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Study of Efficacy and Safety of CRC01 in Adult Large B-cell Lymphoma and B-cell Acute Lymphoblastic Leukemia Patients

ConditionsRelapsed Large B-cell LymphomaRefractory Large B-cell LymphomaDiffuse Large B-cell Lymphoma (DLBCL)Primary Mediastinal Large B-Cell Lymphoma (PMBCL)High-grade B-cell LymphomaTransformed Follicular Lymphoma (TFL)ALL (Acute B-Lymphoblastic Leukemia)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorCurocell Inc.

About this trial

This is a multi-center, phase I/II study to determine the efficacy and safety of CRC01 in adult patients with relapsed or refractory large B-cell lymphoma and B-cell Acute Lymphoblastic Leukemia.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥ 19 years of age and provided written informed consent

Histologically confirmed following large B-cell lymphomas according to the World Health Organization classification 2017

Diffuse large B-cell lymphoma, not otherwise specified Including Large cell transformation from follicular lymphoma (Transformed follicular lymphoma)

High-grade B-cell lymphoma, not otherwise specified

Disqualifiers

Patients with the following medical history

Adequately treated basal cell or squamous cell carcinoma without evidence of recurrence for at least 3 years prior to the study

In situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 3 years prior to the study

A primary malignancy which has been completely resected and in complete remission for ≥ 5 years

Trial design

Design model

Single group

Treatments tested in this trial

  • CRC01

    Biological/Vaccine

    Cohort A :A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells administered intravenously at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg. Cohort B :A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells administered intravenously at a target dose of 1.5 x 10\^6 anti-CD19 CAR T cells/kg.

  • Fludarabine

    Drug

    Administered according to package insert

  • Cyclophosphamide

    Drug

    Administered according to package insert

Treatment groups

91 Participants
are divided into 1 treatment group
Group A: CRC01Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Phase 1 Study: Maximum Tolerated Dose (MTD) which will be the Recommended Phase 2 Dose (RP2D)

Time frame
28 days
2

Phase 2 Pivotal Study: Cohort A : Overall Response Rate (ORR) Cohort B : Overall Complete Remission Rate (OCR)

Cohort A : ORR is defined as the incidence of either a complete response (CR) or a partial response (PR) per the Lugano Criteria for Response Assessment (2014). Cohort B : OCR is defined as the incidence of either a complete Remission (CR) or a Complete Remission with incomplete hematologic recovery (CRi) per the ALL Response Criteria.

Time frame
5 years

Secondary outcomes

1

Time to response (TTR)

Time frame
5 years
2

Duration of overall response (DOR)

Time frame
5 years
3

Event free survival (EFS)

Time frame
5 years
4

Progression free survival (PFS)

Time frame
5 years

Other outcomes

Sponsors and contacts

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

Curocell Inc.

Lead sponsor

Source ClinicalTrials.gov
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