A Phase 1 Study of JV-213 Autologous CD79b-targeting Chimeric Antigen Receptor T-cell Therapy in Adults With Relapsed or Refractory B-cell Lymphomas

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT05773040
Phase
PHASE1
Status
Recruiting
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Conditions

  • B-cell Lymphomas
  • Lymphomas

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • JV-213 — DRUG
    Given by (IV) vein
  • Leukapheresis — PROCEDURE
    Given by IV (vein)

Study Details

To find the highest tolerable dose of JV-213 (a type of autologous CAR T cell therapy) that can be given to patients who have B-cell lymphoma that is relapsed or refractory.

Key Dates

Start date
Apr 14, 2023
Status verified
May 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
33 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1 (dose escalation)
    Part 1, the dose of JV-213 participants receive will depend on when you join this study. Up to 3 dose levels of JV-213 will be tested. About 3-6 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level of JV-213. Each new group will receive a higher dose of JV-213 than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of JV-213 is found.
  • Experimental: Part 2 (dose expansion)
    Participants will receive JV-213 at the recommended dose that was found in Part 1.

Primary Outcome Measure

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5 [ Time Frame: through study completion; an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas M D Anderson Cancer CenterHoustonTexas77030
Sattva Neelapu, MD
[email protected]
713-563-3429
Sattva Neelapu, MD (PRINCIPAL_INVESTIGATOR)

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By research site
The University of Texas M D Anderson Cancer Center· Houston, TX

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