Antigen-targeted CAR T therapy for relapsed or high-risk B-cell lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center, open-label Phase 1 lead-in followed by a Phase 2 trial will determine the recommended Phase 2 dose and then test safety and efficacy of Epo-R–CD19 CAR T-cells with or without CD22 CAR T-cells in patients with relapsed or high‑risk B‑cell lymphoma. Eligible patients undergo leukapheresis and tumor antigen profiling, and CAR T products are manufactured based on CD19/CD22 expression. Patients receive lymphodepleting chemotherapy before infusion and are admitted for close monitoring for cytokine release syndrome and neurotoxicity. Primary endpoints include dose-limiting toxicities and RP2D in Phase 1, and response by PET-CT (Lugano criteria) plus CAR T expansion metrics and survival outcomes in Phase 2, with long-term follow-up.

Why it matters

Who can join: the full rules

Inclusion Criteria

* Age 10 to 80 years at screening
* PET-CT measurable disease by Lugano classification (Deauville score of ≥4) and
* Tissue biopsy of any tumour site and flow cytometry study of CD19 and CD22 expression.
* Relapsed B-cell lymphoma after one line of systemic therapy or autologous bone marrow transplant. This includes DLBCL, PMBCL, HGBCL, DLBCL arising from indolent lymphoma, Burkitt's lymphoma/leukemia, Mantle cell lymphoma.
* High risk B-cell lymphoma (BCL). High risk BCL is defined by any of the criteria below:

  * High-risk genetics - double/triple hit or p53mut or deletion.
  * IPI score ≥ 3
  * Richter's transformation from chronic lymphocytic leukaemia.
  * Disease refractory to treatment - PET-CT positive disease after 2 courses of rituximab-containing chemoimmunotherapy.
* PBMC product available
* Karnofsky or Lansky score \>70. Or ECOG 0-2
* Patient expected survival is more than 3 months to allow for manufacture and release of CAR T-cells.

Exclusion Criteria

* Patients who test positive on urine or blood pregnancy testing and are pregnant or are lactating.
* Participant of reproducible age who refuse the use of the following birth control methods if engaging in sexual activity that could lead to pregnancy. The methods include condoms, diaphragm, intrauterine device, hormonal based contraception.
* Concomitant genetic syndromes associated with BM failure states, such as Fanconi anaemia, Kostmann syndrome, Schwachman syndrome, or any other BM failure syndrome with the exception of Down syndrome.
* Active hepatitis B or hepatitis C within 3 months of screening.
* Active HIV infection within 3 months of screening.
* Grade 2 to 4 graft-vs-host disease (GVHD).
* Received an investigational medicinal product within 1 month of screening.
* If the total sum of CD19 and CD22 antigens expressed is less than 95.0%, patients will not be eligible. If subsequent immunophenotying of the patient's sample confirms that total sum of CD19 and CD22 antigens ≥ 95%, the patient may be rescreened.
* Central nervous system: Uncontrolled seizures or status epilepticus; decreased conscious state (any cause)
* Foreign patients who cannot commit to agreeable to stay in Singapore for at least 3 months post CAR T infusion and are committed to the long term monitoring post CAR T at home and in Singapore.
* Prior treatment with any CAR T cell therapy (approved or investigational)

Where it's running

• National University Hospital
  Singapore, Singapore, Singapore Recruiting

Study contacts

• Principal investigator: Michelle Poon — Nuhs
• Study coordinator: Michelle Poon
• Email: michelle_poon@nuhs.edu.sg
• Phone: 67724394

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Using Selinexor with ICE chemotherapy for B-cell lymphoma with CNS involvement

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• CAR-T cell therapy for adults with relapsed or refractory leukemia and lymphoma

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• CD19-targeted CAR‑T cell treatment for relapsed or refractory B‑cell leukemias and lymphomas

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.