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Novel Bispecific AbTCR (Anti-CD19/CD22)-T Cells in Relapsed or Refractory B-cell Lymphoma

ConditionsDiffuse Large B Cell Lymphoma (DLBCL)Follicular Lymphoma ( FL)Burkitt Lymphoma
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorFirst Affiliated Hospital Xi'an Jiaotong University

About this trial

This is an open-lable, single arm, non-randomized study to evaluate the primary safety and efficacy of the novel bispecific AbTCR (anti-CD19/CD22)-T cells in patients with relapsed or refractory B-cell lymphoma

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age≥ 18 years;

Pathologically diagnosed CD19+/CD22+ B-cell lymphoma;

Relapsed or refractory after at least two prior lines of therapy;

Cardiac function: Left ventricular ejection fraction ≥50%;

Disqualifiers

Lymphoma involving only the central nervous system (CNS), or secondary CNS lymphoma patients judged by the investigator to be at high risk for AbTCR (anti-CD19/CD22)-T cell therapy;

History of other malignancies not in complete remission for at least 2 years (the following conditions are exempt from the 2-year restriction: non-melanoma skin cancer, completely resected stage I tumors with low risk of recurrence, treated localized prostate cancer, biopsy-confirmed cervical carcinoma in situ, or PAP smear showing squamous intraepithelial lesion);

Positive hepatitis B surface antigen (HBsAg) (regardless of hepatitis B virus DNA copy number);

Positive hepatitis B core antibody (HBcAb) with increased hepatitis B virus DNA copy number;

Trial design

Design model

Single group

Treatments tested in this trial

  • Conditioning chemotherapy followed by AbTCR (anti-CD19/CD22)-T cell infusion

    Drug

    Cyclophosphamide 250 mg/m2 and fludarabine 30 mg/m2 IV infusion on day -5, -4, and -3. AbTCR (anti-CD19/CD22)-T cell IV infusion on day 0.

Treatment groups

3 Participants
are divided into 1 treatment group
Group A: Conditioning chemotherapy plus AbTCR (anti-CD19/CD22)-T cellsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Treatment-related Adverse Events

Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0) or ASTCT consensus.

Time frame
3 years

Secondary outcomes

1

Overall response rate (ORR) of administering AbTCR (anti-CD19/CD22)-T cells in relapsed/refractory B cell lymphoma.

ORR will be assessed from AbTCR (anti-CD19/CD22)-T cell infusion to death or last follow-up (censored).

Time frame
3 years
2

Overall survival (OS) of administering AbTCR (anti-CD19/CD22)-T cells in relapsed/refractory B-cell lymphoma.

OS will be assessed from AbTCR (anti-CD19/CD22)-T cell infusion to death or last follow-up (censored).

Time frame
3 years
3

Progress-free survival (PFS) of administering AbTCR (anti-CD19/CD22)-T cells in relapsed/refractory B-cell lymphoma.

PFS will be assessed from AbTCR (anti-CD19/CD22)-T cell infusion to death or last follow-up (censored).

Time frame
3 years
4

Duration of Response (DOR) of administering AbTCR (anti-CD19/CD22)-T cells in relapsed/refractory B-cell lymphoma.

DOR will be assessed from AbTCR (anti-CD19/CD22)-T cell infusion to death or last follow-up (censored).

Time frame
3 years

Other outcomes

1

Expansion, persistence, and infiltration of AbTCR (anti-CD19/CD22)-T cells in peripheral blood, bone marrow, and tumor tissues.

AbTCR (anti-CD19/CD22)-T cells will be determined by flow cytometry and ddPCR.

Time frame
3 years

Sponsors and contacts

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

First Affiliated Hospital Xi'an Jiaotong University

Lead sponsor

Eureka Therapeutics Inc.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: