safety and tolerability of INT2104 when administered to humans in a broad population of participants with refractory/relapsing B-cell malignancies. Preliminary efficacy information may also be obtained. INT2104 is a gene therapy delivering a transgene for a chimeric antigen receptor (CAR) specific for CD20 (CAR20). The lentiviral vector is designed to generate CAR T and CAR Natural Killer (NK) cells inside the body following intravenous (IV) administration. Study details include the following: * The study duration will be 5 years * The treatment duration will be a one-time intravenous (IV) infusion of INT2104

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Extracted eligibility criteria

Cancer type

Acute Lymphoblastic Leukemia

Non-Hodgkin Lymphoma

Biomarker criteria

Required: MS4A1 antigen positive

B-NHL must have CD20 antigen positive tumour confirmed from a tumour biopsy taken at screening

Required: MS4A1 antigen positive

B-ALL participants must have CD20 antigen positive leukaemia

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 2 prior lines

Must have received: systemic therapy

Progression after at least 2 lines of systemic therapy

Cannot have received: CAR-T cell therapy or other genetically modified T-cell therapy

Exception: no more than one prior marketed CAR-T cell therapy (including tandem or bispecific CAR-T)

Has not received more than one prior marketed CAR-T cell therapy (including tandem or bispecific CAR-T) or other genetically modified T-cell therapy.

Cannot have received: donor lymphocyte infusion

Exception: within 6 weeks prior to INT2104 infusion

Participant has received donor lymphocyte infusion within 6 weeks prior to INT2104 infusion

Lab requirements

Blood counts

absolute lymphocyte count (alc) ≥300/µl; platelet count ≥50,000/ml; absolute neutrophil count (anc) ≥500/µl

Kidney function

adequate renal function

Liver function

adequate hepatic function

Cardiac function

adequate cardiac function

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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