NCT00881920: CHARKALL

Phase I Study of Adoptive Transfer of Autologous T Lymphocytes Engrafted With a Chimeric Antigen Receptor Targeting the Kappa Light Chain of Immunoglobulin Expressed in Patients With CLL, B-Cell Lymphoma or Multiple Myeloma

Active, enrolled Phase 1 Last updated 20 October 2025

What this trial tests

Phase 1 trial testing Kappa CD28 T cells in Lymphoma in 54 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 July 2009

Primary endpoint
1 July 2018

1 July 2035

Quick facts

Lead sponsor	Baylor College of Medicine
Phase	Phase 1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	54
Start date	1 July 2009
Primary completion	1 July 2018
Estimated completion	1 July 2035
Sites	2 locations across United States

Drugs / interventions tested

• Kappa CD28 T cells — full drug profile →

Conditions studied

• Lymphoma — all drugs for Lymphoma →
• Myeloma — all drugs for Myeloma →
• Leukemia — all drugs for Leukemia →

Sponsor

Baylor College of Medicine

Who can join

18 and older, any sex, with Lymphoma or Myeloma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Number of Patients with Dose-Limiting Toxicities (DLT)
  Time frame: 6 weeks
  DLT will be defined as any grade 3-5 toxicity that is NOT (1) pre-existing, or (2) due to infection (to which patients with CLL and NHL are so predisposed), or (3) due to underlying malignancy, and that is considered to be possibly, probably, or definitely related to the study drug. Toxicity will be evaluated using NCI criteria version 4.X.

Sponsor's own description

Patients have a type of cancer called NHL, Multiple Myeloma (MM) or CLL that has come back or has not gone away after treatment. There is no standard treatment for the cancer at this time or the currently used treatments do not work completely in all cases like these. This is a gene transfer research study using special immune cells.

The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancers. This research study combines two different ways of fighting disease, antibodies and T cells, that investigators hope will work together. Antibodies are types of proteins that protect the body from bacterial and other diseases. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including tumor cells. Both antibodies and T cells have been used to treat patients with cancers; they have shown promise, but have not been strong enough to cure most patients.

The antibody used in this study recognizes a protein on the lymphoma, MM or CLL cells called kappa immunoglobulin. Antibodies can stick to lymphoma, MM or CLL cells when it recognizes the kappa molecules present on the tumor cells. For this study, the kappa antibody has been changed so that instead of floating free in the blood it is now joined to the T cells. When an antibody is joined to a T cell in this way it is called a chimeric receptor. These chimeric receptor-T cells seem to kill some of the tumor, but they don't last very long and so their chances of fighting the cancer are limited.

In the laboratory, investigators found that T cells work better if they also add a protein that stimulates T cells to grow called CD28. By joining the anti-kappa antibody to the T cells and adding the CD28, the investigators expect to be able to make cells that will last for a longer time in the body (because of the presence of the CD28). They are hoping this will make the cells work better.

Previously, when patients enrolled on this study, they were assigned to one of three different doses of the kappa-CD28 T cells. We found that all three dose levels are safe. Now, the plan is to give patients the highest dose that we tested.

These chimeric T cells (kappa-CD28) are an investigational product not approved by the FDA.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Engineered T cells: the promise and challenges of cancer immunotherapy.
   Fesnak AD, June CH, Levine BL. · · 2016 · cited 812× · PMID 27550819 · DOI 10.1038/nrc.2016.97
2. Antibody-modified T cells: CARs take the front seat for hematologic malignancies.
   Maus MV, Grupp SA, Porter DL, June CH. · · 2014 · cited 474× · PMID 24578504 · DOI 10.1182/blood-2013-11-492231
3. Driving CAR T-cells forward.
   Jackson HJ, Rafiq S, Brentjens RJ. · · 2016 · cited 457× · PMID 27000958 · DOI 10.1038/nrclinonc.2016.36
4. Clinical responses with T lymphocytes targeting malignancy-associated κ light chains.
   Ramos CA, Savoldo B, Torrano V, Ballard B, et al · · 2016 · cited 232× · PMID 27270177 · DOI 10.1172/jci86000
5. Adoptive immunotherapy for cancer or viruses.
   Maus MV, Fraietta JA, Levine BL, Kalos M, et al · · 2014 · cited 221× · PMID 24423116 · DOI 10.1146/annurev-immunol-032713-120136
6. Redirecting T-cell specificity by introducing a tumor-specific chimeric antigen receptor.
   Jena B, Dotti G, Cooper LJ. · · 2010 · cited 210× · PMID 20439624 · DOI 10.1182/blood-2010-01-043737
7. Making Better Chimeric Antigen Receptors for Adoptive T-cell Therapy.
   Maus MV, June CH. · · 2016 · cited 205× · PMID 27084741 · DOI 10.1158/1078-0432.ccr-15-1433
8. Cancer immunotherapy beyond immune checkpoint inhibitors.
   Marin-Acevedo JA, Soyano AE, Dholaria B, Knutson KL, et al · · 2018 · cited 140× · PMID 29329556 · DOI 10.1186/s13045-017-0552-6