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DALY II Japan/MB-CART2019.1 for DLBCL

ConditionsDLBCL - Diffuse Large B Cell LymphomaCAR T Cell Therapy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMiltenyi Biomedicine GmbH

About this trial

DALY II Japan is a phase II, multi-center, single arm study to evaluate the efficacy, safety, and pharmacokinetics of zamtocabtagene autoleucel (MB-CART2019.1) in patients with relapsed and/or refractory diffuse large B cell lymphoma (DLBCL) after receiving at least two lines of therapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

DLBCL not otherwise specified (NOS)

High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements

High-grade B-cell lymphoma, NOS

Primary mediastinal (thymic) large B-cell lymphoma

Disqualifiers

Primary CNS lymphoma

Richter's transformed DLBCL arising from chronic lymphocytic leukemia (CLL)

Unable to give informed consent

Known history of infection with human immunodeficiency virus (HIV) or active hepatitis B (HBsAg positive), unless confirmed to be polymerase chain reaction (PCR) negative; antiviral prophylaxis is required as recommended in the Japanese guidelines for Hepatitis B treatment if HBsAg negative and anti-HBc positive

Trial design

Design model

Single group

Treatments tested in this trial

  • MB-CART2019.1

    Biological/Vaccine

    CAR T cell therapy

Treatment groups

31 Participants
are divided into 1 treatment group
Group A: MB-CART2019.1 in DLBCLExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective Response Rate

Objective Response Rate (ORR) (complete response rate \[CRR\] + partial response rate \[PRR\]) using Lugano 2014 Criteria (Cheson et al, 2014) at one month with independent central review

Time frame
1 month

Secondary outcomes

1

Complete Response Rate

Complete response rate using Lugano 2014 Criteria (Cheson et al, 2014) at 6 months.

Time frame
6 months
2

Duration of response

Duration of response (DOR)

Time frame
up to 2 years
3

Objective Response Rate

ORR using Lugano 2014 criteria (Cheson et al, 2014) at 6 months.

Time frame
6 months
4

Best Overall Response

Best overall response (BOR)

Time frame
2 years

Other outcomes

Sponsors and contacts

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

Miltenyi Biomedicine GmbH

Lead sponsor

Source ClinicalTrials.gov
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