Health TrialsbyHealthPanel

BCMA-CD19 cCAR in Multiple Myeloma and Plasmacytoid Lymphoma

ConditionsMultiple Myeloma in RelapseRefractory Multiple MyelomaPlasmacytoid; Lymphoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsoriCell Gene Therapeutics

About this trial

This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of BCMA-CD19 cCAR in patients with relapsed and/or refractory multiple myeloma and plasmacytoid lymphoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed written informed consent; Patients volunteer to participate in the research

Diagnosis is mainly based on the World Health Organization (WHO) 2008

Patients have exhausted standard therapeutic options

Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 1 weeks

Disqualifiers

Patients declining to consent for treatment

Prior solid organ transplantation

Potentially curative therapy including chemotherapy or hematopoietic cell transplant

Prior treatment with BCMAxCD3 or CD19xCD3 bispecific agents

Trial design

Design model

Sequential

Treatments tested in this trial

  • BCMA-CD19 cCAR T cells

    Biological/Vaccine

    BCMA-CD19 cCAR T cells administered to patients, will be either fresh or thawed CAR T cells by IV injection after receiving lymphodepleting chemotherapy

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: BCMA-CD19 cCARExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of adverse events after BCMA-CD19 cCAR T cells infusion

Determine the toxicity profile of BCMA-CD19 cCAR T cell therapy

Time frame
2 years particularly the first 28 days after infusion

Secondary outcomes

1

Incidence of treatment-emergent adverse events

Incidence of treatment-emergent adverse events

Time frame
up to 6 months

Other outcomes

1

For multiple myeloma - Stringent complete response

Stringent complete response (sCR) (IMWG criteria)

Time frame
24 months
2

For multiple myeloma - Complete response (CR)

Complete response (CR) (IMWG criteria)

Time frame
24 months
3

For multiple myeloma - Very good partial response (VGPR)

Very good partial response (VGPR) (IMWG criteria)

Time frame
24 months
4

For multiple myeloma - Partial response (PR)

Partial response (PR) (IMWG criteria)

Time frame
24 months

Sponsors and contacts

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

iCell Gene Therapeutics

Lead sponsor

iCAR Bio Therapeutics Ltd.

Collaborator

Peking University Shenzhen Hospital

Collaborator

Source ClinicalTrials.gov
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